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HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

HBP7 Settable Hemostatic Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP7 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyetherbased polymers. When mixed together, the components of the HBP7 device form a nonabsorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. HBP7 must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. HBP7 Settable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

This document describes the HBP7 Settable Hemostatic Bone Putty, a medical device indicated for controlling bleeding from cut or damaged bone by acting as a mechanical barrier. The device's substantial equivalence to predicate devices is established through a series of performance tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for HBP7 Settable Hemostatic Bone Putty in the format of a table with specific thresholds. Instead, it describes various performance tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, indicating that the device "demonstrates" or "verifies" certain properties or functions similar to the predicates.

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 does not specify the sample sizes for the "test set" in terms of how many devices, animals, or specimens were used for the bench, biocompatibility, or animal studies. It states that tests were "conducted" and "demonstrate" substantial equivalence.
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

This information is not provided in the document. The studies performed (bench, biocompatibility, animal) do not typically rely on expert consensus for "ground truth" in the way an AI diagnostic device would. Instead, their "ground truth" comes from established scientific methods, laboratory observations, and medical standards.

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

This information is not applicable and is not provided. Adjudication methods like "2+1" are relevant for expert review of images or data, typically in diagnostic AI studies. The tests described here are physical, chemical, and biological evaluations, not requiring such adjudication.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The HBP7 is a physical medical device (bone putty) and not an AI-powered diagnostic tool, so such a study would not be applicable.

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

A standalone performance study of an algorithm was not done. The HBP7 is a physical medical device, not an algorithm, so this concept does not apply.

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

For the bench testing, the "ground truth" would be objective measurements and observations against pre-defined engineering and material science standards (e.g., stiffness measurements, dissolution rates).
For biocompatibility testing, the "ground truth" is derived from established biological assays and observation protocols outlined in ISO 10993, assessed by scientists/toxicologists.
For animal testing, the "ground truth" for hemostasis is direct observation of bleeding control and resistance to irrigation in a live animal model, assessed by veterinary surgical staff and researchers.
There is no "expert consensus" or "pathology" in the typical sense of diagnostic ground truth. Outcomes data for patients is not mentioned, as this is a premarket notification, not a large-scale clinical trial.

8. The sample size for the training set

This information is not applicable and is not provided. The HBP7 is a physical medical device, not an AI model, therefore it does not have a "training set" in the context of machine learning.

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

This information is not applicable as there is no "training set" for this physical device.

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MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-QS device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-QS device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. MONTAGE-QS must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

This document (K191140) is a 510(k) Premarket Notification for a medical device called "MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria via a clinical study with a detailed test set, ground truth, and expert evaluation as would be the case for a diagnostic AI/ML device.

Therefore, the information requested for acceptance criteria and a study proving the device meets those criteria (especially points 1 through 9 pertaining to diagnostic performance, expert review, MRMC studies, etc.) cannot be fully extracted or accurately described from the provided text.

Here's a breakdown of what can be extracted and why other points cannot be addressed:

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

This document does not present acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or statistical thresholds for improved human reader performance with AI. Instead, it focuses on performance testing to demonstrate substantial equivalence to a predicate device in terms of physical properties, biocompatibility, and functionality.

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

• Sample Sizes: Not explicitly stated for specific tests. The document refers to "bench studies," "biocompatibility studies," and "animal studies" without specifying the number of samples or animals used in each.
• Data Provenance: Not specified. These are engineering and preclinical tests, not clinical data from patients.

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. The "ground truth" for this device's evaluation is based on objective physical/chemical measurements (bench testing), biological reactions (biocompatibility), and observed in-vivo effects in animal models, not on human expert radiologist or clinician interpretations.

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

Not applicable, as this testing does not involve human interpretation or adjudication of diagnostic findings.

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. This device is a bone hemostatic putty, not an AI/ML diagnostic tool meant to assist human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device's performance is established through:

• Standardized physical and chemical property measurements (e.g., stiffness, dissolution rates).
• Validated biocompatibility assays (ISO 10993 series).
• Direct observation of hemostatic efficacy and resorption in animal models.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. This device does not involve machine learning or a "training set."

Summary of Device and Evidence Presented:

The MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material intended to control bleeding from cut or damaged bone by acting as a mechanical barrier. The 510(k) submission successfully demonstrated substantial equivalence to a predicate device (MONTAGE Settable, Resorbable Hemostatic Bone Putty K152005) through:

• Bench Testing: Verifying handling properties (stiffness, spreadability, stickiness), temperature sensitivity, electrocautery compatibility, dissolution, and swelling.
• Biocompatibility Testing: According to ISO 10993 recommendations (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity).
• Animal Testing: Demonstrating intraoperative in vivo hemostasis, resistance to irrigation, local tissue response, and characterizing resorption time.
• Technological Characteristics Comparison: Showing the device is "nearly identical" in configuration, formulation (with one exception for faster setting time), materials (primarily calcium phosphate), and principle of action (mechanical tamponade) to the predicate.

The FDA clearance (K191140) implies that based on these non-clinical tests, the device is considered as safe and effective as the legally marketed predicate device for its stated Indications for Use.

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