(89 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. It can be used in the pelvis and extremities. The MTF New Bone Void Filler can be used as an extender in the pelvis and extremities with autograft or allograft. The MTF New Bone Void Filler can be used with bone marrow aspirate, blood or saline.
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 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 describes the MTF New Bone Void Filler and its substantial equivalence to predicate devices, focusing on safety and effectiveness information rather than specific acceptance criteria from a clinical study for device performance. It emphasizes the osteoinductive potential demonstrated in an athymic mouse model, but explicitly states that the correlation with clinical performance in human subjects is unknown.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be found in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoinductive potential (in athymic mouse model) | Must prove positive for lot release (standard testing performed in an athymic mouse model). |
| Sterility (USP ) | Aseptically processed and passes USP Sterility Tests. |
| Viral Clearance/Inactivation | Demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices in the animal study provided within this submission. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any study mentioned.
- Data Provenance: The primary "study" mentioned for establishing osteoinductive potential is an "athymic mouse model." This indicates an animal study. No human data (retrospective or prospective) is described for device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for osteoinductive potential was based on observations in the athymic mouse model and for sterility on standard USP testing. The concept of expert consensus for ground truth as typically understood in diagnostic studies is not relevant here.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The evaluations mentioned (e.g., osteoinductive potential in mice, sterility testing) are objective tests, not subjective interpretations requiring adjudication.
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:
- MRMC Study: No. This device is a bone void filler, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a medical device (bone void filler), not an algorithm. The concept of standalone algorithm performance does not apply.
7. The type of ground truth used:
- Ground Truth for Osteoinductive Potential: Positive result in an athymic mouse model (animal study observation).
- Ground Truth for Sterility: Passing USP Sterility Tests (laboratory test result).
- Ground Truth for Viral Clearance: Demonstrated inactivation of model viruses (laboratory test result).
- Ground Truth for Substantial Equivalence: Comparison to predicate devices based on an "animal study" (details not provided) and material composition/intended use.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. The document describes a medical device, not a machine learning model that requires a training set. The "testing" referred to is for lot release and safety/equivalence rather than machine learning model development.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned for a machine learning model.
§ 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.