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This prosthesis can be used to reconstruct defects of the stapes and the incus.
This prosthesis can be used to reconstruct an absent or defective stapes and incus.

The Exmoor Teflon Loop will be offered in two sizes. Each comprises one element, the shaft of which is 6.0mm long and is either 0.4mm or 0.6mm in diameter. The loop has an internal dimension of 0.7mm to fit the malleus for the replacement of the stapes and the incus. Secure closure is provided by "plastic memory". The outside diameter of the loop is either 1.5mm or 1.9mm.

The provided document is a 510(k) premarket notification for a medical device (Exmoor Teflon Loop Replacement Prosthesis) and does not contain the information required to answer the prompt.

Specifically, the document focuses on establishing substantial equivalence to predicate devices and receiving clearance from the FDA. It does not include:

1. Acceptance criteria and reported device performance: This document only describes the device and its intended use, with no data on its performance against specific metrics.
2. Sample size and data provenance for a test set: No study data is presented.
3. Number and qualifications of experts for ground truth: Not applicable as no study data is presented.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not mentioned or conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document primarily states that the device is "made of exactly the same material as all four of the predicate devices and is intended to perform exactly the same function," which is the basis for its substantial equivalence claim, rather than presenting a detailed performance study.

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