(209 days)
PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.
PLEXUR P is a bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as a bone void filler in bony voids or gaps of the skeletal system (i.e., extremities, pelvis) not intrinsic to the stability of the bony structure. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.
The provided text describes a 510(k) summary for the PLEXUR P bone void filler. This document is related to a medical device's regulatory approval process and includes performance data from animal studies. However, it does not describe an AI/ML device and therefore does not contain information typically associated with studies proving device performance against acceptance criteria for AI/ML models.
Based on the provided text, I can only extract the following relevant information:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain any explicit acceptance criteria in the format typically used for AI/ML device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, for this non-AI bone void filler, the performance is described in terms of its biological function.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified as a quantified criterion for this non-AI device) | "supports bone ingrowth and new bone formation." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: The text mentions "studies in animals" but does not specify the number of animals or the sample size used.
- Data provenance: "studies in animals" are mentioned, but no country of origin or whether the studies were retrospective or prospective is 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, as this is not an AI/ML device involving expert labeling for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring adjudication of expert labels.
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, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's function was observed through biological outcomes in animal studies, specifically "bone ingrowth and new bone formation." This could be considered a form of outcome data or histological observation in the context of biological research.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML 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.