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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® 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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