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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:

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.

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This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.

The ClearView Blower/Mister includes a hand grip with a 3 1/4" or 6 1/2" malleable stainless steel shaft for ease of positioning the device near the surgical site. The soft, silicone tip contains a plastic tube which carries saline to the tip. The proximal end includes a fluid inlet line which terminates in a locking female luer for connection to the fluid administration set. The gas line, located on the proximal end, has an in-line 0.2 micron filter and terminates in a slip connector for connection to the gas source tubing.

Here's an analysis of the provided text, focusing on acceptance criteria and the study demonstrating that the ClearView Blower/Mister meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes (e.g., number of devices tested, number of repetitions for each test) for the non-clinical performance data. It describes the tests conducted on "this device" (ClearView Blower/Mister) and "the predicate device."

The data provenance is not explicitly stated. Given it's a 510(k) submission, it's highly likely to be internal company testing (Medtronic/DLP) conducted in a controlled laboratory environment. The testing is prospective in the sense that the experiments were designed and executed to evaluate the new device against its predicate and established criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this submission. The tests performed are non-clinical, measuring physical characteristics and performance of the device (force, mist pattern, flow rates). Ground truth was established through direct physical measurement using scientific instrumentation, not through expert consensus or clinical evaluation.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective physical measurements, there's no need for an adjudication method as would be used for subjective assessments or image interpretation.

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

There was no MRMC comparative effectiveness study conducted. This is a non-clinical evaluation of a surgical device, not an AI or imaging diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical performance tests was based on objective physical measurements using instruments and controlled experimental setups. This includes:

• Measurement of force exerted by the gas/saline stream.
• Visual/instrumental assessment of mist pattern shape and centering.
• Measurement of air and saline flow rates.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

This information is not applicable. As stated above, there is no training set. The "ground truth" for the performance evaluation was established through direct physical measurements of the device's characteristics.

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