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510(k) Data Aggregation
(103 days)
The Convertors® SMS Drapes and Accessories are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
These drapes will be composed of a trilaminate Spunbond/Meltblown/Spunbond Polyolefin nonwoven fabric with an adhesively laminated reinforcement fabric around the fenestration.
The provided text describes the 510(k) summary for the Allegiance Convertors® SMS Drapes and Accessories. It outlines the device's intended use and claims of substantial equivalence to a predicate device, the Kimberly-Clark Evolution III Drapes. The testing described focuses on material properties and biocompatibility rather than a clinical performance study with human subjects or AI-assisted diagnostic tasks.
Therefore, many of the requested categories (such as MRMC study, effect size, human readers, training set details, and specific expert qualifications for ground truth in a clinical context) are not applicable to this submission.
Here is the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Met the requirements of the identified tests and found acceptable. |
| Sensitization | Met the requirements of the identified tests and found acceptable. |
| Irritation/Intracutaneous Reactivity | Met the requirements of the identified tests and found acceptable. |
| Physical Properties: | |
| Flammability | Performed; met the requirements of the identified tests and found acceptable. |
| Hydrostatic Head | Performed; met the requirements of the identified tests and found acceptable. |
| Impact Penetration | Performed; met the requirements of the identified tests and found acceptable. |
| Alcohol Repellency | Performed; met the requirements of the identified tests and found acceptable. |
| Elmendorf Tear | Performed; met the requirements of the identified tests and found acceptable. |
| Tensile Strength | Performed; met the requirements of the identified tests and found acceptable. |
| Overall Equivalence: | |
| Intended Use | Same as predicate device (Kimberly-Clark SMS (Evolution III) drapes). |
| Performance attributes | Similar to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The testing was conducted on material samples, not on a human patient population.
- Data provenance: Not specified. This was material testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device involved laboratory testing against material standards, not expert medical opinion on clinical cases. The tests were likely conducted by qualified laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical diagnostic studies involving human readers and interpretation. This submission describes physical and biological material testing.
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 MRMC comparative effectiveness study was done. This device is a surgical drape, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (surgical drape), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by recognized industry standards and test methodologies for biocompatibility and physical material properties, as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices" and other unspecified physical test standards.
8. The sample size for the training set:
- Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
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