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The STARband, STARlight, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

The STARband®, STARlight®, and St. Louis Band are custom made cranial orthoses. The STARband® and STARlight® redirect head growth to improve proportion and symmetry in infants with moderate-to-severe non-synostotic positional plagiocephaly. The practitioner takes a plaster impression or 3-dimensional captured image the head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® and STARlight® provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® and STARlight® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit. The proposed device modification is the addition of the CurveCapture application for iOS enabled device for a previously cleared shape capture method, the Net Virta SmartSoc™ System distributed by Orthomerica Products, Inc, used with the STARband, STARlight, and St. Louis Band devices. The system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade mobile phone device with a camera and a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. The CurveCapture™ application uses the camera on the device to take video footage of the patient wearing the SmartSoc. Specific images are then selected and sent to the cloud to be processed into a detailed 3D digital model of the patient's cranium.

The provided text describes a 510(k) submission for a medical device (cranial orthoses STARband, STARlight, and St. Louis Band) with a modification related to the associated 3D imaging system called SmartSoc. The modification involves the addition of an iOS-compatible application (CurveCapture) for the SmartSoc system. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and non-clinical performance data, particularly an accuracy study.

Here's a breakdown of the information requested based on the provided text:

Acceptance Criteria and Device Performance:

The document broadly states that the "Cranial Shape Capture Accuracy Verification was performed concluding that the SmartSoc™ System for iOS enabled device yields a safe and effective product that is substantially equivalent to the predicate device." It also mentions that the study compared the proposed device to a cast and the predicate device, considering "Associated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)."

However, specific numerical acceptance criteria (e.g., "accuracy must be within X mm") and the reported device performance values against those criteria are not explicitly stated in a quantitative table format within this summary. The text only indicates that the device met the criteria for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Cranial Shape Capture Accuracy Study" but does not specify the sample size for the test set (i.e., how many cranial shapes or subjects were included in this accuracy study). It also does not specify the geographic origin (country of origin) of the data or whether the study was retrospective or prospective. It only states that the study "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" and "Compared proposed device to cast and predicate device."

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the involvement of experts in establishing the ground truth for the test set. The ground truth seems to be based on a "representative cranial shape that possesses a predefined shape with known dimensions" and comparison to a physical "cast," implying an objective measurement rather than expert consensus on images.

4. Adjudication Method:

Given that expert involvement is not mentioned, an adjudication method (like 2+1 or 3+1) for the test set is not applicable and not described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This study focuses on the accuracy of the imaging system itself in capturing shape, not on the improvement of human readers' performance with or without AI assistance. The device is a shape capture system for orthotic fabrication, not a diagnostic imaging interpretation tool for humans.

6. Standalone (Algorithm Only) Performance:

The "Cranial Shape Capture Accuracy Study" described is essentially a standalone (algorithm only) performance study as it evaluates the ability of the SmartSoc System for iOS to accurately capture the "predefined shape with known dimensions" and compare it to a cast and the predicate device. It assesses the algorithm's output (3D digital model) directly.

7. Type of Ground Truth Used:

The ground truth used for the accuracy verification was:

• An objective, known "predefined shape with known dimensions" (likely a phantom or a precisely manufactured model).
• Comparison to a physical "cast" of a cranial shape.

This is not expert consensus, pathology, or outcomes data, but rather a direct measurement against a known physical standard.

8. Sample Size for the Training Set:

The document does not specify any training set size for the CurveCapture application or the SmartSoc system. This suggests that the development of the CurveCapture application might have relied on existing algorithms from the Android version, or that the training data details are not considered part of this simplified FDA summary for a Special 510(k). For a Special 510(k), significant changes to the algorithm often require more detailed information on training, but here the focus is on the "firmware expansion" and consistent technological characteristics.

9. How Ground Truth for Training Set was Established:

Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided.

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The St. Louis Band is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

The St. Louis Band redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The St. Louis Band provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the St. Louis Band directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The St. Louis Band (formally known as the O&P Bivalve Molding Helmet) was released in K063395. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit.

The proposed device modifications include:

(1) A clarification to the indications for use for the St. Louis Band. This change would have the device indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

(2) The addition of two new 3-dimensional shape capture methods, specifically, the STARscanner™ Data Acquisition System and the SmartSocTM System. The STARscanner is a stationary system that uses Class I Lasers and cameras to record surface data for shape capture. The SmartSoc System is a hand held system that uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Both of these shape capture systems are cleared with the STARband predicate device (K151979).

