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HEALOS® FX Bone Graft Substitute ("HEALOS FX"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS® FX is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.

HEALOS® FX Bone Graft Substitute:

HEALOS® FX Bone Graft Substitute ("HEALOS® FX"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. The principal components of the HEALOS FX Bone Graft Substitute are Type I bovine collagen and hydroxyapatite that are resorbed and remodeled into new bone as part of the natural healing that are

HEALOS® FX Graft Mixing and Delivery System:

The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.

Acceptance Criteria and Study Details for HEALOS® FX Bone Graft Substitute and HEALOS® FX Graft Mixing and Delivery System

This submission pertains to the HEALOS® FX Bone Graft Substitute and its associated Graft Mixing and Delivery System. The provided documentation primarily focuses on establishing substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a standalone performance study with quantifiable metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, specific acceptance criteria with quantifiable metrics for the HEALOS® FX Bone Graft Substitute and the HEALOS® FX Graft Mixing and Delivery System are not explicitly stated. The submission relies on demonstrating substantial equivalence to existing predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size or data provenance for a distinct "test set" in the context of acceptance criteria. The performance evaluation mentioned for the HEALOS® FX Bone Graft Substitute likely refers to pre-clinical testing or comparative analysis with predicate device data, the details of which are not included in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. The submission focuses on substantial equivalence based on in vitro or in vivo studies (details not provided) rather than expert-derived ground truth on a specific test set.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the absence of a clearly defined "test set" and expert ground truth establishment, an adjudication method would not be applicable in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, as this device is a bone graft substitute and delivery system, not an AI or imaging diagnostic device where human reader performance would be a primary metric. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study for an algorithm was not conducted, as this device is a physical medical device (bone graft substitute and delivery system), not a software algorithm.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for the performance evaluation of the HEALOS® FX Bone Graft Substitute. Given its nature as a bone graft material, it is likely that performance was evaluated through in vitro biocompatibility tests, mechanical property assessments, and in vivo animal studies or clinical observations comparing bone regeneration and remodeling, which would eventually rely on histological analysis (pathology) or imaging (outcomes data) in the context of bone healing. However, these specifics are not detailed in the summary.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical device and not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical medical device and not an AI or machine learning model that requires a training set.

Summary of Device Performance Evaluation from the Document:

• HEALOS® FX Bone Graft Substitute: "A performance evaluation has been included to support the safety and effectiveness of HEALOS®FX compared to the predicate devices." (Detailed results of this evaluation are not provided in the 510(k) summary).
• HEALOS® FX Graft Mixing and Delivery System: "No performance standards have been established for this type of device. The substantial equivalence... is based upon equivalence in design, principles of operation, indications and intended use."

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