(66 days)
The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.
The CTS Blower/Mister is comprised of a handpiece and malleable shaft enabling positioning of the device near the targeted site. Connectors on the device allow for hook-up to standard gas and saline sources. The device permits both an adjustable flow of gas and a mist of saline to be deposited at the targeted site.
The provided text describes a 510(k) premarket notification for the CTS Blower/Mister. However, it does not include detailed acceptance criteria or a comprehensive study demonstrating that the device meets those criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, patient population, functionality, and performance, with a brief mention of functional bench testing.
Therefore, for many of the requested points, the information is not available in the provided text.
Here is an analysis based on the given information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria (e.g., quantitative metrics) or
detailed reported device performance against such criteria. It generally states:
| Criteria Category | Stated Performance (or equivalence claim) |
|---|---|
| Intended Use | "The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility." |
| "substantially equivalent to Medtronic's ClearView Blower/Mister and Ethicon's FlexiView CO2 Blower with Mist in regards to intended use..." | |
| Functionality | "performs as designed" |
| "substantially equivalent... in regards to... functionality" | |
| Performance | "suitable for its intended use" |
| "substantially equivalent... in regards to... performance" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Functional bench testing has been conducted," but does not provide details on:
- Sample size (e.g., number of devices tested, number of test cycles).
- Data provenance (e.g., country of origin, retrospective or prospective).
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. The "study" mentioned is "functional bench testing," which typically involves engineering or lab personnel, not medical experts establishing ground truth for clinical outcomes or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is typically relevant for studies involving human interpretation or subjective assessments, which are not described here.
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. An MRMC study is not mentioned. The device is a Blower/Mister for surgical visibility, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical instrument, not an algorithm. The "functional bench testing" can be considered a standalone performance evaluation of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "functional bench testing," the ground truth would likely be engineering specifications, design requirements, or operational parameters (e.g., expected flow rates, mist dispersion patterns). The document does not specify the exact type of ground truth.
8. The sample size for the training set
Not applicable. This device is a physical medical instrument, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.