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The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.

This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.

The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.

Here's an analysis of the acceptance criteria and study information for the MINISCAV™ device, based on the provided document:

The document describes a 510(k) premarket notification for the MINISCAV™ waste gas evacuation apparatus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical efficacy studies in the same way a PMA would. Therefore, the "study" mentioned here refers primarily to the non-clinical testing performed to show the device meets its performance specifications and is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format for each performance aspect. Instead, it describes various tests and what they demonstrated. I've extracted the implied criteria and the reported performance from the "Non-Clinical Testing Summary" and "Technology, Construction, Performance" sections.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of a number of devices tested for each non-clinical test. It mentions "continuous running," "real-time testing of the complete unit," and "testing demonstrates" but doesn't give precise quantities like "n=X devices were tested." This is common for this type of non-clinical device testing, where the focus is on design verification and validation rather than statistical sampling of many units.
• Data Provenance: Not explicitly stated, but given it's a device manufactured by Sedation Systems LLC in Florida, the non-clinical testing was likely conducted in the USA or by a contracted lab. The document does not indicate if the data is retrospective or prospective; for non-clinical lab testing, this distinction is less relevant than for clinical studies. It's direct testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

This information is not applicable and not provided in the document.

The "test set" here refers to the physical MINISCAV™ devices (or prototypes/components) undergoing non-clinical validation. There isn't a "ground truth" established by experts in the context of an AI/human-in-the-loop study. The "ground truth" for the performance specifications is determined by established engineering standards (e.g., AAMI/ANSI/ES60601-1, IEC 60601-1-2) and the manufacturer's own design specifications, which are then validated through objective measurements (e.g., pressure gauges, flow meters, electrical testers, timers).

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or expert review processes, especially for establishing ground truth for diagnostic AI, which is not the nature of this submission. The non-clinical tests involve objective measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for diagnostic medical devices, especially those using AI, to compare the performance of human readers with and without AI assistance on a set of clinical cases. The MINISCAV™ is a waste gas evacuation apparatus, a piece of mechanical/electrical equipment, not a diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable.

The MINISCAV™ is a physical medical device (vacuum pump), not an algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate. Its operation is standalone in the sense that it mechanically performs its function without a human intervening in its internal mechanism once activated, but it is operated by a human in a clinical setting.

7. Type of Ground Truth Used

As discussed in point 3, the "ground truth" here is based on engineering and performance specifications derived from international standards (AAMI/ANSI/ES60601-1, IEC 60601-1-2) and the functional requirements for waste gas scavenging. This is objectively measurable data from physical testing, not expert consensus on clinical cases, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable.

This device does not involve a "training set" in the context of machine learning or AI. The MINISCAV™ is a designed and engineered product, not a system that is "trained" on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

As there is no training set for an AI/ML algorithm, there is no ground truth established for it.

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