(356 days)
AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. It is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. AFT is for single patient use only.
AFT is composed of human demineralized bone matrix, human nondemineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
The provided text describes the regulatory clearance of a bone void filler and does not contain information about acceptance criteria, device performance, or human-AI comparative effectiveness studies. It focuses on demonstrating substantial equivalence to predicate devices based on safety, biocompatibility, osteoinductivity potential in an animal model, and viral inactivation processes.
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided document.
Here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The text highlights "osteoconductive" and "osteoinductivity potential in an athymic mouse" as performance characteristics, but no specific quantitative acceptance criteria or detailed performance metrics are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of submission. The "test set" mentioned refers to in vivo testing in an athymic mouse model, but sample size, country of origin, or whether it was retrospective/prospective are not specified.
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)
Not applicable. No human experts were used to establish ground truth for the device's performance in the context of this regulatory submission. Animal model results were presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not a description of an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "osteoinuductivity potential" was established through "in vivo testing in the athymic mouse model." This animal model serves as the "ground truth" for demonstrating the material's ability to support new bone growth.
8. The sample size for the training set
Not applicable. This is a medical device (bone void filler), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.