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The PEEK Patient Specific Cranial Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.

The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc. The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a 510(k) summary for a medical device (PEEK Patient Specific Cranial/Craniofacial Implant).

It details:

• The device's identification and intended use
• Comparison to a predicate device
• Non-clinical testing for biocompatibility and performance (compression, fitting, fixation)
• A statement that no clinical tests were performed.

Therefore, there is no mention of acceptance criteria based on device performance in a clinical study, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training sets. This information would typically be found in a clinical study report, which is not present here.

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The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.

The KLS Martin LSS Plating System includes plates and screws that are intended to be used in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, where applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness of each plate ranges from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire.

This document is a 510(k) premarket notification for the KLS Martin LSS Plating System, a medical device for sternal closure. The document states that clinical testing was not necessary to support substantial equivalence (page 4). Therefore, the information typically requested regarding acceptance criteria based on clinical studies, sample sizes, expert involvement, and ground truth establishment is not available in this filing.

However, the document does describe non-clinical mechanical testing performed to demonstrate that the device met performance standards. Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria", I will extract the information related to the mechanical testing, which serves as the "study" in this case for demonstrating safety and effectiveness for substantial equivalence.

Here's a summary of the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document doesn't explicitly state numerical acceptance criteria values. The implied acceptance criterion for each test is to perform "equivalently or better" than the predicate devices or to demonstrate acceptable mechanical behavior for its intended use.

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

• Sample Size: The document does not specify the exact number of samples (e.g., number of plates or screws) used for each mechanical test. It mentions "various apparatus set-ups" and "a series of tensile tests."
• Data Provenance: Not applicable in the context of mechanical, non-clinical testing. This was laboratory testing, not human-subject data.

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

• Not applicable. This was non-clinical mechanical testing.

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

• Not applicable. This was non-clinical mechanical testing.

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 was non-clinical mechanical testing of a physical device, not an AI-assisted diagnostic device.

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

• No. This was non-clinical mechanical testing of a physical device.

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

• Ground Truth: For mechanical testing, the "ground truth" is established by engineering principles, accepted testing standards, and comparison with the known performance of legally marketed predicate devices, as well as general expectations for structural integrity and durability.

8. The sample size for the training set:

• Not applicable. This was non-clinical mechanical testing, not a machine learning study.

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

• Not applicable. This was non-clinical mechanical testing, not a machine learning study.

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