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The OsteoSymbionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.

The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill cranial defects in a specific patient. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided sterile and are attached to the native bone with commercially available cranioplasty fasteners.

The provided text details a 510(k) submission for the "OsteoSymbionics Patient-Specific Cranial Implant Device." However, it does not contain any information about a study involving AI or human readers, nor does it provide specific acceptance criteria or performance data for a device leveraging AI.

The submission focuses on establishing substantial equivalence for a physical medical device (a patient-specific cranial implant made of polymethyl methacrylate) based on a change from non-sterile to sterile packaging. The evaluation for this device is based on "comparative analysis of physical properties and biocompatibility through standardized testing" and "sterilization and packaging validations."

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI or a "study that proves the device meets the acceptance criteria" in that context.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, training set sample size, or how ground truth for training was established.

This document is solely about the regulatory clearance of a physical medical implant, not an AI-driven diagnostic or analytical device.

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OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.

OsteoSymbionics Patient-Specific Cranial Implant (PEEK), manufactured by OsteoSymbionics, LLC, is a prosthetic cranioplasty implant. Each implant is sized and shaped from one or more pieces to fit the specific patient's cranial skeleton. The devices are manufactured from PEEK and provided non-sterile for sterilization prior to implantation. Implantable prosthetic cranioplasty implants are intended to fill a specific patient's defect, so each device is manufactured one at a time to custom-order based upon the patient's CT scan. The device can be crafted to include perfusion holes (2mm in diameter, spaced 10mm apart) upon surgeon preference (on order sheet). The implants are attached to the native bone with commercially available cranioplasty fasteners.

Here's a breakdown of the acceptance criteria and study information based on the provided K121102 document, organized as requested:

Acceptance Criteria and Study Information for OsteoSymbionics PEEK Patient-Specific Cranial Implant

This device is a PEEK Patient-Specific Cranial Implant, which is a physical medical device, not an AI/software device. Therefore, the questions related to AI performance, ground truth establishment, training sets, and expert adjudication are not applicable in the context of this 510(k) submission. The equivalence is established through material biocompatibility, manufacturing process validation, and mechanical testing, demonstrating comparability to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical implant and not an AI-driven diagnostic device, the acceptance criteria are not typically expressed in terms of sensitivity, specificity, or accuracy. Instead, they focus on material properties, manufacturing validation, and mechanical performance comparable to existing devices.

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

• Sample Size: Not explicitly stated in terms of patient sample size for performance evaluation. For mechanical and material testing, the "sample size" refers to the number of test specimens. This document does not specify those numbers.
• Data Provenance: Not applicable in the context of clinical data provenance for an AI device. The data refers to material testing, manufacturing process validation, and software validation. Specific locations or retrospective/prospective nature are not detailed, but it would have been conducted as part of the device development and validation process by OsteoSymbionics, LLC.

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

Not applicable, as this is a physical medical implant, not an AI diagnostic device requiring expert-established ground truth from clinical cases.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance of medical imaging interpretation by human readers, often with and without AI assistance. This device is a physical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is based on established engineering principles, material science standards, and performance specifications for cranioplasty implants.

• Biocompatibility: Adherence to ISO standards for medical device biocompatibility.
• Mechanical Performance: Comparison to the known mechanical properties of the predicate PMMA implant and other PEEK cranial implants, likely through standardized ASTM or ISO mechanical testing (e.g., strength, fatigue, impact resistance).
• Manufacturing Quality: Validation of the manufacturing process to ensure consistency and sterility.
• Software Validation: Confirmation that the software used in the design and manufacturing process performs as intended.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).

The OsteoSymbionics Temporal Implants are pre-formed implantable prosthetic implants intended to fill soft-tissue defects in a patient's cranial/craniofacial temporal region. The implants are composed of longterm implantable-grade solid silicone elastomer. The implants are available in left and right, and come in two different sizes, small and medium. The devices are provided sterile, and are attached to native tissue with commercially available suture materials.

The provided document describes the OsteoSymbionics Temporal Implant, a pre-formed silicone elastomer implant intended to fill soft-tissue defects in the temporal region of the cranium.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The "acceptance criteria" are not explicitly stated as quantitative targets in the provided text. Instead, the document describes the types of tests performed to demonstrate that the device is "substantially equivalent" to predicate devices. For most criteria, the performance is described as "tested" or "comparable," without specific numerical values.

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

The document does not provide details on sample sizes for specific tests (e.g., number of units tested for tensile strength, number of cultures for bioburden). It also does not mention the country of origin of the data or whether the data was retrospective or prospective, as the testing described is primarily laboratory-based product characterization.

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

This information is not applicable and not provided. The "test set" here refers to the physical device and its material properties, not a set of clinical cases requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As mentioned above, the "test set" is related to product characteristics, not clinical assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The summary describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Clinical studies comparing human reader performance with and without AI assistance are not part of this type of submission for this device.

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

This question is not applicable to the OsteoSymbionics Temporal Implant. This is a physical medical device (an implant), not a software algorithm or an AI-powered diagnostic tool. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the material and physical property testing, the "ground truth" would be established by standardized laboratory methods and industry specifications for implantable-grade materials. For biocompatibility, it's established by recognized cytotoxic assays. For sterility, it's based on microbiological testing standards. The comparison for chemical characteristics relies on literature comparison to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical implant, not an AI model, so there is no "training set."

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

This information is not applicable and not provided, as there is no training set for this type of device.

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The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.

The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial/craniofacial skeleton. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners.

This document is a 510(k) Summary of Safety and Effectiveness for the OsteoSymbionics Patient-Specific Cranial Implant. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided text.

Based on the provided text, here's what can be extracted and what is not available:

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

This information is not available in the provided text. The document is a 510(k) summary demonstrating substantial equivalence for a physical implant, not a study evaluating specific performance metrics against pre-defined acceptance criteria.

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

This information is not available. Since this is a 510(k) for a physical implant, there's no mention of a "test set" in the context of evaluating algorithm performance or diagnostic accuracy using patient data. The device is manufactured based on individual patient CT imaging data.

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 available. There is no "test set" in the context of diagnostic performance that would require ground truth established by experts. The "ground truth" for the implant design is the patient's individual CT imaging data of their cranial defect.

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

This information is not available. There is no "test set" and thus no adjudication method 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 applicable and not available. This document is for a physical patient-specific cranial implant, not an AI/software device intended to assist human readers or provide diagnostic interpretations.

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

This information is not applicable and not available. The device described is a physical implant, not an algorithm.

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

For the design and manufacturing of the implant, the "ground truth" for the patient's anatomy and defect is the patient's CT imaging data.

8. The sample size for the training set

This information is not applicable and not available. The device is a physical implant custom-made for each patient; there is no "training set" in the context of an algorithm.

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

This information is not applicable and not available.

In summary, the provided text is a regulatory submission for a physical medical device (patient-specific cranial implant) under a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the kind of performance study details typically associated with the evaluation of AI/software medical devices, as it is not an AI/software device.

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