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Patient Contoured Mesh – PEEK (PCM-P) is intended to replace bony voids in the cranial and/or craniofacial skeleton

Patient Contoured Mesh - PEEK (PCM-P) is a custom shaped PEEK panel that is pre-shaped to fit the anatomy of the patient using a CT based model of the patient. Patient Contoured Mesh - PEEK (PCM-P) is fixated using standard KLS Martin's titanium plates and screws in sizes 1.0mm through 2.3mm

The provided document is a 510(k) summary for a medical device called "Patient Contoured Mesh – PEEK (PCM-P)". This type of document is typically for premarket notification and focuses on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about studies proving the device's performance against specific acceptance criteria, nor does it describe clinical trials with human subjects or detailed performance metrics as would be found in a clinical study report.

Instead, the document asserts substantial equivalence based on intended use, technological characteristics, and material composition to highlight similarities and differences with predicate devices.

Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Not Available. The document does not specify quantitative acceptance criteria or report specific performance metrics for the PCM-P device. The approval is based on "substantial equivalence" to predicate devices, meaning it is considered as safe and effective as existing legally marketed devices, not necessarily meeting a new set of defined performance criteria through a dedicated study in this document.

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

• Not Available. This document does not describe a clinical performance study with a test set. The device is custom-shaped based on individual patient CT scans.

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 / Not Available. This device is a custom implant. While medical professionals (e.g., surgeons, radiologists) would be involved in patient selection and providing CT data, the document does not describe a "ground truth" establishment process for a performance study in the typical sense of diagnostic or AI device evaluation.

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

• Not Applicable / Not Available. There is no performance study described that would require an adjudication method for a test set.

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 implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical custom-shaped implant. While the shaping process uses CT data, the document does not discuss "algorithm only" performance in the context of diagnostic or AI systems. The design process involves human input (e.g., surgeon's input on desired shape).

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

• Not Applicable / Not Available. For custom implants, the "ground truth" is generally considered to be the patient's actual anatomy derived from imaging (like CT scans) and the clinical need assessed by a surgeon. This is not a diagnostic device where a "ground truth" is established for disease presence.

8. The sample size for the training set

• Not Applicable. This device is a custom-made implant based on an individual patient's CT scan. There isn't a "training set" in the context of machine learning. Each implant is designed fresh for each patient.

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

• Not Applicable. As there's no training set in the machine learning sense, this question is not relevant to the information provided.

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