The provided text describes the acceptance criteria and study proving the device meets them for the Orthomerica Products, Inc. "St. Louis Band" cranial orthosis (K161138), primarily focusing on the addition of new 3D shape capture methods (STARscanner and SmartSoc System) rather than the orthosis itself.

Here's an analysis of the requested information, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details for Shape Capture Devices

This document primarily focuses on the validation of the new 3D shape capture methods (STARscanner and SmartSoc System) for manufacturing the St. Louis Band, not clinical efficacy of the band itself with these new methods.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Repeatability and Reproducibility (R&R) Analysis: "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." The specific number of shapes or scans is not provided.
   • Cranial Shape Capture Accuracy Study: "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." The specific number of shapes or scans is not provided.
   • Data Provenance: Not specified, but given the manufacturing context, it's likely internal testing by the manufacturer. It is not specified if it was retrospective or prospective, but the nature of the tests suggests bespoke testing/data collection.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • For both R&R and Accuracy studies, the ground truth was established by "uniform shapes with known dimensions" and a "representative cranial shape that possesses a predefined shape with known dimensions." This implies engineered or measured physical models, not human expert assessment of clinical cases. Therefore, no clinical experts were used for ground truth for these specific tests on the shape capture devices.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable as the ground truth was based on physical models with known dimensions. There was no clinical adjudication process described for these engineering validation tests.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No MRMC or comparative effectiveness study involving human readers or AI assistance in a clinical diagnostic context was described. The testing focused on the accuracy and precision of the shape capture devices for manufacturing, comparing them to a traditional casting method.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • The "standalone" performance here refers to the device's ability to accurately capture shape data compared to a physical reference ("casting process" or "known dimensions"). This was evaluated. The results indicate that the STARscanner and SmartSoc System "passed the acceptance criteria" and were "substantially equivalent" to the casting method in terms of accuracy and repeatability/reproducibility.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • For the R&R and Accuracy studies of the shape capture devices, the ground truth was based on known dimensions of uniform/representative physical shapes/models, not clinical data from patients or expert consensus.

7. The sample size for the training set

   • The document does not describe a "training set" in the context of an AI/machine learning algorithm. The tests are for the accuracy and precision of a measurement device, not a classification or diagnostic algorithm.

8. How the ground truth for the training set was established

   • Not applicable as no AI/ML training set is mentioned or implied. The ground truth for the validation tests was established by physical models with precisely known dimensions.

Ask a specific question about this device

The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The devices are also indicated for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband and STARlight product families as it was released in K141842 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap (1½" for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of a new 3-dimensional shape capture method, specifically, the Vorum Spectra™ 3D Scanner uses a high quality LED structured light projector and a single camera to detect the shape of the surface captured. This scanner utilizes LED light which is a non-coherent (i.e. non-laser) light source.

This document describes the acceptance criteria and study proving the device meets these criteria for the STARband® and STARlight® Cranial Orthosis, specifically focusing on the addition of the Vorum Spectra™ 3D Scanner as a new method for capturing infant head shape.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• R&R Analysis & Cranial Shape Capture Accuracy Study: The document mentions "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" for the R&R analysis, and "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" for the accuracy study. Specific numeric sample sizes are not provided in the given text.
• Data Provenance: The studies were conducted by Orthomerica Products, Inc., likely within their internal testing processes. The country of origin and whether the data was retrospective or prospective is not explicitly stated for these performance studies. However, as it's for a 510(k) submission, it would typically be prospective testing conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable for these engineering performance studies. The ground truth for the R&R analysis and Cranial Shape Capture Accuracy Study was established using "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions." This implies the "ground truth" was a precisely manufactured physical standard with measurable dimensions. No human expert interpretation was required.

