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The Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.

The SOFTECH Plus ETCO2 Cannula is a non-sterile disposable, single patient use device that acts as an adjunct to oxygen therapy with its primary function providing a means to deliver low flow oxygen, while sampling part of the patients exhaled gas. The SOFTECH Plus ETCO2 Cannula has a split nare blank with oxygen delivery through one nasal prong while allowing sampling of the patient's exhaled gas from the corresponding nasal prong.

The provided text is a 510(k) summary for the SOFTECH® Plus ETCO2 Cannula, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of diagnostic accuracy or a similar performance claim.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed from the given text because the study presented is primarily for demonstrating substantial equivalence based on physical and performance characteristics, particularly related to shelf-life and a material change, rather than a clinical performance study with diagnostic endpoints.

However, I can extract and infer information where possible based on the provided text.

Here's an analysis of the provided text in relation to your request:

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

The document doesn't explicitly list "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., sensitivity, specificity thresholds). Instead, it describes performance testing to ensure the device performs comparably to its predicate after a design change (shelf-life addition and material change). The implied acceptance criterion for these tests is "substantially equivalent performance" to the predicate device.

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

• Sample Size: The document does not specify the sample size for the "test set" in terms of number of devices or number of data points collected during the ETCO2 and connector performance testing.
• Data Provenance: Not specified. The testing was likely conducted by the manufacturer, Teleflex Medical, Inc., which has an address in Research Triangle Park, NC, USA. The study design appears to be a prospective engineering/performance test rather than a clinical study.

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 is not applicable. For engineering performance tests like ETCO2 sampling and connector strength, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" or reference standard would be the performance of the predicate device or a defined physical standard.

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

Not applicable. This type of adjudication is typically used in clinical studies involving interpretation by multiple readers.

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

Not applicable. This is not an AI-based diagnostic device, nor is it a study involving human readers.

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

Not applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its physical characteristics and gas sampling capabilities are tested directly.

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

Not explicitly stated in the context of "ground truth" for diagnostic purposes. However, for the performance tests:

• ETCO2 Performance: The "ground truth" would likely be the known CO2 concentration of gases being sampled or the performance of the predicate device under similar conditions. This involves direct measurement and comparison.
• Connector Performance: The "ground truth" would be established engineering standards for leak and disconnection forces.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning/AI device.

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

Not applicable. There is no "training set."

Summary of Study:

The studies described are engineering and performance validation tests to support a 510(k) submission for a modified medical device, the SOFTECH® Plus ETCO2 Cannula. The purpose was to demonstrate that adding a 1-year shelf-life and changing the durometer of the oxygen connector material did not negatively impact the device's performance compared to its legally marketed predicate.

• Study Type: Performance validation testing (not a clinical or diagnostic accuracy study).
• Key Tests:
  • ETCO2 performance at various oxygen flow rates after simulated 1-year aging (per ASTM F1980-07).
  • Connector performance (leak and disconnection testing) after a material change.
• Conclusion: The device was found to be "substantially equivalent" to the predicate, meaning its performance was comparable and the changes did not raise new questions of safety or effectiveness.

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