(32 days)
BF+ is indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine and the 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. BF+ is a bone graft substitute that resorbs and is replaced with bone during the healing process.
The BF+ is a synthetic, resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.
The provided text describes a 510(k) premarket notification for a bone void filler device named BF+. It focuses on establishing substantial equivalence to previously cleared devices rather than on performing a study to meet specific performance acceptance criteria for the device itself.
Therefore, many of the requested sections about acceptance criteria, study details, ground truth, and expert involvement are not applicable to the information given.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The provided documentation is a 510(k) summary for a medical device (BF+ Bone Void Filler) seeking clearance based on substantial equivalence to predicate devices, not based on meeting specific performance acceptance criteria derived from a novel study on the device's functional performance metrics. The clearance is based on equivalence in indications for use, design, material, and function, rather than quantitative performance against predefined thresholds.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. There is no mention of a "test set" in the context of device performance evaluation. The submission focuses on comparing the new device's characteristics to those of existing predicate devices.
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 test set or ground truth establishment by experts is described for this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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 device is a bone void filler, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical bone void filler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As the submission is for substantial equivalence, the "ground truth" is derived from the established characteristics and performance of the predicate devices. There is no new ground truth established for the BF+ device itself in this document.
8. The sample size for the training set
- Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
Summary of what the document does provide:
The document describes the BF+ as a synthetic, resorbable calcium phosphate bone void filler. Its characteristics are:
- Osteoconductive material
- Provides a porous scaffold for bone formation
- Interconnected porosity: 60-80%
- Pore size range: 200-500um
- Available in various shapes and sizes.
Its intended use/indications are:
- Filling bone voids or defects of the skeletal system (extremities, spine, pelvis)
- Defects are not intrinsic to the stability of the bony structure
- Defects may be surgically created or from traumatic injury
- Resorbs and is replaced with bone during healing.
The basis for FDA clearance is substantial equivalence to previously cleared predicate devices, based on equivalence in indications for use, design, material, and function. The FDA explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
§ 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.