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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 indications for use would include infants from three to eighteen months of age to be treated for Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of the P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. This device is to be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.

It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly.

This 510(k) summary (K012804) for the Plagiocephalic Applied Pressure (P.A.P.) Orthosis does not provide the detailed information requested regarding acceptance criteria, study design, or performance metrics in the way that would be expected for a device proving performance against specific acceptance criteria. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets predefined performance benchmarks through a clinical study.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission focuses on substantial equivalence based on function, purpose, and intended use to existing predicate devices (D.O.C. band K964992 and STARband K001167). There are no specific performance criteria or benchmarks listed for the P.A.P. Orthosis itself.

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

This information is not provided. As this is a substantial equivalence submission, it does not detail a clinical study with a test set.

3. 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):

This information is not provided. There is no mention of a test set or ground truth establishment by experts for performance evaluation.

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

This information is not provided. No test set is 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:

This information is not provided. The device is an orthosis, not an AI-assisted diagnostic tool, so an MRMC study would not be applicable.

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

This information is not provided. The device is an orthosis, not an algorithm.

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

This information is not applicable as there is no described study with a ground truth. The "ground truth" in a substantial equivalence submission is essentially the proven safety and efficacy of the predicate devices.

8. The sample size for the training set:

This information is not provided. There is no mention of a training set as would be found in an algorithm-based device.

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

This information is not provided. No training set is described.

Summary based on the provided text:

The submission for the P.A.P. Orthosis (K012804) is a 510(k) premarket notification demonstrating substantial equivalence to two legally marketed predicate devices: the D.O.C. band (K964992) and the STARband (K001167).

• Acceptance Criteria & Performance: The document does not specify quantitative acceptance criteria or detailed performance data for the P.A.P. Orthosis itself. Instead, it argues that the device is "similar in function and purpose" and has the "same intended use" as the predicate devices, implying that their established safety and effectiveness are the basis for acceptance. The performance is indirectly "reported" by stating it "more completely encompasses the cranium with clear copolymer plastic" compared to the predicate, while serving the same purpose.
• Study Data: No specific study data, sample sizes, or ground truth establishment methods are detailed because this type of submission relies on demonstrating similarity to existing, approved devices rather than presenting novel clinical study results.
• Ground Truth (Implicit): The "ground truth" for the P.A.P. Orthosis's suitability is the regulatory history and proven safety/efficacy of the predicate devices (D.O.C. band and STARband) for treating moderate to severe nonsynostotic positional plagiocephaly, brachycephaly, or scaphocephaly in infants aged three to eighteen months.

In essence, the "study" proving the device meets "acceptance criteria" here is the comparison made by the applicant to existing predicate devices, and the FDA's subsequent determination that this comparison is valid for substantial equivalence.

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The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).

The Lerman & Son Cranial Orthosis Helmet is a custom made orthosis used to treat children between the ages of three and eighteen months for abnormal head shapes. Through the concavity formed during the design of this helmet, the skull is encouraged to grow in a more normal manner.

This is a premarket notification (510(k)) for a cranial orthosis helmet, not a study evaluating a device's performance against acceptance criteria using advanced AI or imaging technology. Therefore, the requested information elements related to AI, statistical studies, expert ground truth, and training/test sets are not applicable to this document.

The document establishes substantial equivalence to a predicate device, Orthomerica STARband (K001167), primarily by comparing design, materials, intended use, and other key specifications.

Here's a breakdown of the relevant information from the provided document:

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

The document does not present "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to a predicate device. The "reported device performance" is essentially that it matches the predicate device in key characteristics.

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

Not applicable. This is a 510(k) submission focusing on substantial equivalence, not a clinical trial with a "test set" to evaluate performance. There is no mention of a specific test set or data provenance in this document beyond the predicate device's existing clearance.

3. 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)

Not applicable. No "ground truth" was established for a test set in the context of this 510(k) submission. Substantial equivalence relies on comparing the device to an already legally marketed predicate, not on new clinical data requiring expert review for ground truth.

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

Not applicable. There was no "test set" or adjudication method described in this 510(k) submission.

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

Not applicable. This device is a physical cranial orthosis helmet and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

Not applicable. This device is a physical medical device, not a software algorithm.

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

Not applicable. The concept of "ground truth" as used in testing AI or diagnostic devices is not relevant here. The "truth" for this submission is based on the established safety and effectiveness of the predicate device (Orthomerica STARband K001167).

8. The sample size for the training set

Not applicable. This is a physical device, and the submission does not involve machine learning or a "training set."

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

Not applicable. As there is no training set mentioned, there is no ground truth established for it.

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