4. Adjudication Method for the Test Set:

• Not applicable. As the ground truth was based on physical standards with known dimensions, human adjudication was not part of these engineering performance tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic device, but rather a medical device (cranial orthosis) with a new 3D scanning method for fabrication. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, effectively. The performance studies (R&R and Cranial Shape Capture Accuracy) evaluated the Spectra 3D Scanner itself (an "algorithm only" component in the context of data capture) against known physical standards and compared its results to existing methods (casting and predicate devices). The scanner's output (3D head shape data) is then used in a manufacturing process, but the studies focused on the performance of the scanner as a standalone data capture tool.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• For the Repeatability and Reproducibility (R&R) Analysis and Cranial Shape Capture Accuracy Study, the ground truth was based on known dimensions of uniform shapes and a predefined cranial shape. This is a form of physical/reference standard.
• For Material Biocompatibility Testing, the ground truth was established by standardized laboratory test procedures (e.g., scoring criteria for sensitization and irritation, cell reactivity grades for cytotoxicity).

8. The Sample Size for the Training Set:

• Not explicitly stated in the provided text. As this is a 510(k) submission for a physical device with a new input method (scanner) rather than a complex AI model, the concept of a separate "training set" for the device itself (cranial orthosis) is likely not applicable in the same way it would be for a machine learning algorithm. The scanner itself would have internal calibration and testing procedures during its development, but these are not detailed here.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as a separate "training set" for the device's clinical performance or the scanner's core functionality is not detailed as per the response to point 8. The "ground truth" for the performance studies shown here (R&R, Accuracy) was established through precisely manufactured physical standards.

Ask a specific question about this device

The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband and STARlight product families as it was released in K141842 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap (1½" for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of a new 3-dimensional shape capture method, specifically, the Rodin4D M4DScan System and the BodyScan System. The BodyScan System is the same as the M4DScan System (Hardware and Software included) except it is distributed in the United States by TechMed 3D, Inc. on behalf of Rodin4D. This system uses a structured white light projector and a single camera to detect the shape of the surface captured. This system utilizes LED white light which is a non-coherent (i.e. non-laser) light source. Because this system utilizes a non-coherent light source, it is safe to use on infant patients under all circumstances.

This document describes the 510(k) premarket notification for the STARband and STARlight Cranial Orthosis, specifically focusing on the addition of the Rodin4D M4DScan System and the BodyScan System as new 3-dimensional shape capture methods.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily states that the devices "passed the acceptance criteria" and demonstrated "substantial equivalence" rather than explicitly delineating numerical thresholds for acceptance. The acceptance criteria are inferred from the stated purpose of the tests (comparing to predicate/casting process and finding substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance

• R&R Analysis & Cranial Shape Capture Accuracy Study:
  • Sample Size: The document states the tests "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" and "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" (Page 9). However, specific numerical sample sizes for the test set (number of uniform shapes, number of measurements, etc.) are not provided.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study appears to be a laboratory/benchtop study using uniform or representative cranial shapes, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• R&R Analysis & Cranial Shape Capture Accuracy Study: The ground truth was established by "predefined shape with known dimensions" of uniform or representative cranial shapes (Page 9). This implies that the ground truth was based on engineered or calibrated measurements of these physical models, not expert human assessment. Therefore, no experts were used to establish the ground truth for these specific tests.

4. Adjudication Method for the Test Set

• Since the ground truth was based on precisely measured physical models or known dimensions, and not human interpretation, no adjudication method (like 2+1, 3+1) was necessary or performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was mentioned or performed. The clearance is for a medical device (cranial orthosis) and a new shape capture method, not an AI diagnostic algorithm that assists human readers.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

• Yes, a standalone study was performed for the shape capture devices. The R&R Analysis and Cranial Shape Capture Accuracy Study directly evaluated the performance of the M4DScan/BodyScan System itself in accurately capturing known shapes, comparing its measurements to predefined dimensions (ground truth) and to other existing shape capture methods (casting process and predicate devices). This is essentially a standalone performance evaluation of the new technology.

7. The Type of Ground Truth Used

• For the R&R Analysis and Cranial Shape Capture Accuracy Study: The ground truth used was based on "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions." This is akin to engineered ground truth or physical model measurements, where the true dimensions are precisely known.
• For Biocompatibility Testing: The ground truth was established by recognized biological assay standards and methodologies (e.g., scoring systems for sensitization, irritation, and cytotoxicity) as per ISO 10993 standards (implied, though not explicitly cited in detail).

8. The Sample Size for the Training Set

• This document is for a medical device and a shape capture method, not an AI model that requires a "training set" in the machine learning sense. The device is a physical orthosis and the M4DScan/BodyScan system is a 3D scanner.
• Therefore, the concept of a "training set" as traditionally understood for machine learning models is not applicable here, and no specific training set sample size is mentioned.

