(171 days)
Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-HA is intended to be gently packed 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 resorbs and is replaced with bone during the healing process.
Apatight-HA Bone Graft Substitute is a porous hydroxyapatite bone graft substitute for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile in block and granular forms. Apatight-HA Bone Graft Substitute guides the threedimensional regeneration of bone in the defect site into which it is implanted. When Apatight-HA Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.
This document is a 510(k) Pre-market Notification for a bone graft substitute, Apatight™-HA. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/CADe device. Therefore, much of the requested information regarding AI/CADe study design (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) is not applicable or cannot be extracted from the provided text.
However, I can extract the acceptance criteria and a description of the study used to claim equivalence for this medical device:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence):
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Intended Use Equivalence: Identical to the predicate device. | Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (extremities, spine, pelvis), including surgically created or traumatic defects. This matches the intended use of the equivalent predicate device. |
| Material Equivalence: Equivalent in materials to the predicate device and satisfies ASTM standards for implantable hydroxyapatite. | Apatight-HA is an osteoconductive porous hydroxyapatite bone graft substitute. The material satisfies an ASTM standard for implantable hydroxyapatite. The submission states the device is "identical in intended use and equivalent in materials and configuration to the predicate device" (Pro Osteon 500R Resorbable Bone Graft Substitute). |
| Configuration Equivalence: Equivalent in configuration to the predicate device. | Apatight-HA is a porous implant with a trabecular structure resembling human cancellous bone, provided sterile in block and granular forms. This configuration is stated to be equivalent to the predicate device. |
| Biocompatibility/Integration: Well-tolerated, completely integrated into the defect site, new bone growth, no inflammation or infection. This mirrors the expected performance of the predicate device for successful bone graft substitutes. | Results of performance testing in an animal model showed that the device was well-tolerated and completely integrated into the defect site. The interconnected porosity of the Apatight-HA implants was completely filled with new bone at the follow-up time points and there were no signs of inflammation or infection in any Apatight-HA treated animal. This indicates successful osteoconduction and host response as expected from the predicate device. |
Since this is a 510(k) submission for a bone graft substitute and not an AI/CADe device, the following points are largely not applicable or information cannot be extracted from the provided text.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document mentions "performance testing in an animal model," but does not specify the sample size of animals or their origin. It's a non-human biological study.
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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):
- N/A. Ground truth for animal model performance would typically be established by veterinary pathologists or histologists, but the number and qualifications are not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are relevant for interpreting human diagnostic imaging or clinical data, not typically for animal model histopathology unless multiple pathologists were involved in a blinded review (not specified here).
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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:
- N/A. This is not an AI device, so an MRMC study comparing human readers with AI assistance is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the animal study, the ground truth would be based on histopathology and observation of tissue integration (new bone formation, absence of inflammation/infection). The text states "completely integrated into the defect site" and "completely filled with new bone," which implies histological analysis.
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The sample size for the training set:
- N/A. There is no training set for an AI algorithm.
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How the ground truth for the training set was established:
- N/A. There is no training set for an AI algorithm.
§ 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.