(203 days)
BF+ (Ph) resorbable void filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis), caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BF+ (Ph) is a bone graft substitute that resorbs and is replaced with bone during the healing process.
The BF+ (Ph) system is manufactured using 100% tricalcium phosphate [Ca3(PO4)2]. BF+ (Ph) is a bone graft substitute that resorbs within 6-12 months and is replaced with bone during the healing process. The cube, granule, stick, and block forms are intended to allow for a full range of surgeon preference, and provide a multidirectional interconnected porosity structure similar to that of human cancellous bone. Density for cubes and granules range from 1.228 to 1.842 g/cm³, and from 1.535 to 1.842 g/cm³ for sticks and blocks.
The provided text is a 510(k) summary for the BF+® (Ph) Bone Void Filler. This document describes a medical device and its equivalence to a predicate device, as required for FDA clearance. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way a diagnostic AI would be evaluated.
Here's why the requested information cannot be extracted from this document, and what the document does say:
- Nature of the Device: The BF+® (Ph) is a bone void filler, a physical product intended to fill gaps in bones. It's a bone graft substitute. It is not an AI/ML diagnostic device, imaging system, or software that generates data or provides analysis based on input.
- Regulatory Pathway: This is a 510(k) premarket notification. For devices cleared via this pathway, the primary demonstration is "substantial equivalence" to a predicate device already on the market. This often relies on comparing material properties, intended use, and existing safety/performance data of the predicate, rather than new, extensive clinical studies with specific performance criteria for the new device itself.
- Content of the Document: The document explicitly states: "Mechanical testing of the LDR Spine USA BF+® (Ph) device was not performed, as the materials, processes and supplier are identical to that of the predicate BIOSORB® Resorbable Bone Void Filler manufactured by SBM France (Premarket Notification K021963)." This confirms that a stand-alone, new performance study for this specific device was not conducted to establish new performance metrics.
Therefore, since the device is a physical bone void filler and its clearance was based on substantial equivalence to a predicate without new mechanical testing for this device, the requested information (acceptance criteria, details of a performance study, sample sizes, expert ground truth, MRMC, standalone performance, etc.) is not present in this document.
To directly answer your request based on the lack of this information in the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable as this is a 510(k) for a physical bone void filler, not an AI/ML diagnostic device. No specific acceptance criteria or performance metrics (like sensitivity, specificity, AUC) are reported for this device's performance in a study. Its functional performance is considered substantially equivalent to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No test set or clinical study data for device performance is mentioned as "Mechanical testing of the LDR Spine USA BF+® (Ph) device was not performed."
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 no test set or ground truth establishment relevant to an AI/ML device is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no test set or adjudication process is mentioned.
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 is a physical bone void filler, not an AI-assisted diagnostic tool for human readers.
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. The document states mechanical testing was not performed for this device, relying instead on the predicate.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is established for this device as it is not an AI/ML or diagnostic device.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment is mentioned.
In summary, the provided document describes a regulatory submission (510(k)) for a physical medical device (bone void filler) where clearance was based on substantial equivalence to a predicate device, rather than new, independent performance studies for the device itself. Therefore, the information you're asking for, which is typically relevant for AI/ML or diagnostic devices, is not present here.
§ 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.