(90 days)
HEALOS® Bone Graft Material (“HEALOS”), combined with autogenous bone marrow, is intended for use in filling bony voids 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 should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS® Bone Graft Material (HEALOS) is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of HEALOS are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight. The collagen is processed prior to mineralization using aqueous and organic purification steps to reduce lipids, salts, and endotoxins. Hydroxyapatite coats the surface of the collagen fibers by the controlled addition of calcium chloride, sodium phosphate, and sodium hydroxide. The mineralized collagen fibers are fixed into a three dimensional, open-cell matrix. HEALOS is provided as a sterile, dry material that must be hydrated with autogenous bone marrow at the point of use. HEALOS can be cut into shapes optimized for a specific population and is designed to retain its shape and physical integrity following specific population and is designed to simily resorbed during the natural process of bone formation and remodeling.
The provided text is a 510(k) summary for a medical device (HEALOS® Bone Graft Material) and describes its characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or the details of a study designed to prove the device meets those criteria, especially in the context of performance metrics like accuracy, sensitivity, or specificity that would be relevant for a diagnostic or algorithmic device.
The document outlines testing that was done, including material characterization, performance testing (pH measurement, solubility, in vivo testing in animal models, and clinical testing), but it does not provide the results of these tests against predefined numerical acceptance criteria. It only concludes that these tests "support the substantial equivalence of HEALOS Bone Graft Material to the predicate devices."
Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or multi-reader studies for a device performance evaluation in the way requested for an algorithmic/AI device.
Here's what can be extracted based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot provide. The document does not specify numerical acceptance criteria for various performance metrics (e.g., bone growth rate, resorption rate within a specific range, mechanical strength thresholds, etc.) nor does it report the device's performance against such criteria. It states that tests were performed (material characterization, in vivo, clinical) but only offers a general conclusion of "substantial equivalence."
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Cannot be determined from the document. The general mention of "in vivo testing (rabbit radial defect model, spinal fusion in any and fision solubinty, and in VIVO testing (intracutaneous toxicity; systemic toxicity; genotoxicity; cytotoxicity; sensitization; and bone implantation); and clinical testing" does not provide specific sample sizes for these studies.
- Data Provenance: The document implies in-house testing by Orquest, Inc. and references in vivo animal models (rabbit, "any" likely a typo for another animal or general reference) and "clinical testing", but no details on countries of origin or whether clinical data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot provide. The document does not describe the establishment of ground truth for any performance evaluation in terms of expert consensus or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot provide. This information is typically relevant for studies involving human interpretation or subjective assessment, which is not detailed here for performance evaluation.
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:
- No. This type of study is entirely irrelevant for a bone graft material. It's applicable to diagnostic or AI-assisted interpretation devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in vivo animal studies and clinical testing (general mention), the ground truth for evaluating the bone graft material would typically involve histological analysis (pathology) of new bone formation, radiographic assessment of defect healing, and possibly biomechanical testing or other clinical outcomes (e.g., patient reported outcomes, fusion rates for spinal applications). However, the document does not specify which of these were used or how they were established.
8. The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- N/A. Not an AI/ML 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.