(160 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 to be gently packed into bony gaps or voids in the skeletal system (extremities and pelvis). These defects may be surgically created or result from traumatic injury to the bone.
InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process. Testing has confirmed InQu™ is biocompatible as a bone void filler device. InQu™ is substantially equivalent to the predicate device in terms of material composition. technological characteristics and bone healing performance in an animal model.
This submission for the InQu™ resorbable bone void filler does not contain information on acceptance criteria or a study demonstrating the device meets such criteria in the context of device performance as would be expected for a diagnostic or AI-driven aid.
This is a traditional 510(k) submission for a medical device (resorbable bone void filler), not a software or AI-driven diagnostic device. Therefore, the typical performance metrics like sensitivity, specificity, or reader study results are not applicable, and the information requested in the prompt based on those types of studies will not be found in this document.
The submission focuses on substantial equivalence to a predicate device based on material composition, technological characteristics, and bone healing performance in an animal model.
Here's a breakdown of what information is available and why other requested information is not:
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Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, F-score) that would be expected for a diagnostic or AI device. The submission asserts substantial equivalence to a predicate device (PolyGraft™ BGS, OsteoBiologics, Inc., K040047) based on:
- Material composition: poly (D, L-lactide-co-glycolide) and hyaluronic acid.
- Technological characteristics.
- Bone healing performance in an animal model.
The document states: "Testing has confirmed InQu™ is biocompatible as a bone void filler device. InQu™ is substantially equivalent to the predicate device in terms of material composition, technological characteristics and bone healing performance in an animal model." However, no specific performance values or acceptance criteria for this animal model are provided in the excerpt.
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Sample size used for the test set and the data provenance: Not applicable. The "test set" in the context of an AI/diagnostic device is not relevant here. The evaluation mentioned is an "animal model," but the specifics of that study (e.g., number of animals) are not provided in this excerpt.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic image analysis (e.g., expert consensus on image findings) is not relevant to this type of device.
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Adjudication method: Not applicable.
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Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is not a diagnostic device intended for human reader assistance.
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Standalone performance study: Not applicable, as this is not a software algorithm.
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Type of ground truth used: For the bone healing performance, the "ground truth" would likely be based on histological analysis of bone formation or radiographic evidence of healing in the animal model. However, specific details are not provided.
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Sample size for the training set: Not applicable. This is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
Summary of available information related to performance/equivalence:
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Confirmed biocompatible as a bone void filler device. |
| Material Composition | Substantially equivalent to predicate PolyGraft™ BGS (composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid). |
| Technological Characteristics | Substantially equivalent to predicate. |
| Bone Healing Performance | Substantially equivalent to predicate in an animal model (resorbs and is replaced with bone during the healing process). Specific quantitative data from the animal model is not presented in this 510(k) summary. |
In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and results from standalone performance studies, which are typically found for diagnostic or AI-powered devices. The "study" mentioned is an "animal model" demonstrating bone healing performance and biocompatibility, but no detailed results or methodology are included within this excerpt.
§ 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.