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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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