(411 days)
Intended for use in filling bone voids or defects of the skeletal system (such as the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
CaP Plus is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, an inert carrier, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within the CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of CaP Plus osteoinductivity in humans.
The provided text is a 510(k) summary for the CaP Plus bone void filler and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria, performance metrics, and ground truth information as typically found in studies for diagnostic devices or AI algorithms.
Therefore, many of the requested fields cannot be directly extracted from the provided document. The device is a "bone void filler," which is a material implanted to aid bone healing, not a diagnostic or imaging device that would typically have acceptance criteria based on sensitivity, specificity, or AUC, nor "test sets" or "training sets" as these terms are used in the context of AI/ML performance evaluation.
Here's an attempt to answer the questions based solely on the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as would be expected for a diagnostic or AI-powered device. The basis of acceptance is "substantial equivalence" to predicate devices, meaning it shares the same function and intended use, and its safety and effectiveness are "adequately supported by the substantial equivalence data and testing results provided within this premarket submission." These "testing results" are not detailed in the provided summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics for device performance. The primary acceptance criterion for 510(k) devices is the demonstration of substantial equivalence to a legally marketed predicate device. This implies that the new device is as safe and effective as the predicate. | CaP Plus was found to be substantially equivalent to the predicate devices (CaP3 Bone Substitute Material, Optium DBM™ Gel & Putty, ALLOMATRIX® Putty, InterGro® DBM). It shares the same function and intended use. |
| (Implicit) Biocompatibility | CaP Plus is described as a biocompatible bone graft substitute material. |
| (Implicit) Resorption and Remodeling | CaP Plus resorbs and remodels during the healing process, consistent with its function as a bone graft substitute. |
| (Implicit) Osteoinductive potential (for DBM component) | Each lot of DBM within CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. (Note: The document states this "may or may not be predictive of CaP Plus osteoinductivity in humans"). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes a medical device (bone void filler) submission for regulatory clearance based on substantial equivalence, not a study evaluating an AI algorithm or diagnostic test on a "test set." The term "test set" is not used in the document. The document refers to "testing results" in the broader context of premarket submission data, but no specifics are provided regarding sample sizes for human or animal studies that might have been conducted to support biocompatibility or performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. There is no mention of a "test set" and thus no "ground truth" established by experts in the context of an AI or diagnostic study.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" or adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a bone void filler, not an AI or diagnostic tool. The document does not describe any MRMC studies or human reader performance with/without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
Not applicable in the context of AI/ML. For a bone void filler, the "ground truth" for performance would generally refer to histological evidence of bone ingrowth, successful fusion (if applicable), and resorption of the material, typically demonstrated in animal models or clinical studies. However, the document does not detail the specific studies or their "ground truth" outcomes. It only states that the safety and effectiveness are supported by "testing results." For the DBM component, "osteoinductive potential" as assayed in an athymic nude mouse model can be considered a form of "ground truth" for that specific characteristic.
8. The Sample Size for the Training Set
Not applicable. This document is not about an AI device or a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set."
§ 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.