(79 days)
Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a Bone Void Filler that resorbs and is replaced with bone during the healing process.
Osteofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Filler.
The provided text is for a medical device called "Osteofix™ Bone Void Filler." The documentation focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a specific study with performance metrics for the device, or details about ground truth, expert involvement, or sample sizes as one might find for a software or AI-based diagnostic device.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The overarching criteria seem to be related to safety, effectiveness, and substantial equivalence to predicate devices. | "Results demonstrated substantially similar rates of resorption [compared to Pro Osteon 500R]." |
| "Results of bench testing demonstrate that Osteofix™ Bone Void Filler meets its specifications and does not raise new issues of safety or effectiveness." | |
| "In all instances, Osteofix™ Bone Void Filler functioned as intended." | |
| "The materials [in Osteofix™] were biocompatible." | |
| "Osteofix™ Bone Void Filler is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "a single comparison study" but does not give the number of samples or subjects.
- Data Provenance: Not specified, but likely pre-clinical (bench testing) and possibly animal studies, given the nature of the device (bone void filler). The study compared Osteofix™ to Pro Osteon 500R.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This type of information is typically for diagnostic devices where expert interpretation is crucial for ground truth establishment. For a bone void filler, the "truth" would likely be based on objective measures like resorption rates, material composition, and mechanical properties.
4. Adjudication method for the test set
- Not applicable/Not specified.
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
- Not applicable. This device is a physical bone void filler, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used
- The "ground truth" (or basis for comparison/evaluation) appears to be:
- Predicate Device Performance: Comparison to "Pro Osteon 500R" regarding resorption rates.
- Product Specifications: Demonstrated by bench testing.
- Biocompatibility: Established through testing (though specific tests aren't detailed).
- Intended Function: "functioned as intended."
8. The sample size for the training set
- Not applicable/Not specified. This concept applies more to machine learning models.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
§ 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.