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The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. The MTF New Bone Void Filler must be used in the posterolateral spine with bone marrow aspirate or autograft.

The MTF New Bone Void Filler is for single patient use only.

The MTF New Bone Void Filler (BVF) is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of BVF is not of animal origin. BVF comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent, such as blood and saline, can be used with BVF. Upon addition of a hydrating agent, BVF will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.

Here's an analysis of the provided text regarding the MTF New Bone Void Filler, focused on acceptance criteria and supporting studies:

It's important to note that this 510(k) submission is for a bone void filler, which is a medical device and not an AI/ML powered diagnostic or screening tool. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sensitivity, specificity, reader performance, ground truth establishment by experts, training set size, adjudication methods) are not applicable or described in this document.

The "acceptance criteria" for this device are focused on demonstrated substantive equivalence to predicate devices and meeting specific material properties and biological performance in animal models.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a numerical sample size in the context of typical "test sets" for AI/ML. The primary "test" to demonstrate substantial equivalence was an animal study. The document does not specify the number of animals or the design of this animal study.
• Data Provenance: The animal study is the key performance data. The document does not specify the country of origin but implies it was conducted to support FDA submission in the USA. It is a prospective study (for the animal model) designed to evaluate the new device.

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

• Not Applicable. For this bone void filler, "ground truth" as understood in AI/ML for image interpretation (e.g., disease presence/absence determined by human experts) is not relevant. The performance is assessed through biological outcomes in an animal model and adherence to material and processing standards.

4. Adjudication Method for the Test Set

• Not Applicable. No human-expert adjudication is described, as the evaluation method is not dependent on subjective human interpretation of diagnostic data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not an AI/ML powered diagnostic or screening device that uses human readers for interpretation. Therefore, a MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established through:
  • Biological Outcomes in an Animal Model: Specifically, osteoinductive potential in an athymic mouse model.
  • Material Properties Testing: Sterility (USP ), viral clearance and inactivation.
  • Compliance with Regulations: Donor suitability (21 CFR Part 1271).
  • Comparison to Predicate Devices: Demonstrating no new safety or effectiveness concerns based on the animal study.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML system that requires a "training set" in the computational sense.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Study Summary:

The primary study referenced to demonstrate the MTF New Bone Void Filler meets its acceptance criteria for substantial equivalence is an animal study. This study showed the new device was substantially equivalent to its predicate devices, implying similar safety and effectiveness profiles in that model. Additionally, routine lot release testing confirms osteoinductive potential in an athymic mouse model. Other "studies" or testing involve laboratory analyses for sterility, viral clearance, and adherence to regulatory standards for donor tissue processing.

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DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:

DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject Putty can be used as an extender in the spine with autograft. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

DBX® Inject is completely resorbable and is composed of donated cortical and cancellous bone. The bone granules are mixed with sodium hyaluronate (Hy). DBX® Inject consists of DBX Putty or Paste with a separate, sterile plastic syringe for delivery directly into the operative site.

The provided text is a 510(k) summary for the DBX® Inject device, a bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen in studies for diagnostic or AI-powered devices.

Therefore, the information required to populate the requested table and answer the study-related questions for a device performance study as described in the prompt is not present in the provided document. The 510(k) summary describes regulatory compliance, device characteristics, and comparisons to predicate devices.

However, I can extract information related to the device's biological potential and safety testing, which are forms of performance evaluation for this type of medical device.

Here's what can be gathered from the document, acknowledging the difference in scope from the prompt's implied request for clinical performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of a clinical study on device performance in humans. The testing mentioned is for lot release (biological properties) and viral inactivation.
  • For osteoinductive potential: "Every lot of final DBX® Inject Paste will be assayed," and "Every lot of final DBX® Inject Putty product will be tested." The specific number of samples per lot test is not provided, nor is the number of lots tested in the submission.
  • For viral clearance: A "panel of model potential human viruses" was evaluated. The specific number of virus types/samples used is not detailed.
• Data Provenance:
  • Osteoinductive potential: In vivo (athymic mouse model) and in vitro (alkaline phosphatase assay).
  • Viral clearance: In vitro (evaluated DBM processing methods).
  • Donor suitability: Refers to compliance with FDA regulations for human tissue donors.

