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MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities.

MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum.

MedXpert's P.E.S. implant system is consisting out of straight bars which can be bended according to the individual anatomic needs of the patient and different stabilizer which can be attached to the bar and secured by the BarLock™ Pin.

MedXpert's STRATOS™ implant system is consisting out of Bar and Rip Clips; Rip Clips are combined by press fit with the bar and with the rips.

The provided text is a 510(k) summary for the MedXpert P.E.S. and STRATOS™ implant systems. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a specific study proving device performance against those criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not available in this document. The document primarily serves to establish regulatory equivalence based on intended use and device description.

Here's a breakdown of what can be gleaned and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The 510(k) summary does not define specific performance acceptance criteria or report on device performance against such criteria. It relies on demonstrating substantial equivalence to legally marketed predicate devices, implying that if it's equivalent, it meets the same performance standards (which are not explicitly detailed here).

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

Not applicable/Not available. This 510(k) relies on substantial equivalence. There is no mention of a "test set" in the context of clinical performance evaluation (e.g., using patient data). The evaluation appears to be based on comparison of design, materials, and intended use with existing devices.

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

Not applicable/Not available. As there is no "test set" in the sense of patient data requiring ground truth establishment, this information is not relevant to the content provided.

4. Adjudication Method for the Test Set

Not applicable/Not available. This document does not describe a study involving adjudication of a test set.

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

No, a MRMC study was not done. The document makes no mention of any clinical comparative effectiveness study, especially one involving human readers and AI assistance.

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

No, a standalone performance study was not done. This device is a physical implant system, not a software algorithm that would have standalone performance measured.

7. The Type of Ground Truth Used

Not applicable/Not available. Without a study involving analysis of patient data or clinical outcomes against a "ground truth," this concept does not apply to the provided 510(k) summary. The "ground truth" in a 510(k) for substantial equivalence is often the performance and safety record of the predicate devices.

8. The Sample Size for the Training Set

Not applicable/Not available. This 510(k) is for a physical medical implant, not an AI/ML algorithm that requires a training set.

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

Not applicable/Not available. This is not relevant for the type of device and regulatory submission presented.

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