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The Pull Tab Squeeze Flush (PTFS) an attachment to a catheter – transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of el vinning backleakage and waveform damping.

The PTSF is currently made in four models - 3 ml and 30 ml each with or without tee connector.

The Pull Tab Squeeze Flush (PTSF) is a continuous flush device that contains an orifice used to provide a continuous fixed flow rate of IV solution to facilitate arterial pressure monitoring and to maintain patency.

The device also includes a mechanism which, when activated, provides a fast flush flow rate used to prime the device and monitoring kit. The fast flush rate continues to flow as long as the fast flush mechanism is mechanically activated. The fast flush also provides a means to flush the monitoring kit following blood sampling and to allow measurement of the system's dynamic response. The PTSF device is capable of creating a square wave signal in the pressure line to the transducer whenever the fast flush mechanism is activated and quickly released or the tab is squaezed or and released quickly.

The device consists of rigid transparent lure connections for adapting to standard male and/or female lures, a flow restrictor, and a fast flush mechanism. It is available in two nominal flow rates, 3ml/hr and 30 ml/hr. The fast flush mechanism clip may be removed to enable patient mounting of the device.

The provided document is a 510(k) summary for the Pull Tab Squeeze Flush (PTSF) device. It asserts substantial equivalence to a pre-amendment predicate device (Intraflo®). However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. Instead, it relies on the predicate device's established history and general statements about material similarity, intended use, and indications for use.

Therefore, most of the requested information cannot be extracted from this document, as a formal study with acceptance criteria, sample sizes, and ground truth establishment is not described.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states: "No additional safety and performance testing is necessary." and "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Continuous flush catheters." It relies on the predicate's long history of use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No specific test set or study data is mentioned.

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)

• Cannot be provided. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No test set or adjudication process is mentioned.

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

• Cannot be provided. This device is a mechanical medical device, not an AI-assisted diagnostic tool.

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

• Cannot be provided. This request is irrelevant as the device is not an algorithm or AI system.

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

• Cannot be provided. No ground truth is discussed as no new performance study was deemed necessary. The argument for safety and effectiveness is based on the predicate device's market history.

8. The sample size for the training set

• Cannot be provided. There is no mention of a training set as this is not an AI/ML device.

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

• Cannot be provided. There is no mention of a training set or ground truth establishment.

Summary of Device Information from the Document:

While the specific information requested about acceptance criteria and studies is not present, here's what is stated in the document regarding the device's basis for clearance:

Device Acceptance Criteria and Performance (Based on Predicate Equivalence, Not New Study):

Rationale for Substantial Equivalence (instead of new study):

The document argues that the Pull Tab Squeeze Flush (PTSF) is substantially equivalent to the predicate Intraflo® device due to:

• Same intended use.
• Same indications for use.
• Same functions as the predicate device.
• Similar technological characteristics: Both are continuous flush devices that incorporate a fast flush mechanism (pull tab).
• Material similarity: Components made from the same materials with one exception (different vendor for silastic sleeve, which ICU Medical uses on other disposable devices).
• Predicate's long history: "ICU Medical Intraflo has been sold for more than three decades and is proven technology. No additional safety and performance testing is necessary."

This type of 510(k) submission relies heavily on the established safety and effectiveness of a predicate device, and thus often does not include new, comprehensive performance studies with defined acceptance criteria for the new device if the changes are deemed minor and do not raise new questions of safety or effectiveness.

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