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The Cowboy XV is designed to enhance blood circulation in the venules and arterioles in the lower extremities. The Cowboy XV Is designed to only patients with diabetic ulcers of the lower extremities.

Cowboy XV is intended for patient's in the home who would benefit from increased blood flow to:

• treat and assist healing of cutaneous ulceration (wounds).
• reduce wound healing time.
• enhance arterial circulation (blood flow).
• prevent venous stasis (slowing of blood flow).
• reduce compartmental pressures.
• reduce edema (swelling).
• reduce post-operative pain and swelling.
• reduce the need for anticoagulant medications (medications that thin the blood).
• prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins).

The Cowboy XV pump is connected through tubing to a foot wrap(s). When inflated, these wraps mimic the normal physiological actions of walking, thus helping to open up and improve blood flow and circulation in the venules and arterioles in the lower extremities. This improved blood flow means a greater chance of prolonging the time before or preventing amputation as their wounds heal.

Cowboy XV functions as an intermittent pneumatic compression device that enhances lower extremity blood circulation. Cowboy XV is not a life-supporting or life-sustaining device. Cowboy XV is not an implant (short-term or long-term), nor is it a sterile device. Cowboy XV is an electrically-operated (designed to meet UL 1431), software-driven, prescription device, which is used in the home environment. Cowboy XV is comprised of two major components – the reusable pump unit and a single-patient use inflatable foot wrap. Neither component contains a drug nor biological product as a subcomponent.

Cowboy XV uses a 16 foot hospital grade power cord to supply a voltage of 115 volts AC at a frequency of 60 Hz with a maximum current consumption of 0.33 amperes and a maximum electrical leakage of less than 100 microamperes from its power source. An exterior shell made of Prism CM-200 material, measuring 12" long by 10 % " wide by 7" high, houses the 11 pound unit.

The compressor inflates one or more of the wraps in minimum intervals of 20 seconds at a pressure of not less than 15 mmHg and not more than 180 mmHg (± 15 mmHg).

The unit features a microprocessor that controls the unit's operation. The frequency and intensity of the compressions, as well as the duration of the compressions, are all preset values which are monitored and controlled by the microprocessor. The microprocessor also has detection capabilities to monitor the pressure in the wrap(s), adjusting the in and out flow of air as needed. If for any reason the target pressure cannot be maintained, the microprocessor alarm capabilities will activate both visual and audio alarms. These alarm capabilities are built into the unit to alert the user of any unit malfunction situations, should they ever occur.

The non-sterile inflatable foot wraps are for single-patient use only. Each wrap is designed to fit around and compress the veins of the foot. The foot wrap is wrapped around the foot. Hook and loop fasteners are used to hold the foot wrap comfortably around the foot. This air bladder is RF-welded to create an air-tight seal, which can then be inflated by Cowboy XV. This air bladder is designed to create a pressure against the body.

The provided text is a 510(k) Summary for a medical device called "Cowboy XV," an intermittent, external pneumatic compression device. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the "Cowboy X" (PlexiPulse® Acute Care Unit).

Based on the nature of this document (a 510(k) summary for a pneumatic compression device), it is highly unlikely to contain information about acceptance criteria and a study proving device performance in the context of advanced AI/ML algorithms, multi-reader multi-case studies, or the methodologies typically associated with assessing the performance of such algorithms (e.g., sample sizes of test/training sets, expert ground truth, adjudication methods).

The "performance" described in this document relates to the mechanical function of the device (inflation pressure, intervals, alarm capabilities) and its clinical intended use (enhancing blood circulation, treating and healing ulcers, etc.), which would have been assessed through different types of studies (e.g., clinical trials for efficacy, engineering tests for safety and functionality) as part of the 510(k) clearance process. However, the provided summary does not include details about these studies or specific acceptance criteria with reported device performance data in a quantitative manner as you've requested for AI/ML devices.

Therefore, I cannot populate the table or answer the specific questions about AI/ML study design, sample sizes, expert qualifications, or adjudication methods, as this type of information is not present in this 510(k) summary.

Here's what I can extract from the provided text about the device and its intended function, acknowledging that it doesn't fit the AI/ML framework of your request:

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

(Note: These are functional descriptions, not formal acceptance criteria with specific thresholds and associated study results for AI/ML performance metrics like sensitivity/specificity.)

Study that proves the device meets the acceptance criteria:

The document does not explicitly describe a specific study with detailed methodology, sample sizes, and results to prove the device meets these functional criteria. The 510(k) process typically relies on demonstrating substantial equivalence to a predicate device, supported by various tests and documentation proving safety and effectiveness. The text states:

• "The predicate device to which substantial equivalence is being claimed is Cowboy X (a.k.a. PlexiPulse® Acute Care Unit), also manufactured for NuTech by KCI. The PlexiPulse® Acute Care Unit is the hospital version of Cowboy XV and has been in hospitals for approximately 6 years." This implies that the predicate's established performance and safety are leveraged for the new device.
• The description of the device's operational parameters (inflation pressure, intervals, alarm systems) serves as a statement of its design and expected performance, which would have been validated through engineering testing, but details of such studies are not provided.

