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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® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include:

• o Filling of periodontal defects
• Filling of dental extraction sockets o
• Filling of cystic defects o
• o Sinus lifts
• o Alveolar ridge augmentation
• O Oral/maxillofacial augmentation or reconstruction.

MASTERGRAFT® Putty may be used with or without internal fixation, and maybe mixed with autograft as a bone graft extender.

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 that is 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. The product is biocompatible. MASTERGRAFT® Putty has been shown to heal bone defects.

The provided text describes a 510(k) premarket notification for a medical device called MASTERGRAFT® Putty. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MASTERGRAFT® Putty K081784) rather than presenting a study to prove new acceptance criteria or device performance against specific metrics.

Therefore, many of the requested categories for device performance studies are not applicable or cannot be extracted from this document, as the intent is not to qualify a new device with new performance claims, but to show that slight modifications to an existing device do not change its fundamental nature or performance.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable for this Submission Type)

The document does not specify new "acceptance criteria" in terms of performance metrics that a study would aim to meet for this specific submission. Instead, it asserts that the subject device's performance is "Identical" to the predicate device, implying it inherently meets the previously established criteria of the predicate.

Study Details (Focus on demonstrating equivalence, not new performance)

1. Sample size used for the test set and the data provenance:

   • Test Set Description: The document refers to "non-clinical testing" which included two animal studies. These studies were performed to assess the MASTERGRAFT® Putty but were not specifically described as "test sets" in the context of validating new acceptance criteria for this particular 510(k) submission's modification. Rather, they are part of the evidence supporting the general safety and effectiveness of the MASTERGRAFT® Putty product line to which this specific 510(k) is related. It's implied these studies supported the predicate device and are leveraged for equivalence.
   • Sample Sizes:
     • Two-month rabbit bilateral posterolateral spine fusion study: Sample size not specified.
     • Four-month sheep study: Sample size not specified.
   • Data Provenance: Not explicitly stated, but these are animal studies, likely conducted by the manufacturer or a contract research organization. The country of origin is not mentioned. They were prospective studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were animal studies evaluating biological responses (bone healing, ingrowth). Ground truth would be established through histological analysis, imaging, and biomechanical testing by veterinary pathologists and researchers, not expert consensus in the human imaging context typically seen with AI devices. No specific number or qualifications are provided here.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Animal studies typically involve objective measurements and histological assessments rather than adjudication by multiple human readers in the way clinical diagnostic studies do.

4. 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 document pertains to a bone graft material, not an AI or diagnostic imaging device that would involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal studies mentioned, the ground truth would typically be established through direct observation during necropsy, histopathology (microscopic examination of tissue samples), and potentially imaging (e.g., radiography, CT) or biomechanical testing to assess bone formation, fusion, and material resorption.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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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

MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include:

• . Filling of periodontal defects
• . Filling of dental extraction sockets
• . Filling of cystic defects
• . Sinus lifts
• . Alveolar ridge augmentation
• . Oral/maxillofacial augmentation or reconstruction.
  MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

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

This document is a 510(k) summary for Medtronic Sofamor Danek MASTERGRAFT® Putty, indicating its clearance for use in oral and oral/maxillofacial regions. It asserts substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, a direct response to your request, which expects explicit acceptance criteria and study results, cannot be fully provided from the given text.

Based on the information provided in the 510(k) summary:

• Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or provide a table of device performance against such criteria. The "acceptance" here refers to the FDA's determination of "substantial equivalence" to predicate devices, not meeting pre-defined performance metrics in a clinical study.
• Study Details (for a device proving equivalence): The document claims substantial equivalence based on comparisons to predicate devices (K071813, K010701, K030682, K062834, K051885).
  • Sample size used for the test set and data provenance: No specific test set sample size or data provenance is mentioned as this is a substantial equivalence claim, not a de novo clinical study with a test set.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts for a test set is typically part of a clinical trial or performance study, which is not detailed here.
  • Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The document does not describe MRMC studies or human reader improvement with AI assistance, as this device is a bone void filler, not an AI diagnostic tool.
  • If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a bone void filler product.
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for "substantial equivalence" is the established safety and effectiveness of the predicate devices. The document implies that data from previous clearances (K071813, K010701, K030682, K062834, K051885) was used to support this claim.
  • The sample size for the training set: Not applicable. This summary does not describe a training set for an algorithm.
  • How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The "study" in this context is the comparison demonstrating "substantial equivalence" to previously cleared predicate devices, not a clinical trial designed to establish specific performance metrics against acceptance criteria.

• MASTERGRAFT® Putty (K071813)
• MSD Biphasic Calcium Bone Void Filler (K010701)
• Calcium Hydroxylapatite Implant (K030682)
• Osteon (K062834)
• MBCP™ (K051885) |

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

MASTERGRAFT® Putty is made of medical grade combination of purified Type 1 bovine collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. When mixed with either autogenous bone marrow, and/or sterile water, and/or autograft the product forms into a putty, which is moldable. The product is supplied sterile for single patient use. 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. The product is biocompatible.

This is a 510(k) summary for a medical device (MASTERGRAFT® Putty), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance evaluation is not applicable.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, a regulatory pathway for medical devices that are similar to existing ones.

