(94 days)
OsteoSelect® DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony strtucture. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows: - Extremities . - Posterolateral spine - Pelvis
OsteoSelect® DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves. OsteoSelect® DBM Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.
The provided text describes a 510(k) summary for a medical device, OsteoSelect® Demineralized Bone Matrix Putty. It primarily focuses on demonstrating substantial equivalence to predicate devices based on manufacturing procedures, physical test results, shelf-life testing, functionality (efficacy testing), and biocompatibility.
However, the provided document DOES NOT contain information regarding:
- Acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy for an AI/algorithm).
- A "study" that proves the device meets these acceptance criteria in the context of an AI/algorithm for image analysis or diagnostics.
- Sample sizes for a test set or training set related to AI model evaluation.
- Details about ground truth establishment by experts, adjudication methods, or MRMC studies.
- Standalone performance (algorithm only) versus human-in-the-loop performance.
The "functionality (efficacy testing) results" mentioned refer to in vitro and in vivo biological tests for bone healing properties typical for a bone void filler, not an AI/ML diagnostic or predictive device. Specifically, it mentions:
- Viral inactivation potential: Evaluated with a panel of model viruses.
- Osteoinductive potential: Tested in an athymic rat model, with every final lot tested. The document explicitly states: "It is unknown how the osteoinductivity potential in the rat model correlates with human clinical performance."
- In vivo study: A report of an in vivo study was conducted to support use in the posterolateral spine. No details on this study's design, sample size, or outcomes are provided beyond its existence.
Therefore, it is not possible to fill out the requested table and answer the questions related to acceptance criteria and study proving device performance for an AI/ML device, as the provided text pertains to a traditional medical device (bone void filler) and not an AI/ML-driven product.
§ 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.