Search Results

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.

Ask a specific question about this device

MASTERGRAFT® Strip 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; MASTERGRAFT® Strip can also be used with autograft 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 or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

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

MASTERGRAFT® Strip is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip device, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% ß-tricalcium phosphate formulation. MASTERGRAFT® Strip is supplied sterile in a premixed strip form for single patient use.

MASTERGRAFT® Strip 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 and has been shown to heal bone defects.

MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler. MASTERGRAFT® Putty is a osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. MASTERGRAFT® Putty is biocompatible. MASTERGRAFT® Putty readily absorbs bone marrow aspirate and has been shown to heal bone defects.

The purpose of this Change Being Effected 510(k) is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Strip and MASTERGRAFT® Putty devices.

This document is a 510(k) summary for a medical device called MASTERGRAFT® (Strip and Putty). The purpose of this 510(k) is to add a new contraindication to the Instructions for Use (IFU).

Therefore, the submission demonstrates substantial equivalence by showing that the subject devices are identical to previously cleared predicate devices in several categories, rather than proving a new performance against acceptance criteria for a novel device. As such, many of the typical acceptance criteria and study design elements requested (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.

Here's the information that can be extracted based on the provided text, and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" and "reported device performance" are based on demonstrating substantial equivalence to predicate devices, focusing on the identity of technological characteristics.

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

• Not applicable. This 510(k) is a "Change Being Effected" for adding a new contraindication. No new clinical performance data from a "test set" was generated or reported for the purpose of demonstrating substantial equivalence for this specific submission. The established performance of the predicate device (which is deemed identical to the subject device) would have been based on prior studies. The document states: "No new non-clinical testing was performed or submitted in support of this 510(k)." The referenced animal studies for the original predicate devices are documented, but these are not "test sets" in the context of an AI/human performance study.

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

• Not applicable. No new "ground truth" was established for a test set in this submission. This is not a study involving expert assessment of a new device's output.

4. Adjudication method for the test set

• Not applicable. There was no "test set" or adjudication process described as part of this 510(k) submission for demonstrating new performance.

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 bone void filler, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

• Not applicable. This device is a physical bone void filler, not an algorithm.

7. The type of ground truth used

• Not applicable. As established, this submission relies on demonstrating substantial equivalence to predicates, not on generating new performance data against a "ground truth" for a novel device or algorithm. The performance of the predicate devices would have been established through methods like animal models (as referenced in Table 4: Ovine Femoral Defect Model, Rabbit Lumbar Intertransverse Process Fusion Model, Ovine Cortico-cancellous Defect Model for "in-vivo performance comparison" and "fusion results").

8. The sample size for the training set

• Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a training set.

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

• Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a training set.

Ask a specific question about this device