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The Digital MXR-D Flowmeter is intended for use in nitrous oxide/oxygen sedation systems for the delivery of a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.

The proposed Digital MXR-D Flowmeter is a modification of the MXR 2000 Flowmeter that was cleared for marketing in the U.S. as K923781. The major modification to the MXR 2000 Flowmeter to produce the proposed Digital MXR-D Flowmeter is the addition of an electronically controlled digital display to the control panel of the cabinet mount version. The electronics incorporated in the Digital MXR-D Flowmeter function as follows:

• Turn flow and clectronics on/off and display start-up information .
• Display nitrous oxide (N2O) percentage and total flow .
• . Display information and instructions (i.e. fault conditions and error codes)
• . Provide an audible signal for certain fault conditions.

The provided text describes a 510(k) summary for a medical device called the "Digital MXR-D Flowmeter." However, it is important to note that this document does not contain the detailed acceptance criteria or the specific study data typically found in a clinical trial report or a comprehensive validation study.

The information provided is a premarket notification to the FDA, which outlines the device description, intended use, and a general statement about performance testing. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed statistical analysis of performance against specific acceptance criteria.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy percentages, error rates with confidence intervals) are explicitly stated or reported in the provided 510(k) summary.

The summary states:
"Testing conducted to evaluate the functional performance and safety of the proposed Digital MXR-D Flowmeter includes software and hardware verification and validation and electrical safety and electromagnetic compatibility. The test results confirm that the proposed Digital MXR-D Flowmeter performs within established specifications and is safe and effective for use as a dental analgesia gas machine."

This is a general statement of compliance, not a presentation of specific criteria and corresponding performance data. The "established specifications" are not detailed.

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

• Sample Size for Test Set: Not specified. The document mentions "software and hardware verification and validation" and "electrical safety and electromagnetic compatibility" testing, but it does not provide any specifics about the number of test cases, measurements, or samples used in these tests.
• Data Provenance: The document describes engineering and safety testing. It does not refer to clinical data (retrospective or prospective) from human subjects or patient samples. The testing appears to be laboratory-based and engineering-focused.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Given that the testing described is primarily engineering and functional validation (software, hardware, electrical safety), the concept of "ground truth" derived from clinical experts in the context of diagnostic accuracy is not directly applicable here. The "experts" would likely be engineers, quality assurance personnel, and regulatory specialists who assess compliance with technical specifications and standards. Their number and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set

Since the testing is primarily technical verification and validation against established engineering specifications and safety standards, a clinical adjudication method (like 2+1 or 3+1 for ground truth in image analysis) is not relevant or described in this document. The assessment would involve technical reviews and comparisons to specifications.

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

An MRMC study is typically conducted for diagnostic or screening devices where human readers interpret results (e.g., radiologists reading medical images). The Digital MXR-D Flowmeter is a gas machine for analgesia, not a diagnostic imaging device. Therefore, a MRMC comparative effectiveness study was not conducted or reported for this device in the provided text. The concept of "human readers improve with AI vs without AI assistance" is not applicable to a flowmeter.

6. Standalone Performance Study

The testing described ("software and hardware verification and validation and electrical safety and electromagnetic compatibility") represents the standalone performance evaluation of the device's technical functions. However, detailed results (e.g., accuracy of flow rate display, N2O percentage display error, response time) are not quantitatively reported. The statement "performs within established specifications" is the summary of this standalone performance, but the specifics are not given.

7. Type of Ground Truth Used

For the engineering and safety tests mentioned, the "ground truth" would be established by:

• Established Specifications: The device's design specifications for flow rate accuracy, N2O concentration accuracy, electrical safety limits (e.g., IEC standards), and electromagnetic compatibility limits.
• Reference Standards/Equipment: Calibrated measurement devices used to verify the outputs of the flowmeter.
• Software Requirements Specifications: Documents detailing the expected behavior of the software.

This is not 'expert consensus, pathology, or outcomes data' in the clinical sense, but rather engineering and regulatory compliance truth.

8. Sample Size for the Training Set

The Digital MXR-D Flowmeter is a mechanical and electronic device with a digital display, not a machine learning or AI-based system. Therefore, the concept of a "training set" for an algorithm is not applicable. The device operates based on fixed engineering principles and programmed logic, not learned patterns from data.

9. How Ground Truth for the Training Set Was Established

As stated above, there is no training set for this type of device.

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For control of vacuum flow in a gas scavenging apparatus, used as an accessory in Porter Instrument Company's Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines (flowmeters).
The intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus.
The intended use of the modified device, as described in our labeling, has not changed as a result of the modifications.

The automatic interlock switch (AVS) is a device intended to assure that analgesic gases cannot be turned on unless an activated scavenging system is present.

This 510(k) summary describes a traditional medical device (Automatic Vacuum Switch - AVS), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing are not applicable. I will address the applicable criteria based on the provided document.

Acceptance Criteria and Device Performance Study for the Automatic Vacuum Switch (AVS)

This document describes the validation of the Automatic Vacuum Switch (AVS) for use as an accessory in Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines. The primary purpose of the AVS is to interlock with the analgesic gas supply, ensuring that these gases cannot be activated unless an activated scavenging system is present.

The study aimed to demonstrate the device's safety and effectiveness and its substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size in terms of a number of devices or data points from an independent clinical study. The testing described appears to be primarily verification and validation (V&V) testing performed during the device development and manufacturing process on production units. This includes:

• Manufacturing Functional Tests: Applied to "All finished products." This implies 100% inspection during manufacturing.
• Design Validation Testing: Risk assessment, backpressure, delivery and vacuum flow, leak testing, system testing, and simulated use testing would have been performed on a representative sample during the design validation phase. The exact number of units or test iterations is not specified in this summary.
• Data Provenance: The data is generated internally by Porter Instrument Company, Inc. and is prospective in nature (i.e., created specifically for the device's validation and ongoing manufacturing quality control). No country of origin for a clinical dataset is applicable as a clinical study is not described.

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

N/A. This medical device is a mechanical accessory; its "ground truth" is based on its physical functionality and adherence to engineering specifications and safety standards rather than expert-labeled diagnostic data. Technical experts (engineers, quality assurance personnel) within Porter Instrument Co. Inc. would have defined and assessed these criteria.

4. Adjudication Method for the Test Set

N/A. Not applicable for a mechanical device undergoing V&V testing. Results would be pass/fail based on pre-defined specifications, not expert adjudication of subjective outcomes.

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

N/A. This is not an AI/ML device, and no MRMC study or human reader improvement analysis was conducted or is relevant.

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

N/A. This is a traditional mechanical device; there is no "algorithm only" performance to evaluate. The device functions as intended when installed and operated correctly.

7. The type of ground truth used

The "ground truth" for the AVS is based on engineering specifications and functional requirements. This includes:

• Design Specifications: Detailed parameters for backpressure, flow rates, leak tolerances, and activation logic.
• Safety Standards: Compliance with relevant medical device safety standards and risk assessment outcomes (FMEA, Hazard Analysis).
• Intended Use Definition: The device successfully performs its specific function as an interlock for gas scavenging systems.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; therefore, there is no "training set" in the context of machine learning.

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

N/A. Not applicable for a non-AI/ML device.

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