(43 days)
Vitoss® Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
This submission describes a bone graft substitute (Vitoss Bioactive Foam), not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and performance data from in vitro studies.
Here's an attempt to address the relevant points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness substantially equivalent to predicates | "Vitoss Bioactive Foam is as safe and effective as its predicates." "The minor differences between Vitoss Bioactive Foam and its predicate devices raise no new issues of safety or effectiveness." "Performance data demonstrate that Vitoss Bioactive Foam is as safe and effective as its predicate devices." |
| Osteoconductivity | "Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone." |
| Osteostimulatory properties (in vitro) | "Vitoss Bioactive Foam is osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. The Vitoss Bioactive Foam strips had widespread calcium phosphate formation by 3 days. This phenomenon was not observed in control samples in which there was no bioactive glass component." |
| Function as intended | "Performance testing was conducted to ensure that Vitoss Bioactive Foam met its design requirements and performed in a manner substantially similar to the predicate devices. In all instances, Vitoss Bioactive Foam functioned as intended." |
| Resorption and replacement with bone | "Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process." (This is part of the Intended Use, implying it's an expected outcome, but direct performance data on the rate/extent of human resorption is not provided in this summary. It's likely inferred from the predicate devices and the material's properties.) |
| Suitable for intended use as a bone void filler | "Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure... for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis)." (This is the indication for use, supported by the other performance data and substantial equivalence argument.) |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A) for an AI/ML device.
- The "performance testing" mentioned refers to in vitro studies. No specific sample sizes for these in vitro tests (e.g., number of strips, number of simulated body fluid trials) are provided in this summary.
- The data provenance is from in vitro studies, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A for an AI/ML device.
- Ground truth for material properties (e.g., calcium phosphate formation) would be established by standard laboratory analytical methods, not human expert consensus in the context of clinical images.
4. Adjudication method for the test set
- N/A for an AI/ML device.
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
- N/A. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI algorithm.
7. The type of ground truth used
- The ground truth for the in vitro performance data (osteostimulatory properties) was based on laboratory measurements/observations of calcium phosphate formation in a simulated body fluid, as observed by standard analytical techniques.
8. The sample size for the training set
- N/A for an AI/ML device.
9. How the ground truth for the training set was established
- N/A for an AI/ML device.
§ 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.