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Orthocon AHBPpress™ Absorbable Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

Orthocon AHBP™ Absorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, water soluble and absorbable material of putty-like consistency intended for use in the control of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The material is a mixture of alkylene oxide polymer-based materials and carboxymethylcellulose sodium salt. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application.

When applied manually to surgically incised or traumatically broken bone, AHBP™ Absorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and substantially absorbed within a period of 8 days.

Here's a breakdown of the acceptance criteria and study information for the Orthocon AHBPpress™ Absorbable Hemostatic Bone Putty, based on the provided text.

Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results for novel devices. Therefore, detailed acceptance criteria and specific study outcomes are presented in a manner typical for such submissions, which often relies on bench testing and animal studies.

Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence, meaning the new device (AHBPpress™) performs similarly to the predicate device (AHBP™). The acceptance criteria are implicitly tied to matching the predicate's performance in key areas and meeting general biocompatibility and safety standards.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated in terms of specific numbers for each bench or animal study. The document mentions "testing was conducted" and "animal studies to demonstrate," implying sufficient samples were used to generate the necessary data for a 510(k) submission.
• Data Provenance: Not specified. Standard practice for such submissions would be studies performed in a certified laboratory (for bench tests) or animal facility. The document does not indicate country of origin or whether studies were retrospective or prospective, though animal studies would inherently be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is not a study requiring expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for the bench and animal studies would be the objective measurements and observations made by laboratory personnel or veterinarians, adhering to study protocols.

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

• Not applicable. This is not a study requiring human adjudication of results in the way a clinical trial for diagnostic accuracy might. The outcomes of the bench and animal studies are typically direct measurements or observations.

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 is not a diagnostic device or an AI-assisted device. Therefore, MRMC studies and the concept of human reader improvement with AI are not relevant.

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

• No. This is a medical device (hemostatic bone putty), not a software algorithm.

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

• Bench Studies: Objective measurements of physical properties (smearability, stiffness, dissolution rate, swelling, temperature sensitivity).
• Biocompatibility Studies: Established biological endpoints and observations based on ISO 10993 standards (e.g., cell viability for cytotoxicity, tissue reaction for implantation).
• In Vivo Performance Studies (Animal): Direct observation of hemostasis, resistance to irrigation, ease of removal, and histological or gross assessment of absorption time and safety in animal models.

8. The sample size for the training set

• Not applicable. This device does not use an algorithm that requires a training set.

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

• Not applicable. This device does not use an algorithm that requires a training set.

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