9. How the Ground Truth for the Training Set Was Established

• As the concept of a "training set" is not applicable, the establishment of ground truth for a training set is also not relevant to this submission.

Ask a specific question about this device

The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap (1½" for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is a new software component for a previously cleared shape capture method, the STARscanner™ Data Acquisition System. The new software component is the Cranial Comparison Utility (CCU). The CCU is a separate software program that is designed to present specific measurements derived from a threedimensional (3D) digital model of a patient's cranium. These features are useful to medical professionals by providing more detailed shape data that can be incorporated into the patient evaluation/assessment and for tracking cranial head shape changes.

1. A table of acceptance criteria and the reported device performance:

The document describes the Cranial Comparison Utility (CCU) as a software component for the previously cleared STARscanner™ Data Acquisition System, which is used for the fabrication of STARband and STARlight Cranial Orthoses. The acceptance criteria and performance data specifically address the CCU.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document states that the "CCU Accuracy and Capabilities Study" "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." It does not specify a numerical sample size in terms of the number of unique patient scans or models. Instead, it refers to a single "representative cranial shape." This suggests a phantom or a standardized model rather than a dataset of patient scans.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a "representative cranial shape" with "predefined shape and known dimensions," it is highly likely this refers to a synthetic or phantom model used in a controlled laboratory setting, rather than real patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the number or qualifications of experts used to establish the ground truth for the CCU's test set. The ground truth was established by "predefined shape with known dimensions" and "manual measurements and 3D-CAD software." This suggests that the ground truth was derived from engineering specifications and objective measurements rather than subjective expert consensus on patient data.

4. Adjudication method for the test set:

Not applicable. The ground truth for the CCU's performance was established using objective "predefined shape with known dimensions" and comparison to "manual measurements and 3D-CAD software." There was no multi-reader or human adjudication process described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The CCU is a software tool for measurement and analysis of 3D cranial models, not an AI-assisted diagnostic tool for human readers. It provides "more detailed shape data that can be incorporated into the patient evaluation/assessment and for tracking cranial head shape changes" by medical professionals, but it does not describe human reader performance with or without the CCU.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone study evaluating the CCU (algorithm only) was performed. The "CCU Accuracy and Capabilities Study" assessed the accuracy of measurements and capabilities entirely of the software by comparing its output to "manual measurements and 3D-CAD software" on a "representative cranial shape."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for the CCU's accuracy and capabilities study was based on:

• "Predefined shape with known dimensions" of a representative cranial shape. This implies a precisely manufactured physical model or a digitally engineered model with exact specifications.
• Comparison to "manual measurements and 3D-CAD software." This suggests that precise reference measurements from established tools were used as the gold standard.

8. The sample size for the training set:

The document does not describe a "training set" for the CCU. This suggests that the CCU software likely relies on deterministic algorithms for geometric measurements and comparisons, rather than machine learning models that require training data.

9. How the ground truth for the training set was established:
As no training set is described for the CCU, the method for establishing its ground truth is not applicable.

Ask a specific question about this device

The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1½' for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of a new 3-dimensional shape capture, specifically, the NetVirta SmartSoc™ System distributed by Orthomerica Products, Inc. This system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source.

The provided document describes the FDA 510(k) summary for the STARband and STARlight Cranial Orthosis, specifically focusing on the addition of the NetVirta SmartSoc™ System for 3-dimensional shape capture. The document outlines non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for the SmartSoc System's performance in terms of cranial shape capture. Instead, it states that the conclusion of the studies was that the "Proposed device is substantially equivalent to predicate device." The studies were designed to compare the SmartSoc System against a cast and the predicate device (presumably the previously approved imaging devices for the STARband/STARlight).

