(170 days)
HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible formulation comprised of water soluble and resorbable materials in a putty-like consistency intended for use in the control of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of alkylene oxide polymer-based materials, vitamin E acetate, granular calcium phosphate, and carboxymethylcellulose sodium salt. The material is virtually odorless, off-white in color and can be spread easily onto bone with minimal adhesion to surgical gloves. The bone putty does not require kneading prior to application.
This document describes a traditional 510(k) submission for a medical device called HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria or a comparative effectiveness study involving AI. Therefore, many of the requested details regarding acceptance criteria for AI-assisted devices or MRMC studies are not applicable.
Here's the breakdown of the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of benchmarks or thresholds that the device needed to meet for its performance. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to predicate devices through various tests. The reported performance is descriptive, indicating that the device "demonstrates" or "was shown" to meet the intended use and characteristics.
| Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Handling properties similar to predicate devices | Bench testing verified handling properties (relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling). |
| Biocompatibility in accordance with ISO 10993 | Biocompatibility testing conducted (irritation, sensitization, acute systemic toxicity, genotoxicity, implantation/subacute toxicity, LAL, and pyrogenicity) on the final, finished, gamma-radiation sterilized device. |
| Intraoperative in vivo hemostasis | Animal studies demonstrated intraoperative in vivo hemostasis. |
| Resistance to irrigation | Animal studies demonstrated resistance to irrigation. |
| Ability to remove the device | Animal studies demonstrated ability to remove the device. |
| Characterize absorption time | Animal studies characterized absorption time. |
| Overall substantial equivalence to predicate devices in intended use, technological characteristics, and performance. | "HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is substantially equivalent to previously cleared and preamendment bone wax devices with respect to intended use, general technological characteristics and performance." |
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 explicitly state specific sample sizes for each bench, biocompatibility, or animal test. It refers to "Bench Testing," "Biocompatibility Testing," and "Animal Testing" as categories. The provenance of the data (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 applicable. The device is a bone putty, and its performance is evaluated through physical, chemical, and biological tests, not by expert interpretation of data like medical imaging. Therefore, "experts" in the context of establishing ground truth for a test set (e.g., radiologists) are not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical trials or studies involving human assessment where disagreements need resolution. The testing described for this bone putty does not involve such a process.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the HEMOSTATIC BONE PUTTY 3 is. The product is a physical bone hemostatic agent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance evaluation was not done. This metric is specific to AI algorithms and is not relevant for a physical medical device like bone putty.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through established scientific and engineering principles measured by:
- Bench Test Results: Physical properties like stiffness, spreadability, stickiness, temperature sensitivity, dissolution, and swelling are measured directly.
- Biocompatibility Test Results: Measured outcomes in laboratory tests (e.g., irritation, sensitization levels).
- Animal Study Observations: Direct observation of hemostasis, irrigation resistance, device removal, and absorption time in an animal model.
These are objective measurements and observations rather than subjective expert consensus or pathology reports in the traditional sense.
8. The sample size for the training set
This information is not applicable. The device is a physical product and does not involve AI algorithms that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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