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

• Not applicable. The ground truth here relates to biological activity (osteoinductivity) and viral inactivation, which are determined by laboratory assays and scientific protocols, not expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. This concept applies to human expert adjudication in clinical or diagnostic studies. The tests mentioned are laboratory-based.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., images), and the device aims to assist or improve their performance. DBX® Inject is a bone void filler, not a diagnostic device.

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

• No, a standalone performance study in the context of an algorithm or AI is not applicable. DBX® Inject is a physical medical device. The "performance" evaluated relates to its biological properties and manufacturing safety.

7. The Type of Ground Truth Used:

• Osteoinductive Potential: The "ground truth" is established by the qualitative result of the athymic mouse model (positive/negative for osteoinductivity) or the alkaline phosphatase assay, which is correlated to the mouse model. This is a scientific, biological assay result.
• Viral Clearance: The "ground truth" is the measured reduction/inactivation of various model viruses by the DBM processing methods. This is based on laboratory virology assays.
• Donor Suitability: Compliance with regulatory standards (21 CFR Part 1270 and Part 1271).

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The biological tests are on the final product lots.

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

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

In summary: The provided 510(k) summary for DBX® Inject addresses its safety and effectiveness through demonstrating substantial equivalence to predicate devices, biological activity (osteoinductive potential), and viral inactivation capabilities. It does not contain information on clinical trials with human subjects, device performance metrics, or reader studies that would typically apply to diagnostic or AI-powered devices. The "studies" described are primarily laboratory-based assessments of the product's inherent properties and manufacturing process safety.

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PROGENIX™ DBM Putty is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. When used in the extremeties or pelvis, the device is used by itself. When used in the spine, the device must be mixed with autograft bone and used as a bone graft extender.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX™ DBM Putty is a single use product intended for use as a bone graft substitute, bone graft extender, and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

Acceptance Criteria and Device Performance for Medtronic Sofamor Danek PROGENIX™ DBM Putty

This document describes the acceptance criteria and the study used to demonstrate the performance of the PROGENIX™ DBM Putty, as outlined in the provided 510(k) summary (K072265).

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the expanded indication of PROGENIX™ DBM Putty (use as a bone graft extender in spinal fusion procedures) were based on demonstrating its effectiveness in producing spinal fusion.

2. Study Design and Data Provenance

The study that demonstrated the expanded indication for PROGENIX™ DBM Putty was a rabbit study.

• Sample Size: Not explicitly stated in the provided text, but the study was conducted on a sufficient number of rabbits to "suggest that PROGENIX™ DBM Putty is effective."
• Data Provenance: The study was conducted in a pre-clinical animal model (rabbit). No country of origin is specified for the study location. The study is prospective as it evaluates the device's performance in a controlled environment.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not specify the number of experts used or their qualifications for establishing the ground truth of the rabbit study. However, the assessment of spinal fusion (radiographic and manual palpation) would typically involve trained veterinary radiologists and/or surgeons.

4. Adjudication Method

The adjudication method used for the rabbit study is not explicitly stated. However, given the nature of radiographic assessment and manual palpation, it is likely that the evaluation was performed by one or more trained individuals.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed as this is a pre-clinical animal study for a bone graft substitute, not a diagnostic imaging device.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a bone graft substitute, not an algorithm or software. Its performance is assessed through biological outcomes in vivo.

7. Type of Ground Truth Used

The ground truth used in the rabbit study was based on direct observation and objective assessments of fusion in an animal model:

• Radiographic criteria: Imaging evidence of spinal fusion.
• Manual palpation criteria: Physical assessment of spinal fusion.

8. Sample Size for the Training Set

Not applicable. This is a biological device, not an AI/ML algorithm that requires a training set. The "study" refers to the pre-clinical validation for the expanded indication.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

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