However, the document does describe the types of tests performed and their general conclusions:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for R&R and Accuracy Studies: The document states for R&R, it "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." For the Accuracy Study, it "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." Crucially, the exact number of these "uniform shapes" or "representative cranial shapes" (i.e., the n for the test set) is not specified. This is a significant omission from the provided summary.
• Data Provenance: The studies appear to be in vitro or phantom-based studies ("uniform shapes," "representative cranial shape") rather than involving human subjects. Therefore, concerns about country of origin, retrospective/prospective, are not directly applicable in the way they would be for patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or not specified. Ground truth appears to have been established by "known dimensions" of the uniform/representative shapes and comparison against physical casts. There's no mention of human expert involvement in defining the "truth" for these technical accuracy studies.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the technical studies on shape capture involved predefined, known physical dimensions and comparisons to physical casts, not subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies focus on the technical accuracy and consistency of the 3D capture system itself, not on how human readers/practitioners improve with or without AI assistance in diagnosis or treatment planning.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the studies described (Repeatability and Reproducibility, Cranial Shape Capture Accuracy) assess the performance of the SmartSoc System itself (algorithm and hardware) in capturing shapes accurately and consistently, independent of human interpretation of the captured data for clinical decision-making. The "device" in this context is the SmartSoc system which captures the 3D shape, and its output (the 3D image) is then used to manufacture the orthosis. The studies verify the fidelity of this capture process.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For the Repeatability and Reproducibility (R&R) Testing Analysis and Cranial Shape Capture Accuracy Study, the ground truth was based on known physical dimensions of "uniform shapes" or "representative cranial shapes" with "predefined shape with known dimensions." The system's output was also compared to "cast and predicate device." This suggests a physical phantom/model comparison with known measurements.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. This document is a 510(k) summary for a medical device (cranial orthosis) with a new imaging modality (SmartSoc System). It focuses on validation testing of the new modality. It does not provide details of any internal training data used by the SmartSoc system's algorithms, if applicable. The SmartSoc system uses "a customized non-repetitive printed pattern" on a flexible fabric sock; its internal algorithms for 3D reconstruction would have been developed and trained by NetVirta, but those details are not in this FDA summary.

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth: Not specified in this document for the reasons mentioned in point 8.

Ask a specific question about this device

The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband and STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylenepolypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1 ½' for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of three new systems to use for 3dimensional shape capture, specifically, the 3dMDhead™ System, the 3dMDcranial™ System and the 3dMDflex™ System all distributed by 3dMD, Inc. These systems use a non-coherent (i.e. non-laser light) structured light source and triangulated cameras to capture shape data.

The provided 510(k) summary (K140353) concerns the addition of three new 3D imaging systems (3dMDhead™ System, 3dMDcranial™ System, and 3dMDflex™ System) for use with the existing STARband® and STARlight® Cranial Orthosis. The primary goal of the submission is to demonstrate that these new 3D capture systems are substantially equivalent to previously cleared 3D imaging devices for the same cranial orthosis fabrication.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the 3dMD Systems are primarily based on demonstrating repeatability, reproducibility, and accuracy in shape capture, and biocompatibility of the materials used in the orthosis itself. The performance is assessed by substantiating equivalence to predicate devices and established methods.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Repeatability & Reproducibility Analysis: Not explicitly stated as a number of "samples." The study "utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." This suggests a set of standardized models rather than clinical patient data.
• Sample Size for Cranial Shape Capture Accuracy Study: Not explicitly stated as a number of "samples." The study "utilized a representative cranial shape that possesses a predefined shape with known dimensions." This also suggests a focus on physical models rather than patient data.
• Data Provenance: The studies appear to be laboratory-based validation studies using physical models ("uniform shapes," "representative cranial shape") rather than retrospective or prospective clinical patient data. Therefore, country of origin related to patient data is not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the involvement of "experts" in establishing the ground truth for the test sets (uniform shapes, representative cranial shape). The ground truth was based on the "known dimensions" and "predefined shape" of these physical models.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on the known, predefined dimensions of physical models rather than human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed for this submission. The focus was on the accuracy, repeatability, and reproducibility of the 3D scanning systems themselves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies conducted for the 3dMD Systems (Repeatability & Reproducibility Analysis, Cranial Shape Capture Accuracy Study) assessed the performance of the scanning technology in isolation, or "standalone," by comparing its measurements to the known dimensions of physical models. This does not involve a "human-in-the-loop" aspect for the performance evaluation of the scanner itself.

7. Type of Ground Truth Used

The ground truth used was based on the known dimensions and predefined shapes of physical models ("uniform shapes with known dimensions," "representative cranial shape that possesses a predefined shape with known dimensions").

