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The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmcter (1 to 12 I.PM). The device is a prescription device and is intended for use within the hospital or institutional environment.

SK Med M202 Mixer

This is an FDA premarket notification (510(k)) letter for the SK Med M202 Mixer. While it confirms clearance for the device, it does not contain the information requested about acceptance criteria and a study proving device performance.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and is thus cleared for marketing. It outlines regulatory requirements and general information but does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study (sample size, data provenance, ground truth, expert qualifications, adjudication methods, etc.).
• Information on MRMC comparative effectiveness or standalone algorithm performance.
• Training set details.

Therefore, I cannot provide the requested information from this document.

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The M201Plus Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves a device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or any information related to AI or multi-reader multi-case studies.

The document is a 510(k) premarket notification letter from the FDA to SK Med, Incorporated, concerning their SK Med M201 Plus Mixer, classified as a Breathing Gas Mixer. It primarily discusses the substantial equivalence determination of the device and regulatory compliance requirements.

Therefore, I cannot provide the requested table and information.

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The M201 Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "SK Med M201 Mixer." It is concerned with the regulatory approval of the device and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on confirming that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities, not on the technical performance study details.

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The SK Med Air Oxygen Mixer is intended for use with the infant and The SK Med An Oxygen Maxer in a hospital environment. Its indications for use are perilative population in a noops. I the Bird Low Flow Air Oxygen exactly the same as the predicate device i.e. the Bird Love Flow with exactly the same as the provide oxygen therapy in conjunction with:

• Oxygen Hoods
• · Resuscitation Bags
• Masks
• · Nasal Cannulas

The Air Oxygen Mixer is a pneumatically controlled low flow ( up to 30 lpm maximum flow ) air oxygen mixing device.

This document describes the SK Med Air Oxygen Mixer, which is a pneumatically controlled low-flow air-oxygen mixing device. The submission is a 510(k) premarket notification. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence to a predicate device, which is the Bird Low Flow Air/Oxygen Microblender. The study described is a series of bench and environmental laboratory tests designed to show that the new device is as safe and effective as the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a 510(k) submission are implicitly demonstrating that the new device is "as safe and effective" as the predicate device. For this device, this translates to:

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

• Sample Size: Not explicitly stated as a numerical sample size. The testing involved "extensive bench & environmental laboratory testing." For a device like this, the "test set" would likely be exemplar units of the device itself undergoing various performance and stress tests, rather than a human subject or clinical data set.
• Data Provenance: The testing was conducted in a "bench & environmental laboratory." There is no mention of country of origin for the data or whether it was retrospective or prospective, though bench testing is inherently prospective for the device being tested.

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

• This type of information is generally not applicable for a 510(k) submission based on bench testing of a device like an air oxygen mixer. Ground truth for device performance would be established through engineering specifications, regulatory standards, and comparison to the predicate device's known performance characteristics.
• The "experts" would be the engineers and technicians conducting the testing, validating the device's output against established standards or the predicate's performance. Their qualifications are not specified but would be implicit in their roles within the development and testing team.

4. Adjudication Method for the Test Set

• Not applicable in the context of clinical expert adjudication. For bench testing, adjudication would involve the engineers and quality control personnel reviewing test results against predefined specifications and predicate comparability data. There is no mention of a specific adjudication method like "2+1" for disagreement resolution.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging devices or AI-driven diagnostic tools involving human interpretation of data. The SK Med Air Oxygen Mixer is a mechanical device, and its evaluation does not involve "human readers" or "AI assistance" in this clinical sense.

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

• Not applicable. The device is a mechanical air-oxygen mixer, not an algorithm or AI system. Its performance is inherent in its physical and pneumatic operation.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering specifications, regulatory standards, and the established performance characteristics of the predicate device (Bird Low Flow Air/Oxygen Microblender). The primary goal was to show that the new device meets or exceeds these established benchmarks for safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. As a mechanical device whose performance is demonstrated through bench and environmental testing, there is no "training set" in the context of machine learning or AI. Prototyping and iterative design might involve multiple units, but this is distinct from a "training set."

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

• Not applicable, as there is no "training set" in the relevant context.

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