(89 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). InQu is indicated for use 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 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) and hyaluronic acid. InQu is combined with a fluid (e.g. saline or blood) to form a paste, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.
Here's an analysis of the provided text regarding the acceptance criteria and study for the InQu® Paste Mix device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report and therefore does not contain the level of detail typically found in such reports regarding acceptance criteria, sample sizes, ground truth establishment, or clinical performance metrics like sensitivity, specificity, or reader studies. The "study" mentioned is a bench study, not a clinical trial.
Acceptance Criteria and Study Details for InQu® Paste Mix
Based on the provided K1118358 510(k) summary, the device is a resorbable bone void filler. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence (specifically, dissolution characteristics) to a previously cleared predicate device, rather than proving clinical performance against a set of predefined clinical metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Dissolution rate and characteristics of smaller granule size in Paste Mix should not have significant differences compared to granules in predicate devices. | The results show the two forms (smaller granule size in Paste Mix vs. granules in predicate devices) do not have significant differences in dissolution rate and characteristics. |
Explanation: This criterion is for a bench test comparing material properties. It is not a clinical acceptance criterion. The "reported device performance" is a direct statement of equivalence from the summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document refers to a "study comparing the dissolution rate and characteristics," but does not provide details on the number of samples or replicates used in this bench test.
- Data Provenance: The study was "performed" by ISTO Technologies, Inc. This would typically be a laboratory/bench study. There is no mention of country of origin for data as it's not a human-subjects study. It's a prospective bench test designed for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. This was a bench test evaluating material properties (dissolution rate and characteristics) under laboratory conditions, not a study requiring expert clinical interpretation or ground truth establishment in a human-subjects context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was a bench test for dissolution characteristics, there would be no need for clinical adjudication. The assessment would likely involve objective measurements and statistical comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document describes a bench study comparing material properties, not a clinical study involving human readers or cases to assess diagnostic or treatment effectiveness.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)
- Was a standalone study done? No. This device is a resorbable bone void filler, not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the traditional sense of clinical ground truth (e.g., pathology, outcomes data). For the bench study, the "ground truth" or reference was likely the established behavior/characteristics of the predicate devices' granules, measured objectively in a laboratory setting. The comparison sought to confirm that the new device's granules exhibited similar dissolution properties.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The study described is a bench test.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of 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.