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MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

MASTERGRAFT® Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip form for single patient use. The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate.

This FDA 510(k) summary for Medtronic's MASTERGRAFT® Matrix EXT bone void filler does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered medical device.

Instead, this document is a Traditional 510(k) application focused on demonstrating substantial equivalence to previously cleared predicate devices. The primary purpose of this specific submission is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Matrix EXT.

Therefore, many of the requested points regarding AI/ML device testing are not applicable to this document. The document describes a traditional medical device (bioresorbable collagen and calcium phosphate ceramic) and its non-clinical testing for substantial equivalence, not an AI/ML algorithm's performance.

Here's an analysis based on the provided text, highlighting what's available and what's not:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. This document does not describe specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, or image analysis accuracy) for an AI/ML device. The "performance" mentioned refers to the general function and characteristics of the bone void filler, which are deemed "Identical" to the predicate devices.

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

• Not Applicable. No test set in the context of evaluating an AI/ML algorithm's performance is mentioned. The non-clinical testing refers to tests conducted on the physical device, not on data for algorithm evaluation.

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. Ground truth, in the AI/ML sense, is not established or discussed in this document.

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

• Not Applicable. Adjudication methods for test sets are not relevant to this type of device submission.

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. No MRMC study or AI assistance is mentioned.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• Not Applicable. Ground truth in this context is not defined as there is no algorithm being evaluated against such a benchmark. The "ground truth" for this device would be its physical and chemical properties and its biological interaction with bone, evaluated through non-clinical (e.g., biocompatibility, dissolution rate) and potentially clinical studies (which are referenced as already having occurred for the predicate).

8. The sample size for the training set

• Not Applicable. No training set for an AI/ML algorithm is mentioned.

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

• Not Applicable.

Summary of Device and Substantial Equivalence Information Present in the Document:

The document describes the MASTERGRAFT® Matrix EXT, a resorbable calcium salt bone void filler device.

• Device Description:

  • Made from medical-grade purified collagen of bovine origin (Type I, >95%) and biphasic calcium phosphate ceramic (15% hydroxyapatite and 85% ß-tricalcium phosphate).
  • Supplied sterile in a premixed strip form for single patient use.
  • A biocompatible, osteoconductive, porous implant that supports bony ingrowth and resorbs at a rate consistent with bone healing.
  • Absorbs bone marrow aspirate.

• Indications for Use:

  • To be combined with autogenous bone marrow.
  • Indicated for bony voids or gaps not intrinsic to the stability of the bony structure.
  • Can be used as a bone graft extender.
  • Gently packed into bony voids or gaps of the skeletal system (posterolateral spine, pelvis, ilium, and/or extremities).
  • For surgically created osseous defects or those from traumatic injury.
  • Resorbs and is replaced with bone during healing.

• Predicate Devices:

  • MASTERGRAFT® UltraMatrix (K130335, S.E. 04/19/2013)
  • MASTERGRAFT® Strip and MASTERGRAFT® Putty (K140375, S.E. 04/18/2014)

• Basis for Substantial Equivalence (Non-Clinical Testing):

  • The submission relies on non-clinical testing performed in support of MASTERGRAFT® Strip (K082166, S.E. 06/02/2009), which is considered relevant and supportive of the cited predicate K130335.
  • No new non-clinical testing was performed or submitted for this specific 510(k) application.
  • Testing was conducted in accordance with FDA Recognized Consensus Standards and FDA Guidelines.
  • The subject device is deemed substantially equivalent to the predicate MASTERGRAFT® UltraMatrix due to identical:
    • Indication for Use
    • Fundamental Scientific Technology/Operating Principle/Mechanism of Action
    • Basic Design
    • Performance
    • Manufacturing principles
    • Sterilization
    • Shelf-Life
    • Packaging
    • Material Composition (collagen, granules)
    • Use of rigid fixation
    • Safety and Effectiveness profile
  • It is also substantially equivalent to K140375 (MASTERGRAFT® Strip and MASTERGRAFT® Putty) regarding the additional contraindication identified in the labeling (which was the primary purpose of this specific 510(k)).

In essence, this document is a regulatory submission for a material-based medical device, not a software-based or AI/ML device, and thus the requested AI/ML specific information is not available within this text.

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