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Use of the Venturi™ NPWT v.II Advanced Vacuum System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patient's bedside.

The Talley Venturi™ system consists of a powered suction pump for the application of vacuum for fluid removal. Consumables for use with the pump include collection canister and connection tubing.

The provided document is a 510(k) summary for the Talley Venturi™ NPWT v.II Advanced Vacuum System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical effectiveness or meeting specific performance criteria through a detailed study on human patients. Therefore, information typically found in clinical studies (like sample sizes for test sets, expert qualifications, MRMC studies, training set details, or ground truth establishment for clinical outcomes) is not present in this document because it is not required for a 510(k) summary of a powered suction pump.

The document primarily focuses on bench testing to ensure the device functions correctly and is safe, aligning with its substantial equivalence claim to predicate devices.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample size for test set: The "Specific Performance Testing" section states that tests are performed on 100% of production units or 100% of production sub-assemblies. This implies a continuous quality control process rather than a one-time test set. For the purpose of regulatory submission, it refers to the units tested to demonstrate the device meets its own specifications.
• Data provenance: Not explicitly stated, but these are internal manufacturing and testing data from Talley Medical. There is no indication of country of origin for clinical data as no clinical data is presented. It's prospective testing in the sense that units are tested as they are produced.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for these tests are objective, measurable physical parameters (e.g., pressure, flow, air-tightness) specified by engineering and design requirements, not subjective expert assessment.

4. Adjudication method for the test set:

• Not applicable. The tests are pass/fail based on objective measurements against defined minimum values or specified functionalities. There is no human adjudication process described for these engineering tests.

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. This is a mechanical device (powered suction pump), not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study is not relevant or included.

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

• Not applicable. This is a powered suction pump, not an algorithm or AI system.

7. The type of ground truth used:

• For the described tests, the "ground truth" is defined by engineering specifications and functional requirements (e.g., specific pressure ranges, flow rates, air-tightness, correct operation of buttons, alarms, charging system).

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The development of the device would involve engineering design and iterative prototyping and testing, but not a dataset for algorithm training.

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

• Not applicable. As above, no training set in the context of AI/ML.

In summary: The document describes standard engineering and manufacturing quality control tests to ensure the device performs according to its design specifications and is substantially equivalent to existing predicate devices. It does not involve complex clinical studies or AI/ML evaluations.

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Use of the Venturi™ Negative Pressure Wound Therapy system is indicated for use for patients with acute or chronic wounds that may be benefited by the application of neqative pressure therapy and the potential wound healing effects of removal of fluids including wound exudates, irrigation fluids, and infectious materials. Venturi is intended for use in acute care settings only.

The Talley Venturi™ system consists of a powered suction pump for the application of vacuum to wounds for fluid removal. Consumables for use with the pump include collection canister, connection tubing, drain, and wound dressing products.

The provided document, K080897, is a 510(k) summary for the Talley Venturi™ Negative Pressure Wound Therapy system. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through technological characteristics and basic performance testing, rather than an elaborate clinical study with detailed acceptance criteria and performance metrics in the way a new, high-risk device might be evaluated.

Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present or are not applicable in this 510(k) submission. I will extract the information that is available and explain where the requested information is not provided by the document.

Acceptance Criteria and Reported Device Performance

Study Details and Missing Information:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document indicates that all performance tests (Canister Vacuum, Vacuum Pump, Soak, and Final System Tests) were performed on 100% of production units or sub-assemblies. This implies a continuous quality control process for manufacturing rather than a discrete "test set" in the context of a clinical study or performance verification using a limited sample.
   • Data Provenance: Not explicitly stated. The tests described are manufacturing quality control checks, so the data would originate from the manufacturing facility. There is no mention of country of origin for clinical data, as this is not a clinical study. The testing described is prospective as it's part of the manufacturing process for each unit.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not provided. The "ground truth" for the engineering performance tests (e.g., proper pressure, air-tightness) is established by predefined engineering specifications and calibration standards for the device components and system, not by clinical experts.

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

   • Not applicable / None specified. The tests described are pass/fail engineering tests based on objective measurements against internal specifications. There is no expert adjudication process mentioned.

