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Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Synthes Hemostatic Bone Putty (HBP) stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during the surgical procedure. When applied as directed, HBP forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure and dissolves postoperatively, permitting normal tissue healing and bone regeneration. HBP is a blend of synthetic water soluble polymers that form a ready-to-use hemostatic agent that is substantially eliminated from the defect site in less than 48 hours. The constituents of Synthes Hemostatic Bone Putty and Ostene, the predicate, are similar. Ostene is comprised of a proprietary mixture of water soluble alkylene oxide copolymers. HBP is also comprised of water soluble alkylene oxide polymers. The remainder of HBP is a polysaccharide, carboxymethylcellulose (CMC), to improve handling. Ostene does not contain CMC.

The provided text describes a 510(k) submission for the Synthes Hemostatic Bone Putty (HBP) and mentions a variety of non-clinical tests performed for substantial equivalence comparison. However, it does not contain the detailed acceptance criteria or numerical performance data of the device in a structured table, nor does it present a study proving the device meets specific performance criteria.

The document primarily focuses on establishing "substantial equivalence" of HBP to a predicate device (Ostene CT Soluble Hemostasis Implant Material, K082491), rather than demonstrating direct performance against predefined acceptance criteria. Substantial equivalence in this context means the device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested sections regarding acceptance criteria, reported performance, sample sizes, ground truth, and expert involvement cannot be extracted directly from this document.

Here's what can be inferred or stated based on the provided text, while also explicitly noting what is not available:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document lists several non-clinical tests that were performed, but it does not specify quantitative acceptance criteria for these tests or present the reported numerical performance of the device against such criteria. The studies listed are:

• Cytotoxicity Study Using the ISO Elution Method
• Mouse Peripheral Blood Micronucleus Study
• ISO Modified Intracutaneous Study, Solution with Measurement
• Genotoxicity: Bacterial Reverse Mutation Assay
• Genotoxicity: Mouse Lymphoma Assay
• ISO Guinea Pig Maximization Sensitization Test-Solution
• Systemic Toxicity Study
• An In Situ Study to Determine the HBP Resorption Rate in a Rat Craniotomy Model
• In Vivo Resorption Rate of a Hemostatic Bone Putty Subcutaneously Implanted in the Rabbit at 2, 4, 7, 14 Days.
• In Vivo evaluation of Hemostatic Bone Putty in a sheep vertebral body defect at 7 days
• Evaluation of Hemostatic Bone Putty in a Sheep Vertebral Body Defect
• An In Vivo Study to Determine Hemostatic Bone Putty Effect on Bone Healing In A Rat Craniotomy Model at 3, 6, and 12 Weeks

The document states that "Documentation is provided that demonstrates that Synthes Hemostatic Putty is substantially equivalent' to other legally" marketed devices. This implies that the results of these tests were considered satisfactory to demonstrate equivalence, but the specific performance outcomes or the acceptance thresholds are not detailed.

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

The document lists several in vivo and in vitro animal studies.

• Animal Models Used: Rat, Rabbit, Sheep.
• Sample sizes for these studies are not specified in the provided text.
• Data Provenance: Not explicitly stated, though the applicant is Synthes USA Products, LLC, with an address in West Chester, PA, USA. The studies likely originated from contract research organizations or internal labs, but the specific country of origin for the data is not mentioned.
• Retrospective or Prospective: These would be prospective animal studies, as they involve active experimentation to test the device.

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

This information is not applicable as the evaluation is for a physical medical device (hemostatic bone putty) through non-clinical (animal and lab) studies, not a diagnostic AI device requiring expert consensus or ground truth derived from human interpretation. The "ground truth" would be the biological and physical measurements and observations from the animal models, analyzed by researchers/pathologists. The specific qualifications of those interpreting the animal study results are not provided.

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

This is not applicable to the non-clinical studies described, which are not based on human-in-the-loop diagnostic interpretations. The evaluation relies on laboratory and in vivo observation methods.

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:

This is not applicable. The device is a hemostatic bone putty, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

This is not applicable. The device is a hemostatic bone putty, not an algorithm.

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

For the in vivo studies, the "ground truth" would be established through direct observation, physiological measurements, histology, pathology, and possibly imaging (e.g., to assess bone healing), as performed by qualified personnel in the animal studies.

• For the resorption rate studies in rats and rabbits, the ground truth would be the measured presence/absence and degradation of the putty.
• For bone healing studies in rats and sheep, the ground truth would be pathological and histological assessment of bone regeneration and healing.
• For the hemostasis evaluation in sheep, the ground truth would be direct observation and measurement of bleeding control.
• For in vitro studies like cytotoxicity, genotoxicity, and sensitization, the ground truth would be laboratory assays according to ISO standards.

8. The sample size for the training set:

This is not applicable. The device is a physical medical product, not an AI model requiring a training set. The term "training set" is typically used in the context of machine learning.

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

This is not applicable, as there is no training set for a physical medical device.

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