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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).

AI/ML Overview

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.

Acceptance Criteria Category	Description of Performance/Test Conducted	Reported Device Performance
Bench Testing	Handlings properties, performance over a range of temperatures, dissolution properties. Includes: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling.	"Bench testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution properties." The specific results meeting acceptance for each sub-test are implied by the statement: "demonstrate that the device is substantially equivalent to the predicate devices in intended use, technological characteristics, and performance."
Biocompatibility	Evaluated in accordance with ISO 10993 recommendations. Includes: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, local tissue toxicity, hemolysis, endotoxicity, and pyrogenicity.	"Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993." The tests were conducted on the "final, finished, gamma-irradiated sterile device in accordance with the GLP requirements." Implied successful outcome as part of demonstrating substantial equivalence.
Animal Functionality	In vivo hemostasis and resistance to irrigation.	"Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation." Implied successful outcome in demonstrating substantial equivalence.
Intended Use	Control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.	"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." This aligns with the predicate devices' intended use for bone hemostasis through mechanical tamponade. Its mechanism of action is identical to the predicates (mechanical tamponade occluding vascular openings).
Sterility	Provided sterile.	"Provided sterile for single use by gamma irradiation." This is consistent with the predicate devices.
Set Time	Ability to set (harden) within minutes of application.	"Sets (hardens) within minutes of application." This is a characteristic shared with the MONTAGE predicate device (K141502 and K152005), which also "Sets (hardens) within minutes of application." CP Medical Bone Wax (K024372) is "N/A" for set time because it hardens after application through kneading, not a chemical set.
Form of Device	Two-part putty/putty device that forms a settable (hardening) putty when manually mixed.	HBP7 "is formulated as a two-part putty/putty device that forms a 'settable' (hardening) putty when manually mixed at the time of surgery." This is analogous to MONTAGE, which is also a "two-part putty/putty device that forms a 'settable' (hardening) putty when manually mixed." CP Medical Bone Wax is a single component to be kneaded.
Materials	Sterile mixture of two components of putty-like consistency: granular calcium phosphate (hydroxyapatite and β-tricalcium phosphate), paraffin, vitamin E acetate, triacetin, and a mixture of nonabsorbable polymers. Primarily comprised of calcium phosphate.	The materials described are consistent with the device description and the comparison to predicates, particularly MONTAGE, which also contains granular calcium phosphate, vitamin E acetate, and polymers, differing primarily in the absorbability of its polymers. The HBP7 device's composition is stated to be primarily comprised (>60% by weight) of calcium phosphate.
Absorbability	Nonabsorbable.	"No" (nonabsorbable). In vivo residence time is a "Permanent Implant." This differs from MONTAGE (absorbable) but is consistent with CP Medical Bone Wax (nonabsorbable).
Degradation Process	Nonabsorbable in the body; permanent implant.	"Nonabsorbable in the body - permanent implant." This is identical to CP Medical Bone Wax. MONTAGE has a degradation process involving dissolution and hydrolysis.
Radiopacity	Contains hydroxyapatite and β-tricalcium phosphate resulting in radiopacity.	"Radiopaque - Contains hydroxyapatite and β-tricalcium phosphate." This is similar to MONTAGE (also radiopaque due to these components) but differs from CP Medical Bone Wax (not radiopaque).

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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