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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 and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured inage 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 last cleared in K180109 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 St. Louis Band (formally known as the O&P Bivalve Molding Helmet in K063395) was last cleared in K180109 by Orthomerica Products Inc. 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 Cranial Comparison Utility (CCU) is a software component for a previously cleared shape capture method, the STARscanner Data Acquisition System, distributed by Orthomerica Products, Inc. The CCU is a separate software program that is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.

The proposed addition is a new software component for a previously cleared shape capture method, the NetVirta SmartSoc Data Acquisition System, distributed by Orthomerica Products, Inc. The new software component is the Measurement Comparison Utility (MCU). The MCU is a separate software program, not used in manufacturing, which is designed to present specific measurements derived from a threedimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.

The provided document describes a 510(k) premarket notification for Orthomerica Products Inc.'s cranial orthoses (STARband, STARlight, and St. Louis Band) with the addition of a new software component, the Measurement Comparison Utility (MCU). The acceptance criteria and supporting study details are primarily focused on the MCU Accuracy and Capabilities Study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the MCU's performance was evaluated against the predicate Cranial Comparison Utility (CCU) and manual/3D-CAD software measurements. The reported device performance is that the MCU was determined to be substantially equivalent to the predicate CCU.

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

• Test Set Sample Size: The document states that the MCU Accuracy and Capabilities Study "Utilized representative cranial shapes that reflect symmetrical and asymmetrical cranial shapes." However, it does not specify the exact number (sample size) of these cranial shapes used in the test set.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It refers to "representative cranial shapes," which could be phantom models or de-identified patient data.

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

The document states that the MCU was "Compared... to manual measurements and 3D-CAD software." This implies that the ground truth for some measurements was established through manual methods and potentially by experts using 3D-CAD software. However, the document does not specify the number of experts used or their qualifications.

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this submission. The focus was on the performance of the software (MCU) in comparison to established methods (manual measurements, 3D-CAD, and predicate software).

6. Standalone (Algorithm Only) Performance

A standalone performance study was performed. The "MCU Accuracy and Capabilities Study" evaluates the MCU software program itself, without human intervention in its measurement calculations or reporting. It compares the MCU's outputs to manual measurements and 3D-CAD software.

7. Type of Ground Truth Used

The ground truth used for the MCU Accuracy and Capabilities Study was:

• Manual measurements
• 3D-CAD software measurements

This combination provided a reference for assessing the accuracy of the MCU's measurements and capabilities.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The MCU is described as a software component designed to present specific measurements from 3D digital models. It seems to function as a measurement and comparison tool rather than a machine learning algorithm that requires a traditional training set for model development in this context. The study focuses on its accuracy for processing existing 3D models.

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

Since a training set is not explicitly mentioned as relevant for this type of software (a measurement utility rather than a predictive model), the document does not describe how ground truth for a training set was established.

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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 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:

• Negligible Dermal Response (for Primary Dermal Irritation)
• Non-cytotoxic (for Cytotoxicity – Agar Diffusion) | All materials (Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam) met the acceptance criteria for non-sensitization, negligible dermal irritation, and non-cytotoxicity (with one noted slight reactivity for Copolymer with Aliplast Foam, still deemed non-cytotoxic). |

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.

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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.

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