(234 days)
MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse ™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
MicroFuse™ Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse™ is available with and without calcium sulfate. MicroFuse™ is provided in a variety of shapes and sizes, in the form of granules, sheets, and pre-formed blocks. MicroFuse™ granules are designed to be gently packed into contained voids or defects. MicroFuse™ sheets are designed to be used with shallow bony defects, or as a bone graft only to cover a defect. MicroFuse™ blocks are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.
This document is a 510(k) premarket notification for the MicroFuse™ Bone Void Filler. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in the way one would typically describe for a diagnostic AI device or a device with measurable performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the basis for clearance is substantial equivalence to existing legally marketed predicate devices, meaning it is considered as safe and effective as those already approved. The FDA's letter explicitly states that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
Therefore, I cannot provide the requested information in the format of a table demonstrating acceptance criteria and reported device performance for an AI/diagnostic device, nor details about sample sizes, ground truth establishment, or MRMC studies, as these aspects are not present in the provided text for a bone void filler product cleared via substantial equivalence.
I will, however, extract and summarize the relevant information as best as possible based on the nature of this submission.
1. Table of Acceptance Criteria and Reported Device Performance
As this device (MicroFuse™ Bone Void Filler) is a medical implant cleared via the 510(k) pathway based on substantial equivalence, there are no explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, or accuracy) in the provided text, nor a study demonstrating such performance for a diagnostic or AI device. The "performance" is implicitly deemed acceptable by its similarity to predicate devices.
| Acceptance Criteria (Not explicitly stated for performance metrics) | Reported Device Performance (Implicitly deemed acceptable via Substantial Equivalence) |
|---|---|
| Safety and Effectiveness (Implied by 510(k) pathway) | The device is substantially equivalent to legally marketed predicate devices with respect to design, indications for use, principles of operation, and performance. |
| Intended Use Fulfilled | Intended for use in filling bony voids or gaps of the extremities and pelvis; resorbs and is replaced with bone during the healing process. |
| Biocompatibility/Material Properties | Composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres, with or without calcium sulfate. (Implicitly meets safety standards). |
| Resorption and Bone Replacement | "[The device] provides a bone void filler that resorbs and is replaced with bone during the healing process." |
2. Sample Size for Test Set and Data Provenance
Not applicable. This is a 510(k) premarket notification for a medical implant, not a study evaluating the performance of an AI or diagnostic device using a test set of data. The submission relies on demonstrating substantial equivalence to predicate devices, which typically involves comparing device specifications, materials, and intended uses, rather than a clinical trial with a "test set" of patients for performance evaluation in the context of AI.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic or AI performance studies. This document does not concern such a study. The "ground truth" for a bone void filler is its functional performance in vivo, which is assessed through a combination of existing clinical knowledge, preclinical testing, and comparison to predicate devices, rather than expert consensus on diagnostic images.
4. Adjudication Method
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations in diagnostic studies. This document does not describe such a study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned or implied, as it is a common study design for evaluating the impact of AI on human reader performance in diagnostic imaging. This device is a bone void filler, not a diagnostic tool or AI algorithm.
6. Standalone (Algorithm Only) Performance Study
No. The MicroFuse™ Bone Void Filler is a physical implant, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" in the context of this 510(k) submission is the established safety and effectiveness of the predicate devices and the expectation that the MicroFuse™ Bone Void Filler, due to its similar design, materials, and intended use, will perform comparably. This is based on a combination of:
- Existing clinical evidence/regulatory history of the predicate devices.
- Material science data demonstrating the properties of the MicroFuse™ components.
- Preclinical (e.g., animal) studies if conducted (though not detailed in this summary).
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained, so there is no training set sample size.
9. How the Ground Truth for the Training Set was Established
Not applicable. Again, there is no AI algorithm and therefore no training set with associated ground truth for establishment.
§ 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.