(221 days)
Pioneer FortrOss Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Pioneer FortrOss Bone Void Filler is a porous calcium phosphate material mixed with a porcine gelatin carrier. The product is an osteoconductive scaffold mixed with a gelatin carrier for use in repairing bony defects in spinal indications.
The provided text is a 510(k) summary for the Pioneer FortrOss Bone Void Filler. This document describes the device, its intended use, and its substantial equivalence to other marketed devices. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way typically found for medical imaging or diagnostic AI devices.
The 510(k) process for devices like bone void fillers primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against quantitative acceptance criteria through a specific clinical study with established ground truth, specific sample sizes, or expert adjudication as one would for an AI diagnostic tool.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This type of data is not required for a 510(k) submission for a bone void filler focusing on substantial equivalence. Performance is typically demonstrated through bench testing and comparison to predicates.
- Sample sizes used for the test set and the data provenance: Not relevant in this 510(k) context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant.
- Adjudication method for the test set: Not relevant.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not relevant as this is a medical device (bone void filler), not an AI diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not relevant.
- The sample size for the training set: Not relevant as there is no mention of a "training set" in the context of an AI/ML model for this device.
- How the ground truth for the training set was established: Not relevant.
The primary "proof" of the device meeting acceptance criteria in a 510(k) for a bone void filler comes from:
- Demonstrating "substantial equivalence" to legally marketed predicate devices. The text states: "The comparisons and testing conducted on FortrOss Bone Void Filler demonstrate that the device is substantially equivalent to other bone void fillers currently in commercial distribution." This substantial equivalence is based on similar composition, performance characteristics (presumably assessed through bench testing and material properties), and intended use.
- Meeting the general controls and special controls for Class II devices. These are regulatory requirements that all such devices must satisfy, including aspects like good manufacturing practices (GMP), labeling requirements, and any specific performance standards defined for the product code MQV (Resorbable calcium salt bone void filler device).
The study that proves the device meets acceptance criteria, in this context, is the 510(k) submission itself, which presents evidence (likely bench testing, materials characterization, and literature review) to support its substantial equivalence claim. No specific "study" with a "test set," "ground truth," or "expert adjudication" as defined in the prompt (which is typical for AI/ML device evaluations) is detailed because this is not an AI diagnostic 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.