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the context of machine learning. The 3dMD Systems are described as using "non-coherent (i.e. non-laser light) structured light source and triangulated cameras to capture shape data," which implies a direct measurement technology rather than a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a training set for a machine learning algorithm is not described in the document.

Ask a specific question about this device

The STARlight is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalicand scaphocephalic-shaped heads.

The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARlight product family as it was released in K090587 are essentially still the same devices. The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4'' to 3/8" clear Surlyn. The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of a new shape capture method. specifically the scanGogh-11" by Vorum Research, Inc. This scanner uses one laser, either Class 1 or Class 2 depending on the option, and one camera to capture shape data. The Class I laser option of the scanGogh-II is as safe as other scanner devices previously cleared for the STARlight and will not require any extra safety precautions. The Class 2 laser option is safe to use on infant patients when used in conjunction with eye protection. The Class I laser option of the scanGogh-II shall be the recommended option for scanning infants. If the Class 2 option of the scanGogh-II is used, the infant should wear eye protection as instructed in the proposed labeling.

Here's a breakdown of the acceptance criteria and study information for the STARlight® Cranial Orthosis, based on the provided text:

Acceptance Criteria and Device Performance

The core of this submission is the addition of a new shape capture method, the scanGogh-II, for the STARlight Cranial Orthosis. The acceptance criteria and performance are tied to the accuracy of this new scanner compared to existing methods.

Table of Acceptance Criteria and Reported Device Performance

Study Information

2. Sample size used for the test set and the data provenance

• Sample Size:
  • For the Cranial Shape Capture Accuracy Study: "a representative cranial shape that possesses a predefined shape with known dimensions" was utilized. This implies a single, standardized phantom or model rather than a dataset of patient scans.
  • For the Repeatability and Reproducibility (R&R) Analysis: "uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" were utilized. No specific number is given, but it implies a set of phantoms or models.
  • For the Eye Shield Fit Assessment: "infants" were assessed. No specific number is provided.
• Data Provenance: The studies appear to be prospective in nature, conducted specifically for this submission. The "country of origin" for this data is not explicitly stated, but given the company's location (Orlando, FL) and FDA submission, it's presumed to be within the US or compliant with US standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The ground truth for the Cranial Shape Capture Accuracy Study and R&R Analysis was established using "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions". This suggests that the ground truth was based on pre-defined, precisely measured physical models or phantoms, rather than relying on human expert consensus or clinical data. Therefore, no human experts were explicitly mentioned as establishing the ground truth for the performance testing of the scanner itself.

4. Adjudication method for the test set

• Not applicable as the ground truth was established by known physical dimensions of models/phantoms, not by human review requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was performed or needed. This device is a cranial orthosis and a new scanning method. There is no "human reader" component in the sense of image interpretation for diagnosis that would benefit from AI assistance. The scanning method replaces manual measurement or other digital scanning methods.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, the performance of the scanGogh-II (the algorithm/hardware for shape capture) was evaluated in a standalone manner against known physical dimensions without a human-in-the-loop performance scenario in the context of the Cranial Shape Capture Accuracy Study and R&R Analysis.

7. The type of ground truth used

• Known physical dimensions of uniform and representative cranial shapes/phantoms. This is a form of engineered or precisely measured ground truth.

8. The sample size for the training set

• The document does not describe any "training set" in the context of machine learning or AI. This submission is for a physical medical device (cranial orthosis) and a new shape capture tool. The scanGogh-II is a scanner, not an AI algorithm that would typically require a training set to learn.

9. How the ground truth for the training set was established

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

Ask a specific question about this device

The STARband is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalicand scaphocephalic-shaped heads.

The STARband redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from using polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion. The STARband consists of a 5/32" outer copolymer shell with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). There is a top opening and a side opening. The strap across the side opening is 1 ½" Dacron and Velcro and is attached to the STARband with a chafe and loop. A ½" pelite polyethylene foam gap block fills any gap in the side opening. The proposed device modification is the addition of a new shape capture method, specifically the scanGogh-II" by Vorum Research, Inc. This scanner uses one laser and one camera to capture shape data.

