(244 days)
InQu® is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu® is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis) and as a bone graft extender in the spine when combined with bone autograft. 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.
InQu® Paste Mix Plus is intended for single patient use only. The device is a sterile, granular, synthetic bone void filler composed of poly (D,L-lactide-co-glycolide), hyaluronic acid and sodium carboxymethylcellulose provided in powder form, added to improve handling characteristics. The two components are mixed at the time of use and combined with a fluid (e.g. saline or blood) to form a putty, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.
The provided text describes a 510(k) premarket notification for the "InQu® Paste Mix Plus" device, which is a resorbable bone void filler. However, it does not contain a study that establishes acceptance criteria for performance metrics in the way typically seen for AI/ML-based devices with quantitative performance measures. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through material composition, technological characteristics, and dissolution rate.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this 510(k) submission for a medical device that is a bone void filler rather than a diagnostic or predictive algorithm.
Here's a breakdown based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
The provided text does not present explicit acceptance criteria or quantitative performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The study performed focuses on a comparative characteristic.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dissolution rate and characteristics not significantly different from predicate device granules | "The results show the two forms do not have significant differences." (referring to Paste Mix Plus vs. predicate device granules) |
| Substantially equivalent to predicate devices in terms of intended use, material composition, and technological characteristics | "The new device is substantially equivalent to the predicate devices in terms of intended use, material composition and technological characteristics, as shown in the above testing." |
2. Sample size used for the test set and the data provenance
The document mentions "a study comparing the dissolution rate and characteristics of the smaller granule size in the Paste Mix Plus to the granules in the predicate devices." No specific sample size for this study is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). This is a physical or chemical property test, not a clinical data test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is comparing physical/chemical properties (dissolution rate) of a bone void filler, not requiring expert consensus on clinical labels or image interpretations.
4. Adjudication method for the test set
Not applicable. This was a physical properties comparison study, not one requiring adjudication of clinical or image data.
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 bone void filler, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone void filler, not an AI/ML algorithm.
7. The type of ground truth used
For the dissolution rate study, the "ground truth" would be the measured dissolution rate and characteristics of the predicate device granules, against which the new device's granules were compared. This is a scientific measurement in a laboratory setting.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not 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.