(206 days)
The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .
The Oscera7™ Synthetic Absorbable Bone Wax is a kneadable, biocompatible, synthetic absorbable material indicated for control of bleeding from bone surfaces. Hemostasis is accomplished by the physical mechanism of tamponade as it is pressed into the pores of the cut or damaged bone surface.
Post-application, the component materials, which include a fatty acid salt, isopropyl hexadecanoate, an alkylene oxide copolymer and ß-tricalcium phosphate, are dispersed and absorbed within the body.
The provided text describes a 510(k) submission for the Oscera7TM Synthetic Absorbable Bone Wax. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies in the format requested for AI/software devices.
Therefore, many of the requested fields cannot be directly extracted or are not applicable to this type of medical device submission. However, I can infer some information based on the context of a 510(k) and the provided text.
Here's a breakdown of the available and inferred information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Hemostatic Capability | Effective control of bleeding from cut or damaged bones by acting as a pressure tamponade/mechanical barrier. | Demonstrated in bench and animal testing. |
| Bioresorbability | Component materials (fatty acid salt, isopropyl hexadecanoate, alkylene oxide copolymer, ß-tricalcium phosphate) are dispersed and absorbed within the body post-application. | Demonstrated in bench and animal testing. |
| Biocompatibility | No adverse biological reactions. | Demonstrated in bench and animal testing. |
| Functionality | Device performs its intended purpose. | Demonstrated in verification testing. |
| Safety | No unacceptable risks to the patient. | Demonstrated in verification testing. |
| Effectiveness | Achieves the desired clinical outcome (hemostasis). | Demonstrated in verification testing. |
| Substantial Equivalence | Same intended use as predicate devices, absorbable, and uses materials found individually in predicate products. | Confirmed by FDA based on the submission. |
Explanation of Inference:
- Acceptance Criteria: These are inferred from the "Intended Use," "Device Description," and "Design Verification" sections. For a 510(k), compliance with these functional requirements and demonstrating substantial equivalence to legally marketed predicate devices are the primary "acceptance criteria."
- Reported Device Performance: The document states that "Verification testing of Oscera7™ included both bench and animal testing. The testing demonstrated the hemostatic capability, bioresorbability, and biocompatibility, thereby establishing compliance to the functional requirements of the device." It also concludes that "the cumulative test results demonstrated the functionality, safety and effectiveness of Oscera7™, as well as its substantial equivalence to the predicate devices."
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The text only mentions "bench and animal testing" but does not specify sample sizes or data provenance (e.g., country, retrospective/prospective). This level of detail is typically not included in a 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided and is not applicable to a non-AI/software medical device like bone wax. "Ground truth" in this context would likely refer to direct measurements or observations from animal models or bench tests, not expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation, especially for diagnostic or screening devices.
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 as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Based on the type of device and testing mentioned ("bench and animal testing"), the "ground truth" would likely be established through:
- Direct measurement/observation in bench tests: For properties like mechanical integrity, absorption rates, or material composition.
- Histopathology or physiological measurements in animal models: To assess hemostasis, bioresorption, and biocompatibility (e.g., inflammation, tissue integration, presence/absence of material).
- Clinical observation in animal models: For immediate hemostatic effect.
The document does not explicitly state the specific ground truth methods but implies these through the types of tests mentioned.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to this type of device. "Training set" is a term used in machine learning; this device undergoes traditional design verification and validation testing.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable to this type of device for the same reasons as #8.
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