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HEALOS Bone Graft Material ("HEALOS"), 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 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 process.

Addition of dimensional and volumetric configurations to the HEALOS Bone Graft Material

This FDA 510(k) K043308 document for the HEALOS® Bone Graft Material is a premarket notification for a Class II medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (K012751).

Crucially, this type of submission (510(k) for a bone graft material) typically does not involve the kind of performance studies or acceptance criteria that would utilize algorithms, AI, or human readers in the way your detailed request implies.

Here's a breakdown of why your specific questions about acceptance criteria, study design, multi-reader multi-case studies, and ground truth for AI models are not directly applicable to this document:

• Device Type: The HEALOS Bone Graft Material is a physical medical device (filler, calcium sulfate preformed pellets) for bone void filling, not a diagnostic imaging device or an AI-powered diagnostic/assistance tool.
• 510(k) Process: A 510(k) aims to establish substantial equivalence. For a device like this, the "performance data" referred to (if any) would typically involve biocompatibility testing, material characterization, mechanical properties, and perhaps animal studies to show resorption and new bone formation. It would not involve a "device performance" in terms of diagnostic accuracy or a human-AI interaction study.
• "Performance Data" Section: The document explicitly states: "PERFORMANCE No performance standards have been established for DATA: this type of device." This further reinforces that there are no pre-defined quantitative or qualitative metrics for "device performance" in the sense of diagnostic accuracy that would be assessed in a clinical trial with human readers or AI.

Therefore, most of your requested information cannot be extracted from this document because it pertains to types of studies and evaluations that are not relevant to a 510(k) for a bone graft material.

However, I can address the spirit of some of your questions based on what might be implied by the substantial equivalence process for such a device, and explicitly state what is missing.

Acceptance Criteria and Study for HEALOS® Bone Graft Material (K043308)

Based on the provided K043308 document for HEALOS® Bone Graft Material, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic device is not applicable. This submission is for a physical bone graft material seeking Substantial Equivalence (SE) to a predicate device. The "acceptance criteria" here would implicitly relate to demonstrating safety, effectiveness, and substantial equivalence to the predicate device, often through material characterization, biocompatibility, and potentially animal studies, rather than performance metrics for an algorithm or diagnostic accuracy.

Information Not Found (and why):

Most of the requested information (points 1-9) relates to the evaluation of AI/diagnostic algorithms. This 510(k) is for a physical bone graft material, and therefore, these types of studies were not conducted or reported in this document.

Detailed Response to Your Specific Questions in the Context of a Bone Graft Material 510(k):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity/specificity for a diagnostic device. For a bone graft material 510(k), acceptance criteria implicitly revolve around demonstrating substantial equivalence to the predicate device (HEALOS Bone Graft Material K012751) in terms of materials, intended use, and general safety/effectiveness characteristics. This would involve showing similar biocompatibility, resorption profiles, and mechanical properties.
   • Reported Device Performance: The document states: "PERFORMANCE No performance standards have been established for DATA: this type of device." This means there aren't quantitative performance metrics like those for diagnostic devices reported here. Performance would be inferred from material characterization and comparison 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):

   • Not Applicable: This type of test set is relevant for diagnostic or AI algorithm evaluation, not for a bone graft material device. Data provenance (country, retrospective/prospective) would be for clinical data, which is not detailed in this 510(k) for a physical device. Any "testing" would be laboratory-based (material, mechanical) or potentially animal studies, not human subject test sets in the diagnostic sense.

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: Ground truth for a test set (e.g., disease presence) is not relevant for a bone graft material device. This question applies to diagnostic evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable: Adjudication methods are used to establish a consensus ground truth for diagnostic decisions, which is irrelevant for a bone graft material.

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: MRMC studies and the concept of "human readers improving with AI assistance" are specific to diagnostic support systems incorporating AI. This device is a physical bone graft material.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable: "Standalone algorithm performance" is not relevant as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not Applicable: The concept of "ground truth" in this context is for diagnostic confirmation. For a bone graft material, "ground truth" in a very loose sense might refer to histological evidence of bone formation in an animal model or mechanical testing results meeting specifications, but not in the diagnostic sense.

8. The sample size for the training set:

   • Not Applicable: "Training set" is a concept for machine learning algorithms. This device is a physical product.

9. How the ground truth for the training set was established:

   • Not Applicable: As with training sets, establishing ground truth for them is an AI/ML concept, not relevant to a bone graft material.

In summary, the K043308 document demonstrates substantial equivalence for a bone graft material by comparing it to an existing predicate device, primarily focusing on materials, safety, and intended use. It does not involve the type of performance studies, acceptance criteria, or evaluation metrics that would be used for an AI-powered diagnostic device, and therefore, the information requested in your specific questions is not present in this document.

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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.

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