(163 days)
ApaPore® is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. ApaPore® is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
ApaPore® is used in open bone voids that may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ApaPore® is intended for use on bone voids/gaps that are not intrinsic to the stability of the bony structure of the skeletal system, i.e., in the extremities, spine and pelvis.
ApaPore® is intended to be carefully packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine or pelvis). Following placement in the bony void. the synthetic bone void filler ApaPore® provides a scaffold for new mature host bone growth.
ApaPore® is phase-pure hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold. The interconnected and open porous structure of ApaPore® is similar to human cancellous bone. ApaPore® is available as irregularly shaped chips of 2 different sizes, in a choice of 3 porosities to suit surgeon preference.
The provided text is related to a 510(k) summary for a medical device called ApaPore® Bone Graft Substitute. It mainly focuses on asserting substantial equivalence to predicate devices and does not describe a study involving detailed acceptance criteria and reported device performance in the way one would expect for a diagnostic or AI-driven device.
Based on the provided text, here's a breakdown of the requested information, noting where details are unavailable:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" or "reported device performance" in terms of specific metrics like sensitivity, specificity, accuracy, or other performance characteristics. Instead, it relies on demonstrating compliance with relevant standards and clinical use.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document states, "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported," but this is a general statement about clinical use, not a structured test set with a defined sample size or detailed data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. The device is a bone graft substitute, and its evaluation relies on bench testing and clinical safety observations, not on expert ground truth for interpretation like a diagnostic imaging device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. There is no mention of an adjudication method as there is no diagnostic test set being interpreted.
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
This is not applicable as the device is a bone graft substitute, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical bone graft substitute, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and effectiveness claims, the "ground truth" seems to be established through:
- Bench Testing: "Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." This implies compliance with physical, chemical, and biological standards.
- Clinical Observation: "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported." This serves as real-world safety data.
- Biological/Physiological Outcome: The intended outcome is that the device "resorbs and is replaced by bone during the healing process" and "provides a scaffold for rapid bone repair via bony infiltration of the porous scaffolds." While detailed outcomes data from a specific study are not presented, these are the biological ground truths it aims to achieve.
8. The sample size for the training set
This is not applicable and not provided. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable and not provided. The device is not an AI algorithm that requires a training set with established ground truth.
Summary of Device Evaluation in the Document:
The provided 510(k) summary for ApaPore® Bone Graft Substitute primarily relies on:
- Substantial Equivalence: It claims substantial equivalence to predicate devices (Isotis NV OsSatura™ BCP Bone Void Filler) based on shared materials (porous calcium salt, hydroxylapatite), similar physical presentation (irregular granules/chips), and identical indications, contraindications, risks, and potential adverse events.
- Bench Testing: The document states that "Extensive bench testing has shown ApaPore® to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." While the specific standards and outcomes aren't detailed, this forms a basis for safety and performance claims.
- Clinical Experience (No Adverse Events): "ApaPore® has been regularly used clinically for the past 16 months and no adverse events have been reported." This provides real-world safety data, albeit not from a controlled clinical trial described here.
The document does not describe a clinical study with a defined test set, ground truth acquisition, expert involvement, or statistical analysis of performance metrics typically associated with diagnostic or AI-based devices. Its focus is on demonstrating safety and effectiveness for a Class II resorbable bone void filler through equivalence and compliance with established standards and observed clinical safety.
§ 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.