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The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "RTS Flexible 1st MPJ Implant w/Grommets." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as typically understood for a new clinical efficacy study, is largely not applicable in this context.

Here's why and what information can be extracted based on the document:

No specific acceptance criteria or performance metrics are provided in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. This device is a surgical implant, not a diagnostic AI device. The "performance data" referred to are related to engineering, cleaning, packaging, and sterilization validation, not clinical performance metrics.
No "study" as a clinical trial comparing device performance to acceptance criteria in the manner of an AI/diagnostic device is presented. The "study" here is essentially the demonstration of substantial equivalence.

However, I can extract the relevant information that is present in the document based on your request, highlighting where the requested details are not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (explicitly stated in the document)	Reported Device Performance (as per the document)
None explicitly stated as clinical performance metrics (e.g., sensitivity, specificity, accuracy) for statistical thresholds.	No clinical performance metrics are reported.
Substantial Equivalence to Predicate Device (Futura Biomedical, Flexible Great Toe Implant, K981194) in:	Demonstrated.
- Intended Use	Same
- Indications for Use	Same
- Similar Dimensions	Yes
- Similar Geometry	Yes
- Similar Materials	Yes
- Principals of operation	Same
- Cleaning validation	Performed, results demonstrate substantial equivalence.
- Packaging validation	Performed, results demonstrate substantial equivalence.
- Sterilization validation	Performed, results demonstrate substantial equivalence.
- Engineering analysis	Performed, results demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance

Not Applicable. This document describes a 510(k) submission for a surgical implant, not a study involving a "test set" of data for algorithm performance. The "performance data" mentioned refers to engineering and validation testing (e.g., cleaning, packaging, sterilization), not clinical outcome data or diagnostic performance data. Therefore, there's no "sample size" or "data provenance" in the context of an AI/diagnostic algorithm test set.

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

Not Applicable. As above, no "test set" for expert-derived ground truth is described in this 510(k) submission.

4. Adjudication method for the test set

Not Applicable. No test set or related adjudication method is mentioned.

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 is a surgical implant, not a diagnostic AI device. Therefore, MRMC studies and concepts of human reader improvement with/without AI assistance are not relevant to this submission.

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

Not Applicable. This is a surgical implant. There is no algorithm or AI component involved.

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

Not Applicable. The "ground truth" in this context is the predicate device and its established safety and effectiveness. The current device aims to demonstrate "substantial equivalence" to this predicate, rather than generating new primary ground truth for clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not Applicable. There is no training set or associated ground truth establishment process for a training set in this submission.

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