4. 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. This document is for a Negative Pressure Wound Therapy system (a physical medical device, essentially a pump), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI effectiveness are not applicable.

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

   • Not applicable. As above, this is a physical medical device, not an algorithm. Performance is assessed based on the device's physical functions.

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

   • The "ground truth" for the engineering performance tests mentioned is based on predefined engineering specifications and calibration standards for vacuum, pressure, and operational functions.
   • For the overall substantial equivalence claim, the "ground truth" is the performance and established safety of the predicate devices (Blue Sky Versatile 1 System K042134, K052456 and Boehringer Labs Suction Pump system K061788). The new device is deemed acceptable if its technological characteristics and performance are comparable.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an engineering performance study for a physical device like this. This would typically apply to machine learning algorithms.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, this question is not relevant to the information provided.

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Use of the Talley TableGard Pressure Relieving Patient Warming Mattress is indicated for use for patients that may be benefited by the application of heat during surgical procedures to help maintain normothermia. It is intended for use in the operating rooms, recovery rooms, intensive care departments, emergency rooms in hospitals and outpatient clinics to assist patients to maintain normal body temperature. The TableGard mattress also includes alternating air support to relieve pressure against soft tissues during prolonged periods of immobilization.

The TableGard Pressure Relieving Patient Warming Mattress system consists of an alternating air mattress (patient support surface) with air pump, and a connectable and thermally regulated warm air blower unit. The air mattress is enclosed in a vinyl and polyurethane cover, which is in turn fitted with air inlet and outlet ports to receive and recirculate warmed air within the air mattress cover under the patient. The patient is warmed by conduction of heat (regulated between 34° and 40° C) thru the polyurethane cover. The air pump and air blower unit operate on 110V, but there is no electrical contact between the control devices and the patient support mattress. The air pump alternately cycles pressures between sections of the mattress to relieve interface pressure against the patient's soft tissues.

The provided text describes the TableGard Pressure Relieving Patient Warming Mattress (K080763). It focuses on the device's functional and safety testing to support its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria in a human population.

Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, training set information, and specific effect sizes) is not applicable or not available in the provided 510(k) summary.

However, I can extract the acceptance criteria related to the device's functional performance and how it was tested.

Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on functional and safety testing, establishing that the device's performance is acceptable and does not introduce new safety or effectiveness concerns compared to predicate devices. The "acceptance criteria" here are implicitly related to the prevention of thermal injury and effective pressure relief, ensuring the device operates within safe and intended parameters.

Study Details (Based on available information):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The testing described is "functional and safety testing" and "simulated skin temperatures," implying laboratory or engineering tests, not a clinical study with a patient cohort.
   • Data Provenance: Not explicitly stated, but the nature of the tests suggests they were internal laboratory tests conducted by the manufacturer, Talley Medical/Jaxports. These are not human subject data (retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the functional tests would be the physical measurements taken by instruments according to engineering specifications and safety standards, not expert consensus on clinical outcomes.

3. Adjudication method for the test set: Not applicable. This concept is for clinical studies involving human interpretation or outcomes, not functional device testing.

4. 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 a patient warming mattress, not an imaging or diagnostic AI device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm. The device's performance (temperature regulation, pressure relief) is "standalone" in the sense that it operates according to its design parameters.

6. The type of ground truth used: For temperature testing, the "ground truth" was established by measurements of "simulated skin temperatures" against predetermined safety limits (likely based on established thresholds for thermal injury). For pressure relief, the "ground truth" was the physical measurement of "interface pressure" by instruments, demonstrating cyclical and consistent relief according to the device's design.

7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of the study:

The study described is a series of functional and safety tests performed on the TableGard Pressure Relieving Patient Warming Mattress system. These were engineering/laboratory tests, not clinical studies involving human subjects.

• The tests evaluated:
  • Thermal Regulation: Achieved surface temperatures were measured under normal operating conditions and in conditions of possible single-fault failures. The goal was to confirm that the warming system would not cause thermal injury.
  • Pressure Relief: Interface pressure between the patient support surface and the patient was measured to confirm that it was fully relieved on a cyclical and consistent basis.

The conclusion drawn from these tests was that the device met its functional and safety requirements, demonstrating substantial equivalence to predicate devices and not introducing new safety or effectiveness issues.

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