(254 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | No new types of safety and effectiveness questions | Demonstrated in the animal study provided to be substantially equivalent to predicate devices. |
| Osteoinductive Potential | Positive osteoinductive potential in athymic mouse model. | Positive in athymic mouse model. (Every lot tested for release.) |
| Biocompatibility/Material Properties | Made from biocompatible, biodegradable materials (demineralized human bone, gelatin, sodium hyaluronate). | Described as such, sodium hyaluronate not of animal origin. |
| Sterility | Aseptically processed and passes USP Sterility Tests. | Passes USP Sterility Tests. |
| Donor Suitability | Compliant with 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue Based Products). | Donor suitability criteria in compliance. |
| Viral Clearance and Inactivation | Demonstrated suitable viral inactivation potential for a wide spectrum of human viruses. | Testing demonstrated suitable viral inactivation potential. |
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.