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The intended use of the Sechrist Model 3500CP-G Air/Oxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.

The Sechrist Model Series 3500CP-G Air/Oxygen Mixer is a precision pressure regulation and proportioning device which is intended to mix medical grade air and medical grade oxygen. The mixer receives pressurized air and oxygen, at a nominal 50 psi, via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi, providing the pressures are within 20 psi of one another. Two outlets for the mixed gas are provided. The air/oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses.

The provided 510(k) summary for the Sechrist 3500CP-G Air/Oxygen Mixer does not contain information about a study conducted to prove the device meets specific acceptance criteria based on numerical performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through adherence to established quality system standards and verification of the device's intended function.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of submission.

Here's a breakdown of the available information and how it relates to your request:

Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided text):

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

   • Not applicable/Not provided. This 510(k) relies on demonstrating substantial equivalence to predicate devices and adherence to design/manufacturing standards, rather than a clinical performance study with a test set of data.

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

   • Not applicable/Not provided. No specific "test set" with "ground truth" derived from experts is mentioned for this type of submission.

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

   • Not applicable/Not provided.

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:

   • Not applicable. This is a submission for a hardware device (gas mixer), not an AI/software device that would involve human readers or AI assistance.

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

   • Not applicable. This is a hardware device.

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

   • Not applicable/Not provided in the context of a performance study. The "ground truth" for this device's performance would be its ability to physically mix gases within specified tolerances, which would be verified through engineering testing and quality control during manufacturing, not typically a "ground truth" established by experts in a clinical study sense for a 510(k) submission like this.

7. The sample size for the training set:

   • Not applicable/Not provided. Training sets are relevant for machine learning algorithms, which is not the case here.

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

   • Not applicable/Not provided.

Summary of the 510(k) Approach:

The 510(k) for the Sechrist 3500CP-G Air/Oxygen Mixer demonstrates its acceptability through:

• Substantial Equivalence: Comparing the device's design, indications for use, and technological characteristics to legally marketed predicate devices (K802226, K992503, K841789, K863902, K901253). The key "study" here is the comparative analysis showing that the new device is functionally the same or very similar to existing cleared devices.
• Adherence to Standards: Compliance with established national and international quality management system standards (ISO 9001, ISO 13485, EN 46001, 21 CFR 820). This implies that the design, manufacturing, and performance verification processes are robust, reducing the need for a separate detailed clinical performance study in this context.
• Device Description: A detailed description of the device's function and operational parameters, which are presumed to be consistent with those of the predicate devices.

This type of submission typically relies on design verification and validation testing performed by the manufacturer, which demonstrates the device meets its own specifications, rather than a clinical study establishing performance against a "ground truth" in a patient population. These internal tests would verify parameters like pressure regulation accuracy, mixing ratio accuracy, and flow characteristics, but the 510(k) summary itself does not detail the results of these internal tests.

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