Here's a breakdown of what is provided in the document:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. This document does not define acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity) for an AI/ML system. The "acceptance" here refers to the FDA's regulatory acceptance of substantial equivalence.

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. There is no "test set" in the context of an AI/ML evaluation. The device is a bone void filler, and its equivalence is based on material composition, intended use, and similar design to existing products, not on data analysis for performance.

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 (e.g., expert-labeled data) is not relevant here. The evaluation relies on comparing the device's characteristics and indications to predicate devices.

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

• Not Applicable. No adjudication method for a test set is mentioned or relevant.

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 is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. The "ground truth" for this regulatory submission is essentially established by the FDA's existing regulations for medical devices and the characteristics of legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/ML product.

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

• Not Applicable. No training set exists.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" for this submission are the FDA's requirements for demonstrating substantial equivalence to legally marketed predicate devices. The "study" mentioned is the 510(k) premarket notification process itself, which involves providing documentation to the FDA to show this equivalence.

Key points from the document regarding substantial equivalence:

• Product Description: MASTERGRAFT® Putty is a combination of purified Type 1 bovine collagen, hydroxyapatite, and ß-tricalcium phosphate ceramic. It forms into a moldable putty when mixed with autogenous bone marrow, sterile water, and/or autograft. It is designed as an osteoconductive, porous implant that resorbs and is replaced by bone.
• Purpose of Application: To expand the indication for use with autograft as a bone graft extender.
• Indications for Use: Bone void filler for bony voids or gaps not intrinsic to bony structure stability, including use with autograft as a bone graft extender. Applied gently into skeletal system voids (e.g., posterolateral spine, pelvis, ileum, extremities), which can be surgically created or from traumatic injury. The device resorbs and is replaced by bone.
• Substantial Equivalence Documentation: The document states that "Documentation was provided which demonstrated MASTERGRAFT®Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K051386), MBCP™ (K051774), MASTERGRAFT® Matrix Resorbable Ceramic (K020986 and K012506), and to Orthovita's Vitoss Scaffold Foam Flow Bone Graft Material (K032288) and DePuy's HEALOS® Bone Graft Material (K043308 and K012751)."

The "study" here is the regulatory review of this documentation by the FDA. The FDA's letter (pages 2-3) confirms they have reviewed the 510(k) and determined the device is substantially equivalent for the stated indications, allowing it to be marketed.

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MasterGraft® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft® Matrix is to be combined with autogenous bone marrow and like MasterGraft® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices provide a bone void filler that resorbs and is replaced with bone during the healing process.

MasterGraft® Putty is made of medical grade combination of purified Type 1 bovine collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The ceramic portion of MasterGraft® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. When mixed with either autogenous bone marrow, and/or sterile water, and/or autograft the product forms into a putty, which is moldable. The product is supplied sterile for single patient use. MasterGrati® Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is blocompatible.

MasterGraft™ Matrix is made of medical grade combination of purified collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The collagen is a highly purified bioresorbable lyophilized bovine tendon that is primarily Type I collagen. The ceramic portion of MasterGrafi™ Matrix is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile in a premixed strip form for single patient use. MasterGraft™ Matrix is a 3-dimensional, ostcoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.

The purpose of this 510(k) application is to add the MasterGraft® Putty device to the previously cleared MasterGraft® product family.

This 510(k) premarket notification for Medtronic Sofamor Danek's MasterGraft® Putty and MasterGraft® Matrix provides information primarily focused on establishing substantial equivalence to previously cleared devices. It does not contain a study demonstrating the device's performance against specific acceptance criteria in the manner requested (e.g., clinical trial with quantitative performance metrics).

Therefore, I cannot populate the table or answer the questions related to acceptance criteria, sample sizes, expert ground truth, adjudication, or MRMC studies because the provided document does not contain this type of information.

The document states:

• "Documentation was provided which demonstrated MasterGraft® Putty to be substantially equivalent to the previously cleared MasterGraft® Matrix Resorbable Ceramic (K020986 and K012506), and to Orthovita's Vitoss Scaffold Foam Flow Bone Graft Material (K032288) and DePuy's HEALOS® Bone Graft Material (K043308 and K012751)."

This indicates that the regulatory pathway chosen was a substantial equivalence determination, not a clinical study to prove performance against pre-defined acceptance criteria for a new, novel device. The FDA's letter (K051386/S2) confirms this in its approval, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent to legally marketed devices..."

However, I can extract the following relevant information based on the request:

1. A table of acceptance criteria and the reported device performance

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

• This document does not describe a "test set" or a study with a defined sample size for evaluating the device against acceptance criteria. The submission is based on demonstrating substantial equivalence to existing predicate devices.

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

• This document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

• This document does not describe a study involving adjudication of a test set.

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

• No MRMC study was conducted or reported in this document. The device is a bone void filler, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device (bone void filler), not an algorithm or AI system.

7. The type of ground truth used

• Not applicable in the context of a performance study against acceptance criteria. The "ground truth" for this submission was the demonstration of substantial equivalence to legally marketed predicate devices based on a comparison of intended use, technological characteristics, and safety/effectiveness.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

• Not applicable as there is no training set for this type of device.

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