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The Ambulatory V.A.C. device is indicated for patients who whould benefit from a suction device, particularly as the device use may promote wound healing, including for patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

The Ambulatory V.A.C. is a portable suction device that can be powered by a separate battery pack or a low voltage power adapter. When activated, it applies continuous or intermittent negative pressure to a wound, promoting wound healing and drainage of fluids and/or infectious materials from the wound into a disposable collection canister.

The Ambulatory V.A.C. consists of a small housing that contains a vacuum pump and control system with a containment chamber for a disposable wound fluid collection canister, and sterile, single-use disposables. Accessories included in the Ambulatory V.A.C. system are separate battery packs, a battery charger, an optional modem and a carrying belt and pouch. The disposables consists of the wound fluid collection canister with an integral hydrophobic filter and an attached length of multi-lumen tubing, a wound dressing pad, and an overlying adhesive film that adheres to the skin surrounding the wound.

The Ambulatory V.A.C. pump housing comprises of a compact plastic molding that weighs approximately 500 grams and measures 15 cm x 11 cm x 6 cm. When in use, the pump can be placed inside the pouch and carried on the belt or, when the patient is stationary, the pump can be placed on a table or flat surface.

The pump is turned ON by applying power either by the battery pack or the low voltage adapter. An LCD and membrane keypad on the top of the unit becomes active when power is applied. Operating parameters are selected using the LCD and keypad. The LCD is also used during operation to display the current negative pressure being applied and any alam condition messages.

The Ambulatory V.A.C. automatically stores the operating parameters from the previous therapy session. When the Ambulatory V.A.C. unit is initialized, the LCD displays the phrase "NEW PATIENT" at the top the display with "NO" and "YES" beneath it. "NO" is displayed over the left-arrow key and "YES" is displayed over the right-arrow key. Both arrow keys are located directly below the LCD. If the left-arrow key is pressed, for NO, the phrase "Will operate at previous settings" is displayed on the LCD. The operating parameters for the current therapy session remain as they were for the previous session. The THERAPY ON/OFF key, located to the left of the LCD, is then pressed to begin therapy.

If the right-arrow key is pressed for YES, indicating a new patient, the phrase "USING DEFAULTS" is displayed on the LCD. The user must specify whether default or user-selected parameters are to be used for the current therapy session. To use default parameters and begin operation, the THERAPY ON/OFF key is pressed and the unit will operate at default settings of 125mmHg with continuous therapy. To specify new parameters, the SELECT OPTIONS key, located to the right of the LCD, is pressed. The LCD displays the words "VAC TARGET =" followed by a number representing the current vacuum pressure setting. Pressing the right-arrow key increases the current setting in 25mmHg increments, while pressing the left-arrow key When the desired vacuum pressure is displayed, the decreases it in 25mmHg increments. SELECT OPTIONS key is again pressed to save the setting.

The LCD next displays a choice of two operation modes: 1) continuous and 2) intermittent. The word "CONTIN." appears over the left-arrow key and the word "INTERMIT." appears over the right-arrow key. The currently selected mode flashes on and off. To select continuous mode (if it is not already the currently selected mode), the user presses the left-arrow key and then the THERAPY ON/OFF key, to begin operation. If the continuous mode is already selected, the user simply presses the THERAPY ON/OFF key. To select the intermittent mode (if it is not already the currently selected mode), the user presses the right-arrow key and then the THERAPY ON/OFF key to being operation of therapy ON for 5 minutes and OFF for 2 minutes. The Ambulatory V.A.C. runs continuously until the THERAPY ON/OFF key is again pressed.

The Ambulatory V.A.C. pump has the following Alarm functions:

• · Canister Full
• · Dressing Leak
• · Battery Low

Each alarm condition is accompanied by an appropriate LCD message and an audible alarm that can be silenced by correcting the condition or pressing the therapy button.

SINGLE USE DISPOSABLES

• · wound fluid collection canister (50 ml) with integral filter and attached multilumen tube ( flexible medical tubing, meets USP Class VI criteria)
• polyurethane foam pad .
• plastic adhesive overlay .
• · Flexible tube to dressing connector

The wound fluid collection canister is a disposable chamber made of translucent plastic used for receiving fluids emitted from a wound. The canister includes a plastic cap that firmly locates the canister inside the pump housing. The canister is also graduated to allow the user to easily view and measure the volume of wound fluids within the canister.

The collection canister has two parts which locate on spigots inside the pump housing. One spigot is used for applying a vacuum down the central bore of the multilumen tube. The other spigot locates in the second port which in turn is connected to the outer lumen of the tube and is used for sensing negative pressure at the wound site. A 0.2 micron hydrophobic membrane filter is mounted over the canister outlet. Fluid is drawn up through the central bore of the tube and into the canister. When the canister becomes full, the face of the filter is occluded and the negative pressure is reduced at the wound site which triggers the canister full alarm.

The disposable wound pad is fabricated from either polyurethane or PVA foam. In order for wound fluids to be communicated into the canister, the pad must be secured over the wound. This is accomplished by applying a plastic adhesive drape over the wound pad that gently adheres to the skin surrounding the wound. With the wound area sealed, vacuum pressure is transmitted to the wound when the suction pump is activated.

The provided text describes a medical device, the Ambulatory V.A.C., which is a portable suction device used for wound healing. However, the document is a 510(k) summary for premarket notification and does not contain details about a clinical study with acceptance criteria and reported device performance in the way typically found for AI/ML-based devices.

This document focuses on demonstrating substantial equivalence to a predicate device (V.A.C. Plus, 510(k) No. 945062) rather than presenting results from a performance study against specific acceptance criteria for a new device. The content is primarily a device description, indications for use, contraindications, precautions, and a comparison table of specifications between the Ambulatory V.A.C. and its predicate/similar devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample size for test set, data provenance, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, or how training ground truth was established, as this information is not present in the provided 510(k) summary.

The closest information available related to "performance" is the specifications comparison chart which lists physical and functional characteristics of the device and comparable devices. These are not "acceptance criteria" in the sense of a clinical or performance study outcome but rather design specifications.

However, I can extract information related to the device's specifications, which act as de-facto performance metrics for a hardware device in the context of substantial equivalence.

Here's an attempt to derive some of the requested information based on what is available, acknowledging the limitations mentioned above:

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

Since this is a 510(k) summary demonstrating substantial equivalence for a physical medical device, not a performance study of an AI/ML algorithm, the "acceptance criteria" are implied by the similarity to the predicate device and relevant industry standards for powered suction pumps. The "reported device performance" are the physical and functional specifications of the Ambulatory V.A.C.

The following information cannot be extracted from the provided text as it pertains to clinical/performance studies, particularly for AI/ML devices, which is not the nature of this 510(k) submission for a physical medical device.

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

• Not Applicable. The document is a 510(k) summary for a physical medical device, not a data-driven AI/ML device. It relies on design specifications and performance characteristics, comparing them to a predicate device, rather than a clinical "test set" with patient data.

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. No "ground truth" establishment by experts in the context of a test set is described.

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

• Not Applicable. No test set or adjudication method is described.

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 is a hardware device, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a hardware device.

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

• Not Applicable. No "ground truth" of this nature is used for this type of device submission. The "ground truth" for a physical device is its functional specifications and adherence to design parameters compared to established medical device standards and predicate devices.

8. The sample size for the training set

• Not Applicable. No training set is described for a hardware device.

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

• Not Applicable. No training set or ground truth establishment is described.

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