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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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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. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.

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

The MTF New Bone Void Filler 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 the MTF New Bone Void Filler is not of animal origin. The MTF New Bone Void Filler 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 can be used with the MTF New Bone Void Filler. Upon addition of a hydrating agent, the MTF New Bone Void Filler 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.

The provided text does not contain detailed acceptance criteria, device performance data in a quantitative format, or descriptions of a study that would specifically prove the device meets such criteria in the manner typical of AI/medical imaging device submissions. The submission is for a "Bone Void Filler" and focuses on demonstrating substantial equivalence to predicate devices through material properties and in vitro or animal model testing, rather than human clinical trials with strict performance metrics.

Specifically, there is no mention of:

• A table of acceptance criteria with reported device performance for metrics like sensitivity, specificity, AUC, etc.
• Sample sizes for test sets (as there isn't a human clinical test set described in the context of device performance metrics).
• Data provenance for a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Sample size or ground truth establishment for a training set (as this is not an AI/machine learning device).

However, I can extract the information that is present and frame it in a way that aligns with the spirit of your request, interpreting "acceptance criteria" as implicitly tied to the demonstration of substantial equivalence and safety/effectiveness for this type of device.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Given that K110003 is a 510(k) premarket notification for a Bone Void Filler, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices, along with evidence of safety and effectiveness. This is achieved by comparing the new device's technological characteristics, intended use, and performance to those of the predicate.

The key study mentioned is an animal model study, and lot release testing, to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The primary "test set" in the context of demonstrating equivalence for this non-AI bone graft device is an in vivo animal study combined with in vitro testing.
• Sample Size: The specific sample size for the "Rabbit Model of Posterolateral Lumbar Fusion" study is not provided in the given text.
• Data Provenance: The study was conducted in a rabbit model, implying an animal study rather than human data. The geographical origin of the study is not specified, but it's presented by a US-based foundation (Musculoskeletal Transplant Foundation). It is inherently a prospective study if referring to the animal experimentation conducted to compare the new device to predicates.

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

• Number of Experts & Qualifications: This section is not applicable as the ground truth for an animal model study (e.g., fusion success, bone formation) would typically be established by veterinary pathologists, histologists, and/or radiologists specializing in animal models, not human medical experts in the context of clinical interpretation. The text does not provide these details.

4. Adjudication Method for the Test Set

• Adjudication Method: This is not applicable as the data presented is not based on expert interpretation of images or clinical outcomes in human subjects requiring an adjudication panel. Outcomes in an animal fusion model would typically be assessed objectively (e.g., imaging, histology, biomechanical testing).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret patient cases with and without AI assistance to measure reader performance improvement. This device is a bone void filler, not a diagnostic imaging AI.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No, a standalone performance study (algorithm only) was not done. This is also relevant for AI/machine learning algorithms. The device is a physical bone void filler.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For Osteoinductive Potential: The ground truth is established by positive results in an athymic mouse model (likely histological evidence of ectopic bone formation).
  • For the Rabbit Model of Posterolateral Lumbar Fusion: The ground truth for fusion outcomes would typically be based on a combination of radiographic evidence, CT imaging, and potentially histopathological analysis of explanted spines after a defined healing period. The specific details are not provided in the summary.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no AI/machine learning component, there is no training set or ground truth establishment for such a set.

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