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The GMRS Adapter is intended to mate the Proximal Femoral Components and Femoral Bodies of the MRS or Proximal Femoral Body or Extension Pieces of the GMRS to the distal femoral stems of the Restoration™M Modular Hip System. The GMRS adapter is intended for use with the above-noted components in proximal femoral replacement indicated in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Adequate bone stock must be present to allow the use of the Restoration™ Modular Distal Femoral Stems. Indications and contraindications of the GMRS Adapter when used with the Proximal Femoral Bodies of the MRS and GMRS, and the distal femoral stems of the Restoration™ Modular Hip System follow:

Indications

Proximal femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

The GMRS Adapter is a single use, two piece design consisting of the Adapter and the Adapter Locking Screw The GMRS Adapter is fabricated from titanium alloy (titanium -6 Aluminum-4 Vanadium) and is available in four sizes: standard, +10mm, +20mm, and +30mm. The proximal portion of the GMRS Adapter serves as the male portion of a taper lock that is assembled to the female taper in the distal end of the MRS or GMRS Proximal Femoral Component or Extension Pieces. The distal portion of the GMRS Adapter contains a female taper that accepts the male taper of the Restoration™ Modular Distal Femoral Stems. There are scribe marks on the GMRS Adapter to allow the surgeon to orient the amount of anteversion of the MRS or GMRS Proximal Femoral Component. The proximal portion of the male taper of the GMRS Adapter contains a female thread that serves two purposes: 1) to accept the GMRS Adapter Locking Screw after the taper lock has been engaged; and 2) for mating with a separation instrument should the surgeon need to reposition the adapter after it has been assembled to the Distal Stems of the Restoration™ Modular Total Hip System.

The GMRS Adapter Locking Screw is fabricated from titanium alloy (titanium- 6 Aluminum -4 Vanadium) and is available in four sizes that correspond to the sizes of the Adapter: standard; +10mm, +20mm, and +30mm. The GMRS Adapter Locking Screw is used to augment the taper lock of the GMRS Adapter into the Restoration™ Modular Distal Femoral Stems. The GMRS Adapter Locking Screw is packaged with the corresponding size GMRS Adapter.

This document is a 510(k) summary for the Global Modular Replacement System (GMRS) Adapter, a medical device for hip replacement. The information provided heavily focuses on the device's intended use, description, indications, and contraindications. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in the prompt.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

Here's why, based on the requested points:

1. A table of acceptance criteria and the reported device performance: Not found. The document describes the device and its intended use, but no performance metrics are mentioned.
2. Sample size used for the test set and the data provenance: Not found. No studies involving test sets are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found. No information about expert review or ground truth is provided.
4. Adjudication method: Not found. No adjudication process is mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not found. The document is not a study report; it's a regulatory submission summary.
6. Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.
7. Type of ground truth used: Not found. No ground truth is established as no performance study is described.
8. Sample size for the training set: Not applicable/Not found. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable/Not found.

The document essentially states what the device is, what it's used for, and who it's for, in the context of a regulatory submission seeking substantial equivalence. It does not provide the kind of study data typically associated with performance evaluation and acceptance criteria.

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