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Mastergraft™ Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps 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, intervertebral disc space, 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. When used in intervertebral body fusion procedures, Mastergraft™ Matrix EXT must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

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 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, intervertebral disc space, 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. When used in intervertebral body fusion procedures, Mastergraft™ Strip must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

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 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, intervertebral disc space, pelvis, ileum, 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. When used in intervertebral body fusion procedures, Mastergraft™ Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mastergraft™ Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, Mastergraff™ Granules can be used with autograft as a bone graft extender. Mastergraft™ Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, intervertebral disc space, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects created from traumatic injury to the bone. Mastergraft™ Granules provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, Mastergraft™ Granules must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

The Mastergraft™ Family of bone grafts in this submission includes Mastergraff™ Matrix EXT, Mastergraft™ Strip, Mastergraft™ Putty, and Mastergraft™ Granules. The devices all include osteoconductive biphasic calcium phosphate ceramic granules in different biocompatible physical forms supplied sterile for single patient use.

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 B-tricalcium phosphate formulation. Mastergraft™ Matrix EXT is supplied sterile in a premixed strip form for single patient use. Mastergrafi™ Matrix EXT 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. Mastergraft™ Matrix EXT is identical to the device cleared in K141824.

Mastergraff™ Strip is made from a combination of medical grade purified collagen of bovine origin 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 the device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. Mastergraft™ Strip is supplied sterile in a premixed strip form for single patient use. Mastergrafi™ 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™ Strip is identical to the device cleared in K082166.

Mastergraff™ 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 an 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 was shown to heal bone defects. Mastergraff™ Putty is identical to the device cleared in K071813.

Mastergraft™ Granules is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MASTERGRAFT® Granules is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Granules is an osteoconductive porous implant. Mastergraft™ Granules is identical to the device cleared in K082918.

The provided text is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML medical device.

The document discusses bone void filler devices (Mastergraft™ family) and their indications for use, stating that the current submission expands their use to include intervertebral disc space. The core of the notification is to establish that these devices are substantially equivalent to previously cleared devices. This is a regulatory pathway for medical devices that does not typically involve the kind of detailed performance studies with acceptance criteria, test sets, ground truth establishment, or clinical outcome measures that would be expected for a novel AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request using the provided text because it does not describe:

1. Acceptance criteria for device performance (in the context of an AI/ML device).
2. A study proving the device meets acceptance criteria. The document references prior clearances and robust analysis from previous studies, but it doesn't detail a new study design, methodology, or results related to specific performance metrics for the current submission.
3. Details about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. These are all concepts relevant to the validation of AI/ML models, which are not discussed in this medical device submission.

The "Performance" section explicitly states: "The subject devices have been previously cleared under K141824, K082166, K071813, and K082918, which serve as Reference Devices. These submissions are leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance as recommended in FDA's Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices. The device's performance in intervertebral spine was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies." This indicates reliance on previous data and general guidelines, not a new, specific performance study with the requested AI/ML validation metrics.

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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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MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are to be combined with autogenous bone marrow and are 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 or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix consist of a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation.

MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are supplied sterile in a premixed strip form for single patient use.

MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices are biocompatible, osteoconductive, porous implants that allow for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The devices readily absorbs bone marrow aspirate and had been shown to heal bone defects.

The purpose of this Special 510(k) application is to add additional sizes (known as MASTERGRAFT® UltraMatrix 5cc, 10cc, and 20cc) to the previously cleared MASTERGRAFT® Strip product family. The sizes proposed in this Special 510(k) were part of the original product design for MASTERGRAFT® Strip device, and were included in the design verification and validation activities reported in K082166.

The provided text is a 510(k) Summary for a medical device (MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one would for a novel device or AI.

The core of this document is a comparison to a previously cleared predicate device (MASTERGRAFT® Strip, K082166). The "study" here is essentially the non-clinical testing performed to show that the new device sizes (MASTERGRAFT® UltraMatrix 5cc, 10cc, and 20cc) are "substantially equivalent" to an existing, cleared device. This means the acceptance criteria are largely based on meeting recognized consensus standards for medical device materials, biocompatibility, and manufacturing, and showing that the new device has the same technological characteristics and performance as the predicate.

Here's an breakdown based on the information provided, keeping in mind the context of a 510(k) for a substantially equivalent device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document explicitly states: "The sizes proposed in this Special 510(k) were part of the original product design for MASTERGRAFT® Strip device, and were included in the design verification and validation activities reported in K082166." This indicates that the supporting data comes from the initial clearance of the predicate device (K082166). The document does not specify exact sample sizes for each non-clinical test mentioned, nor does it specify the country of origin of the data or if it was retrospective or prospective, beyond stating it was "non-clinical testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable in the context of this 510(k). This submission relies on non-clinical (laboratory/material) testing and comparison to a predicate device, not expert human assessment of diagnostic images or clinical outcomes that would require ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. The testing described is non-clinical (material characterization, biocompatibility, etc.) and does not involve human adjudication of results in the way a diagnostic study would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not describe an MRMC study. The device is a bone void filler, not an imaging or diagnostic AI device that would typically undergo such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

Not applicable. The product is a physical bone void filler, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is the established scientific and regulatory standards for medical device materials, biocompatibility, and performance, as well as the performance and characteristics of the legally marketed predicate device. This is primarily based on:

• Expert Consensus Standards: such as ASTM and ISO standards listed (e.g., ISO 10993 for biocompatibility, ASTM for material composition).
• Predicate Device Performance: The "truth" is that the new sizes of the device are identical in all critical aspects and therefore perform equivalently to the predicate (K082166), which has already been found safe and effective.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

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