Acceptance Criteria and Device Performance Study for STARband® Cranial Orthosis

This document describes the acceptance criteria and the study that demonstrates the STARband® Cranial Orthosis, specifically with the integration of the scanGogh-II scanner, meets these criteria.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified STARband® Cranial Orthosis with the scanGogh-II scanner were established through a comparison to the predicate device (STARband cleared in K082950) and a traditional plaster cast method. The study aimed to demonstrate that the scanGogh-II, as a new head shape capture method, performed at least as well as, or superior to, the existing methods for capturing cranial shape parameters.

Table of Acceptance Criteria and Reported Device Performance (scanGogh-II vs. Cast Method):

"Pass (Superior)" in the reported device performance indicates that the scanGogh-II accuracy performed superior to the Cast method.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document states that the testing "utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." However, a specific numerical sample size for the test set (i.e., the number of cranial shapes used) is not explicitly provided in the summary.
• Data Provenance: The study appears to be an ex-vivo or in-vitro study using "uniform shapes with known dimensions." It does not involve human subjects or retrospective/prospective patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention using human experts to establish the ground truth for the test set. The ground truth was based on "uniform shapes with known dimensions," implying pre-engineered or precisely measured physical models.

4. Adjudication Method for the Test Set

The concept of an adjudication method by experts is not applicable here, as the ground truth was based on known dimensions of physical models rather than subjective interpretation of medical data. The comparison was quantitative, against predefined measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study conducted. This study focused on the accuracy of a shape capture device (scanGogh-II) compared to existing methods (cast and predicate device), not on the improvement of human readers with AI assistance. The device is a tool to create orthoses, not an AI diagnostic aid requiring human interpretation of output.

6. Standalone Performance Study

Yes, a standalone performance study was done for the scanGogh-II scanner. The "Cranial Shape Capture Accuracy Study" directly evaluates the scanGogh-II by comparing its output (captured dimensions) to the known dimensions of representative cranial shapes. The scanGogh-II's accuracy, reproducibility, and repeatability were assessed independent of human intervention in the interpretation of the scan data itself.

7. Type of Ground Truth Used

The ground truth used was based on known dimensions of "representative cranial shapes." These are likely engineered models or phantoms with precisely defined measurements for various cranial parameters (e.g., A-P length, M-L width, various radii, squareness, and flatness). This is a metrological ground truth.

8. Sample Size for the Training Set

The document does not provide information regarding a training set sample size. The modification involves a new shape capture method (scanner), not a machine learning algorithm that typically requires a large training dataset. The evaluation is for the accuracy and consistency of the measurement device itself.

9. How the Ground Truth for the Training Set Was Established

As no training set is discussed or implied for the scanGogh-II's function as a shape capture device, the method for establishing its ground truth is not applicable in this context. The study focuses on evaluating the scanner's performance against predefined physical standards, not on training an AI model.

Ask a specific question about this device

The STARlight is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion. The proposed modification is the addition of the STARlight PRO design, which is an amalgamation of the STARlight Side Opening design and the STARlight Cap design. The STARlight Side Opening design, STARlight Bi-Valve design and the STARlight Cap design are all made of a plastic shell of 5/32" -- 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design uses a 1/4" to 3/8" clear Surlyn shell for patients with a head circumference over 18" (over approximately 1 year of age) and a 5/32" to 1/4" clear Surlyn shell for all patients with a head circumference less than 18". The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design. The STARlight Cap design is made of the above plastic and contains no straps. The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bivalve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The provided text is a 510(k) Summary for a device modification, specifically the STARlight® Cranial Orthosis. It describes the device, its intended use, and compares the modified device to its predicate. However, it does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The FDA letter (Sections 5-7) confirms that the device is substantially equivalent to legally marketed predicate devices, but this is a regulatory determination based on comparison of technological characteristics and indications for use, not on a new study demonstrating performance against specific acceptance criteria.

The submission is for a "Special 510(k)" for a device modification, which means that the sponsor is asserting that the changes do not raise new questions of safety or effectiveness and can be considered substantially equivalent to the previously cleared device without extensive new performance data. The core principle of operation remains the same ("applies pressure to the prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape"). The main change is an increase in material thickness for the STARlight PRO design, intended for older, larger-headed infants, to provide increased rigidity. The submission argues that this change is minor and does not alter the fundamental mechanism or clinical effect.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment because this data is not present in the provided document. The document describes a medical device, its intended use, and modifications, but does not include clinical efficacy studies or performance metrics with predefined acceptance criteria.

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