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510(k) Data Aggregation
(145 days)
SKAFFOLD CIS
CAAP (Calcium Apatite) Bone Wax is indicated to control the bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
The single use CAAP (Calcium Apatite) Bone Wax sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula). CAAP Bone Wax is to be mixed immediately prior to use.
The provided text describes a 510(k) summary for the CAAP (Calcium Apatite) Bone Wax, asserting its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study sizes, ground truth establishment, and MRMC studies is not available in the given document.
The document states: "CAAP Bone Wax does not require clinical test."
However, it does mention non-clinical tests. Here's a breakdown of what information can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from non-clinical tests) | Reported Device Performance |
|---|---|
| Biocompatibility (standard set forth in ISO 10993-1) | CAAP Bone Wax is in accordance with ISO 10993-1. |
| Radiation sterilization validation (compliance to ANSI/AAMI/ISO 11137-2:2006) | Radiation sterilization validation is in compliance to ANSI/AAMI/ISO 11137-2:2006. |
| Physiological pH and temperature range (bench testing) | Bench testing demonstrated that CAAP Bone Wax remains within the physiological pH and temperature range and would be expected to show no adverse biological consequence. |
| Adequate hemostasis as a mechanical tamponade compared to predicate devices (animal study) | The animal study provided substantial data that the use of CAAP Bone Wax as a mechanical tamponade to control bleeding in a bony site results in adequate hemostasis as compared with the predicate devices. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not specified. The document mentions an "animal study" but does not detail the number of animals or specific experimental setup.
- Data provenance: Not specified beyond "animal study." No information on country of origin or whether it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document does not describe a human-read test set or expert ground truth establishment for the animal study.
4. Adjudication method for the test set
- Not applicable/Not specified.
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. This is not a study involving AI or human readers. The document states, "CAAP Bone Wax does not require clinical test."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not about an algorithm or AI.
7. The type of ground truth used
- For the animal study: The ground truth was based on the observed "adequate hemostasis" in comparison to predicate devices, implying a functional outcome assessment by the researchers conducting the study. No mention of pathology or other objective measures for this comparison.
- For biocompatibility and sterilization: Ground truth is compliance with specified ISO standards.
- For bench testing: Ground truth is remaining within physiological pH and temperature ranges.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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