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The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.

The Acare Suction Unit, model ASU-200 is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. The device is a rugged, compact and portable electrically-operated medical suction device, designed for multi-source powering from AC (External 100V- 240 V) or DC (External 12V DC) mains supply or internal rechargeable battery, and is ideally suited for field, transport and hospital/clinical use applications.

The Acare canister is an accessory to the Acare Pump and the removed body fluids are collected in it. The Acare Pump is an AC powered oil-less positive displacement pump capable of delivering up to 600 mmHg of vacuum to draw fluid and small particles. The Acare Pump has a plastic casing fitted with a power (ON/OFF) button, power indicator, one suction adjustment knob, a suction gauge and a canister holder. The Acare canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The Acare canister should be placed in the in-built canister holder and connect the Acare canister with the Acare Pump via the connectors of the canister tubing prior to use.

The provided text is a 510(k) Premarket Notification for the Acare Suction Unit, model ASU-200. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy or diagnostic accuracy through studies with ground truth established by experts.

Therefore, the information requested about acceptance criteria and studies (especially those involving expert ground truth, sample sizes for training/test sets, MRMC studies, or standalone performance of an AI algorithm) is not applicable to this type of device and submission.

The document describes performance testing conducted to ensure safety and functionality in comparison to predicate devices, but this is engineering and compliance testing, not a clinical study to assess diagnostic performance.

Here's an attempt to populate the table and address the questions based solely on the provided text, acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance

Details of the "Study" (Non-Clinical Testing) that proves the device meets acceptance criteria:

The "study" described is a series of non-clinical, engineering, and compliance tests. The goal was to demonstrate that the Acare Suction Unit, model ASU-200, is as safe and effective as its predicate devices, primarily through meeting established international and national standards for medical electrical equipment.

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

• Sample Size: Not applicable. These were engineering and compliance tests performed on the device itself, not on a dataset or patient samples. Typically, one or a few units are tested to demonstrate compliance.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting to specific engineering standards.

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

• Not applicable. There was no ground truth established by experts in a clinical or diagnostic sense. The "ground truth" was the compliance with published international and national standards (e.g., IEC 60601-1-2, ANSI/AAMI ES 60601-1, ISO 10079-1, IEC 60529). Compliance was assessed by engineering testing.

4. Adjudication method for the test set:

• Not applicable. This was not a study requiring adjudication of expert interpretations. Compliance was determined by whether the device's performance met the specified thresholds and requirements of the safety and performance standards.

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 a suction unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This refers to AI algorithm performance studies, which are not relevant to a medical suction unit.

7. The type of ground truth used:

• Not applicable in the conventional sense of medical imaging/diagnostic studies. The "ground truth" for this submission was the defined requirements and specifications within the referenced international and national safety and performance standards (e.g., maximum vacuum pressure, flow rate thresholds, EMC limits, electrical safety parameters, IP code requirements).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

• Not applicable. As above, no training set or associated ground truth was established for this device.

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Finger Type Pulse Oximeter, AB-F1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult patients use.

Handheld Pulse Oximeter, AH-S1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.

Handheld Pulse Oximeter, AH-M1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.

Not Found

The provided document is limited to the FDA 510(k) clearance letter and Indications for Use statements for three pulse oximeters (AB-F1, AH-S1, and AH-M1). It confirms that the devices are substantially equivalent to previously marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria or the specifics of a study proving device performance against those criteria. This type of detailed study information (performance data, sample sizes, ground truth establishment, expert qualifications, etc.) is typically found in the 510(k) submission's safety and effectiveness section, which is not part of this publicly available clearance letter.

Therefore, I cannot extract the requested information from the provided text. I can only confirm that:

• Device Names: Finger Type Pulse Oximeter, AB-F1; Handheld Pulse Oximeter, AH-S1; Handheld Pulse Oximeter, AH-M1
• Intended Use: Spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities and home care environment.
• Patient Population: AB-F1 for adult patients. AH-S1 and AH-M1 for adult, pediatric, and neonatal patients.
• Regulatory Status: Substantially equivalent (510(k) K111617) to a predicate device.

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