(188 days)
The Robinson MedSurg QuickScrew Rack RCK24-143 is intended to organize, hold, and protect the QuickScrew screwdrivers for transport, storage, sterilization, and use during surgery. The subject instrument racks are suitable for use in prevacuum steam. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
Method: Prevacuum Steam Autoclave
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Drying Time: 60 minutes
The Robinson MedSurg QuickScrew Rack RCK24-143 is an instrument rack for organizing, holding, and protecting reusable surgical instruments during transportation, storage, and sterilization. It is designed for adequate exposure of the trays' contents to sterilant during the sterilization process.
The Rack is made of anodized aluminum with polytherimide tube holders for the instruments and to allow for air and sterilant to flow through and around the rack.
The request is about a medical device called the "Robinson MedSurg QuickScrew Rack RCK24-143," a sterilization rack. The provided documentation (K093800) is a 510(k) premarket notification summary and related FDA correspondence. This device is not an AI/ML powered device, therefore the vast majority of the requested information is not available and does not apply to this device.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to AAMI ST77:2006 for Containment Devices for reusable medical device sterilization | "The rack conforms to this standard and performed as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The device is a physical sterilization rack, not a software or AI/ML device that would typically have a "test set" in the context of data. The testing mentioned is performance testing for a medical device's function, not a data-driven model.
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)
Not applicable. No "ground truth" establishment by experts in the context of data analysis is described, as this is a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of adjudication methods for a "test set" as this is not an AI/ML or diagnostic device.
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-assisted diagnostic device, so MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "truth" for this device relates to its ability to perform its function (organizing, holding, protecting instruments, and allowing sterilant flow) as validated by performance testing against established standards (AAMI ST77:2006).
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" or corresponding ground truth.
Summary of Device-Specific Information:
The Robinson MedSurg QuickScrew Rack RCK24-143 is a sterilization rack. Its performance testing was conducted according to AAMI ST77:2006 Containment Devices for reusable medical device sterilization. The reported result is that "The rack conforms to this standard and performed as intended." This implies that the acceptance criteria for the device were defined by the requirements outlined in AAMI ST77:2006, and the device successfully met those requirements through the conducted performance tests. The specific details of these tests (e.g., number of test cycles, specific measurements taken) are not provided in the summary.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).