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The PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.

The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

This submission (K040149) is a 510(k) premarket notification for a medical device called "The PSI TEC III Peristaltic Infiltration Pump." A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for the new device as would be seen for novel technologies or higher-risk devices.

Based on the provided document, there is no information available about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested details about such a study.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This confirms that the approval was based on substantial equivalence, not on a standalone performance study with defined acceptance criteria for the new device K040149 itself.

Here's an attempt to answer the questions based on the available text, highlighting what is not present:

1. Table of acceptance criteria and the reported device performance

   • Not provided. The document does not specify performance acceptance criteria for the new device (PSI TEC III Peristaltic Infiltration Pump) or report specific performance metrics against such criteria. The submission is framed around substantial equivalence to existing devices.

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/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary. The approval is based on substantial equivalence to predicate devices, not on a performance study of the PSI TEC III itself.

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/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

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 device is an irrigation/infusion pump, not an AI-assisted diagnostic tool. No MRMC study would be relevant here.

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

   • Not applicable. This device is a pump, not an algorithm. Standalone performance for a physical device would refer to its functional specifications (e.g., flow rate accuracy, pressure), but these are not detailed as specific performance study results in this summary. The substantial equivalence argument implicitly assumes its performance is comparable to predicates.

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

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

8. The sample size for the training set

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

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

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

Summary of available information related to equivalence:

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Predicate Devices for Substantial Equivalence Claim:

• Product: Bi-Phasic Infiltrator
  • Manufacturer: Reliance Medical
  • 510(k) Number: K012044
  • Substantial Equivalence Date: August 28th, 2001
• Product: Autofuse V Infiltration Pump
  • Manufacturer: Randolph-Austin
  • 510(k) Number: K980394
  • Substantial Equivalence Date: March 25th, 1998
• Product: Wells-Johnson Infusion System
  • Manufacturer: Wells-Johnson
  • 510(k) Number: K991437
  • Substantial Equivalence Date: August 30th, 1999

The substantial equivalence claim is based on the "principles of operation and technology incorporated" being similar to these predicates, specifically mentioning that the PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing, similar to other peristaltic irrigation systems. It also mentions that, like all peristaltic pumps, it contacts only the tubing and not the fluid, thus maintaining sterility.

In conclusion, for this specific 510(k) submission, the device did not undergo a study to meet defined acceptance criteria in the way a novel diagnostic or therapeutic device might. Its approval was based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

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