(170 days)
Auto Suture* Bone Wax** is indicated for use in the control of bleeding from bone surfaces.
Auto Suture* Bone Wax** is designed to control bleeding from bone surfaces by the creation of a mechanical barrier.
This 510(k) submission for "Auto Suture* Bone Wax**" (K971680) falls under the category of a traditional 510(k) where substantial equivalence is primarily established through comparison to predicate devices, rather than through extensive clinical trials or performance studies with specific acceptance criteria that would typically be described for a new diagnostic or prognostic algorithm.
Therefore, the provided text does not contain the detailed information requested regarding acceptance criteria and a study proving a device meets them in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). This type of submission relies on the established safety and efficacy of previously marketed, substantially equivalent devices.
Specifically, the document states:
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the FDA's clearance is based on the device being similar enough to predicate devices (Ethicon™ Bone Wax and Lukens™ Bone Wax) whose safety and effectiveness are already understood.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone performance is not present in this document.
However, I can extract the relevant information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria for device performance or provide a table of reported performance metrics in the way one would for a diagnostic device. The "performance" described focuses on the device's mechanism of action and material biocompatibility.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Material Biocompatibility | "All material components of Auto Suture* Bone Wax** have been evaluated for biocompatibility in accordance with ISO Standard #10993-1. The materials have been found to be safe for their intended use." |
| Intended Use | "Auto Suture* Bone Wax** is designed to control bleeding from bone surfaces by the creation of a mechanical barrier." (Similar to predicate devices) |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission does not describe a "test set" in the context of evaluating a diagnostic algorithm's performance. The substantial equivalence is based on device characteristics and intended use in comparison to predicate devices.
- The material biocompatibility evaluation would have involved in vitro or in vivo tests, but specific sample sizes or data provenance for those tests are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No test set for ground truth establishment is described or implied in this 510(k) summary.
4. Adjudication method for the test set:
- Not Applicable. No test set requiring adjudication is described.
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 is not an AI/software device, and no MRMC comparative effectiveness study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used:
- Not Applicable for algorithm performance. The "ground truth" for this device's acceptance is its similarity to predicate devices in terms of materials, mechanism of action, and intended use, along with demonstrated biocompatibility of its components.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning device and therefore does not have a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth for it.
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