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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, 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 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 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 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.

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 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 proposed device modification is the addition of a new shape capture method, specifically the Ohio Willow Wood (OWW) Omega Scanner. Like the STARscanner Laser Data Acquisition system cleared with the STARlight (K021207 and K081994), the OWW Omega Scanner is a class 1 laser device. The OWW Omega Scanner is a handheld scanner consisting of two cameras, one laser, and eight LED lights.

The provided text describes a 510(k) submission for a modification to the STARlight Cranial Orthosis, specifically the addition of the Ohio Willow Wood (OWW) Omega Scanner as a new shape capture method. The study focuses on demonstrating the safety and efficacy of this new scanner.

Here's an analysis of the acceptance criteria and study as per your request:

Acceptance Criteria and Reported Device Performance

The core of this submission is the evaluation of the OWW Omega Scanner. The acceptance criteria and reported performance relate to its accuracy, reproducibility, and repeatability.

The document states, "The OWW Omega Scanner met the predetermined acceptance criteria and was found safe and effective for use with Cranial Orthoses." However, specific numerical thresholds for these criteria (e.g., a specific accuracy percentage, standard deviation for reproducibility) are not detailed in the provided text.

Study Details

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

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

   • Not specified. The study appears to be a technical validation of the scanner's performance (accuracy, reproducibility, repeatability) rather than a clinical study requiring expert ground truth for diagnosis or outcome measurement. The "ground truth" for scanner performance would likely involve physical measurements from a reference object or repeated scans, not expert consensus on patient data.

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

   • Not applicable as the study appears to be a technical validation of a measurement device, not a diagnostic or treatment outcome study requiring adjudication of expert interpretations.

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 comparative effectiveness study was done. This submission is for a physical measurement device (scanner) used to create an orthosis, not an AI-assisted diagnostic or interpretative tool.

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

   • The OWW Omega Scanner's performance (accuracy, reproducibility, repeatability) was evaluated in a standalone manner, meaning the scanner itself was tested for its ability to capture shape accurately and consistently. The results relate to the scanner's intrinsic technical performance.

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

   • The "ground truth" for this type of technical validation would typically involve a precisely known reference object or repeated measurements against a highly accurate standard. The document does not specify the exact nature of the ground truth, but it would not be expert consensus, pathology, or outcomes data in this context. It would be a physical reference standard or highly precise measurement method to compare the OWW Omega Scanner's output against.

7. The sample size for the training set:

   • Not applicable. The OWW Omega Scanner is a commercial device being integrated into a workflow, not a machine learning algorithm that requires a training set in the conventional sense.

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

   • Not applicable, as there is no training set for this device in the context of this submission.

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The STARlight is intended for medical purposes for use in 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 original three devices from 510(k) K021207 are made of a plastic shell of 5/32" -1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. Since the original clearance a variation of the STARlight Bivalve has been released. It is identical in design to the STARlight Bivalve, but 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.

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 Bivalve design and its variation 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 SEP 1 2 2008 510(k) summary provides details about the STARlight Cranial Orthosis, but it does not present a typical clinical study with acceptance criteria and device performance metrics in the way a diagnostic or AI-based device submission might. Instead, it focuses on demonstrating substantial equivalence to a predicate device and discussing changes to a related data acquisition system.

Therefore, it is not possible to fully complete the requested table and answer all questions as a traditional clinical study with acceptance criteria and measured device performance (e.g., sensitivity, specificity, accuracy) is not described for the STARlight device itself in this submission.

However, I can extract the information that is present regarding performance testing, particularly for the STARscanner™ Data Acquisition System.

Here's an attempt to answer the questions based on the provided document, highlighting what is not available:

Acceptance Criteria and Study Details for STARlight Cranial Orthosis

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing for the STARscanner™ Data Acquisition System, not the STARlight cranial orthosis itself. The "acceptance criteria" for the STARlight orthosis are implicitly related to its substantial equivalence to a predicate device and its continued successful use in clinical practice since 2002. For the STARscanner, the acceptance criterion was about achieving better accuracy than its predecessor.

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

• STARscanner: Three different cylindrical shapes (100mm, 125mm, 150mm diameters) were scanned. Each shape was scanned five times at five different positions.
• Data Provenance: Not explicitly stated, but implies laboratory testing of the scanner hardware. No information on human subject data provenance is provided for the orthosis's performance.

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

• STARscanner: "Standard measurement systems statistical process control procedures were utilized" – this implies metrology experts, but no specific number or qualifications are given.
• STARlight Orthosis: Not applicable as no such study is described for the orthosis's clinical performance.

4. Adjudication method for the test set:

• STARscanner: Not explicitly stated beyond "Standard measurement systems statistical process control procedures were utilized."
• STARlight Orthosis: Not applicable.

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 or AI-assisted study is described. The STARlight is a physical orthosis, and the STARscanner is a 3D scanner for head shape.

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

• No standalone algorithm performance study is described for the STARlight orthosis. The STARscanner is a measurement device, and its accuracy was tested in a standalone manner (without a "human-in-the-loop" influencing its measurement accuracy directly).

7. The type of ground truth used:

• STARscanner: The ground truth would be the known, precisely measured diameters of the three cylindrical shapes used in the testing.
• STARlight Orthosis: Not applicable for a clinical performance study. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

• Not applicable as the document describes a 510(k) submission for a physical device and a scanner, not a machine learning model.

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

• Not applicable.

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