Regarding the AI/ML specific questions (2-9):

2. Sample sizes used for the test set and the data provenance: Not applicable. This device is a mechanical pneumatic compression pump, not an AI/ML algorithm that processes data like images or patient records.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to labels for data. This device does not use labeled data in this manner.
4. Adjudication method: Not applicable.
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 does not involve human readers interpreting data with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. The device doesn't "learn" from a training set in the AI/ML sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document is for a traditional medical device, not an AI/ML powered one. Therefore, the specific questions related to AI/ML study methodologies cannot be answered from this text.

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The Inflatable Positioning Cushion with Remote Hand Control is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion (a.k.a. ImageAir) allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

The ImageAir Remote Hand Control is a remote control transmitter, utilizing 4 AA batteries. It is utilized in conjunction with an integrated Infrared receiver, located in the Main Control Panel of the Blower Assembly, to inflate and deflate the air cushions. The Remote Control transmitter incorporates a membrane keypad which provides control over the following functions:

• Torso Strap On/Off .
• Head Strap On/Off .
• Height Adjust Up/Down .
• Roll Adjust Left/Right .
• Roll Adjust Level .
• Lower All (Patient Exit) .
  The Blower Assembly incorporates a microprocessor control as an additional safety feature to ensure the valves which regulate air pressure to the various inflatable cushions are operated in the proper sequence. For example, it would be inadvisable to raise or lower the patient when the table locking straps are disengaged. The microprocessor inside the blower box monitors strap status and will not allow the valves which direct air into the height adjustment cushions to be operated until the straps are verified as being locked.

The provided document is a 510(k) Pre-Market Notification for a medical device: "Inflatable Positioning Cushions with Remote Hand Control" (also known as ImageAir). This document outlines the device's description, indications for use, and a statement of substantial equivalence to predicate devices. It does not contain any information regarding clinical studies, acceptance criteria, or performance data comparing the device to a ground truth.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because the document does not contain this type of data.

To clarify, the 510(k) process is primarily a pre-market notification to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. It does not typically require the submission of clinical trial data or performance studies in the same way a Premarket Approval (PMA) would. The provided document focuses on descriptions, intended use, and a comparison to existing, similar devices to establish this substantial equivalence.

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The Inflatable Positioning Cushion device is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion device allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

The Inflatable Positioning Cushion is designed to be used on a standard nuclear imaging table with cradle dimensions of 80" long by 14" wide, such as the SPECT Table manufactured by Medical Imaging Electronics. The Inflatable Positioning Cushion is comprised of a Head Section and Abdominal Section, containing foam cushions and inflatable cushions, and a Lower Body Section of foam cushions. The cushions are secured to the nuclear imaging table with Velcro straps and inflatable straps that wrap underneath the table. The blower for the inflatable cushions is in a separate enclosure that can hang at the end of the nuclear imaging table or sit on the floor.

This is a 510(k) summary for a medical device and therefore does not contain the detailed study information typically found in a standalone clinical study report. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than proving performance against specific acceptance criteria through a dedicated study.

However, based on the provided text, we can infer some information and identify what is missing.

Inferred Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices. The device's performance is described in terms of its intended use and features, positioning it as functionally equivalent to the predicates.

Missing Information (Commonly found in detailed study reports):

The provided text does not contain the following detailed study information typically associated with a robust performance evaluation against specific acceptance criteria for AI/diagnostic devices:

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

   • Missing. There is no specific test set or data mentioned for the subject device. The clearance is based on substantial equivalence to existing devices.

2. 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):

   • Missing. This type of evaluation is not relevant for a physical positioning device.

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

   • Missing. Not relevant for this type of device.

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:

   • Missing. This is a physical support device, not an AI or diagnostic imaging device that involves human readers interpreting results.

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

   • Missing. Not applicable; this is not an algorithm.

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

   • Missing. The "ground truth" for this device would be its ability to physically position a patient comfortably and correctly for scintimammography, and to do so without interfering with image acquisition (e.g., radiolucency). This is evaluated through engineering specifications, material properties, and comparison to predicates, rather than clinical ground truth for a diagnostic outcome.

7. The sample size for the training set:

   • Missing. This is not an AI/machine learning device that requires a training set.

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

   • Missing. Not applicable.

Crucial Point: This 510(k) submission is for an "Inflatable Positioning Cushion," a relatively low-risk physical accessory. The FDA's 510(k) process for such devices relies heavily on demonstrating substantial equivalence to predicate devices already on the market, rather than requiring extensive clinical trials with specific performance endpoints like those for new diagnostic or therapeutic technologies. The "study" mentioned for the predicate device (Scintimammography Prone Breast Cushion) was a clinical study on the technique of scintimammography itself and the efficacy of that predicate cushion in the detection of breast cancer, not a study specifically on the acceptance criteria of the new inflatable cushion alone. Therefore, the information you're looking for regarding concrete performance metrics and detailed study designs is not typically part of such a 510(k) substantial equivalence submission for this type of device.

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