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Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours.

HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.

Environment of use - clinical setting including hospital, sub-acute, pre-hospital and home

For patient with Tidal Volumes > 300 ml.

The subject device is provided in two (2) configurations.

• Filter only ●
• . HME / Filter combination
• The common features are:
  • Standard conical 15 mm / 22 mm fittings for connections
  • Female luer lock port for gas sampling for end-tidal CO2 ●

The provided text describes a 510(k) premarket notification for a medical device called "Altera Filter and HME/Filter". It details the device's characteristics, indications for use, and a comparison with a predicate device, including performance data from nonclinical testing.

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

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to nonclinical testing of a physical medical device. It does not mention clinical trials or studies involving human subjects in the typical sense of a "test set" for AI algorithms. The "tests" refer to laboratory-based performance and biocompatibility assessments of the device itself.

• Sample Size for Test Set: The sample sizes for each specific test (e.g., number of filters tested for flow resistance, BFE, etc.) are not explicitly stated in the provided text.
• Data Provenance: The document is a submission to the U.S. Food & Drug Administration (FDA) by Meditera Tibbi Malzeme San. ve Tic. A.S., located in Turkey. The tests are nonclinical, laboratory-based. The text does not specify where the testing laboratories are located, though it implies the data was generated to support a submission in the US. The data is nonclinical/laboratory test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the provided document. The "tests" performed are objective measurements of the device's physical and performance characteristics against established international standards (ISO, ASTM). Ground truth in this context is defined by the requirements of these standards and the measured physical properties, not by expert human interpretation like in medical imaging.

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

This question is not applicable. Adjudication methods are typically associated with resolving discrepancies in expert interpretations (e.g., when multiple radiologists review images). For objective nonclinical device performance tests, the results are measured directly against defined criteria.

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

This question is not applicable. The document describes a physical medical device (Altera Filter and HME/Filter) and its nonclinical performance testing. It does not involve any AI components, human readers, or image interpretation.

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

This question is not applicable. The device is a physical breathing circuit filter, not an algorithm.

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

For this nonclinical device, the "ground truth" for the test results is based on:

• Established International Standards: ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials) standards define the test methodologies and acceptable performance ranges.
• Predicate Device Equivalence: Many acceptance criteria are stated as "Equivalent to a predicate," indicating that the performance of the new device is compared against the known performance of a legally marketed, similar device (Zhejiang Haisheng Medical Device Co. Ltd - K151498).
• Direct Physical Measurements: The performance criteria (e.g., flow resistance, filtration efficiency, moisture output, burst pressure) are determined through direct, objective physical measurements in a laboratory setting.

8. The sample size for the training set

This question is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."

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

This question is not applicable, as there is no training set for a physical device.

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The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.

The Altera Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line which is provided in 3 different lengths: 2, 2.5, and 3 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends.

The gas sampling line connects from a port in a circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the sampling port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are in the host device, which pull the gas from the sampling port to the host device for gas monitoring.

This document is a 510(k) premarket notification for a medical device, specifically "Altera Gas Sampling Lines." It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials as might be seen for novel technologies or higher-risk devices.

Based on the provided text, the device is a simple, single-use, disposable component (a gas sampling line) that connects a breathing circuit to an expired gas monitor. There is no evidence in this document of AI or machine learning components, nor any mention of a study involving human readers improving with AI assistance. Therefore, the questions related to AI performance, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this submission.

Here's an analysis of the provided information concerning the acceptance criteria and the study that proves the device meets them, primarily focusing on the device's physical and functional performance, as that is the scope of this 510(k).

Acceptance Criteria and Device Performance for Altera Gas Sampling Lines

Given the nature of this device (a gas sampling line), the "acceptance criteria" are primarily related to its physical and functional performance characteristics, ensuring it performs its intended function (transporting gas samples) safely and effectively, and equivalently to the predicate device. The "study" proving this involves various non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The table below summarizes the key performance attributes tested and the results presented in the document. The general acceptance criterion for these tests is that the proposed device (Altera GSL) performs comparably or better than the predicate device (Vyaire Vital Signs) and meets relevant industry standards.

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

• Sample Size: The document does not specify the exact sample sizes for each physical and functional test (e.g., how many gas sampling lines were tested for flow resistance, leakage, or mechanical properties). It broadly states "Performance Testing" was completed. For a 510(k) of this type, standard engineering and quality control practices would dictate appropriate sample sizes for manufacturing verification, but these details are not provided in the summary document.
• Data Provenance: The tests would have been performed by the manufacturer, Meditera Tibbi Malzeme San. ve Tic. A.S., or their designated testing facilities. The country of origin for the manufacturing is Turkey (Izmir). The data provenance is retrospective in the context of the 510(k) submission, meaning the tests were completed and the data collected prior to the submission for regulatory review. There is no mention of prospective clinical data.

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

• Not Applicable. As previously stated, this device is a physical component without AI/ML. "Ground truth" in this context refers to engineering specifications and performance standards (e.g., ISO standards for luer fittings, flow resistance measurements). These are established through scientific principles and engineering testing, not by expert human interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Not Applicable. Since there are no human experts evaluating data (as in clinical trials or AI performance evaluations), there is no need for an adjudication method. Test results are based on objective measurements against engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is relevant for evaluating the impact of AI on human performance (e.g., radiologists interpreting images). This device is a simple medical accessory, not an AI software.

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

• Not Applicable. This device does not involve an algorithm. The "standalone performance" refers to the physical and functional integrity of the gas sampling line itself, as detailed in the performance testing section.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering specifications, international performance standards (e.g., ISO 80601-2-55 for leakage, ISO 80369-7 for luer fittings), and comparative performance data against a legally marketed predicate device. The tests performed include:
  • Flow resistance
  • Accelerated aging (for 3-year shelf-life)
  • Mechanical testing (luer fitting properties: fluid leakage, air leakage, stress cracking, separation force, unscrewing torque, resistance to overriding)
  • Air leakage (general)

8. The Sample Size for the Training Set

• Not Applicable. This document is for a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. No training set exists for this type of device.

Conclusion from the document:

The manufacturer concluded, and the FDA agreed in the 510(k) clearance, that the "Altera Gas Sampling Lines" are substantially equivalent to the predicate device (Vyaire Vital Signs Gas sampling Lines) based on a comparison of intended use, principle of operation, technological characteristics, and non-clinical performance testing. The performance testing ensured the device met applicable standard requirements and did not raise new questions of safety or effectiveness compared to the predicate.

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