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The Philips Respironics Reusable Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and multi-patient use in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for patients weighing over 10 kg (22lbs). It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics A-Series System One Heated Humidifier.

The Philips Respironics Reusable Heated Tubing warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Philips Respironics Reusable Heated Tubing is disinfected between patients through one of the following chemical methods: Cidex. or Cidex OPA. It is alternatively disinfected through the following thermal method: 75 °C for 30 minutes. The Philips Respironics Reusable Heated Tubing has a proprietary connector with two locking tabs (unchanged) that makes it compatible with the Philips Respironics System One Humidifier (K113068) and Philips Respironics A-Series System One Heated Humidifier (K121623).

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria in the same way one would for a novel algorithm.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (Philips Respironics Reusable Heated Tubing), the acceptance criteria are not presented as numerical thresholds for an AI algorithm's performance (e.g., sensitivity, specificity). Instead, they are related to meeting established medical device standards and demonstrating functionality and safety after reuse and disinfection processes. The "reported device performance" is framed as successfully meeting these standards and maintaining function.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the conventional sense of an AI or diagnostic device evaluation. Instead, it refers to "extensive performance testing" and testing under "worst-case conditions" for cleaning, disinfection, and residue removal. These are bench tests, not patient studies with a data cohort.
• Data Provenance: The data is generated from bench testing within a laboratory setting, not from human patient data. There is no mention of country of origin of data or whether it is retrospective/prospective, as it is a non-clinical, in-vitro (simulated) evaluation.

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

Not applicable. This is a medical device (heated tubing) seeking 510(k) clearance, not an AI or diagnostic algorithm requiring expert-established ground truth from images or clinical data. The "ground truth" (i.e., whether the device performs as intended and is safe) is established through adherence to engineering standards, performance metrics, and successful completion of cleaning/disinfection validation.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no "test set" in the context of human data requiring expert adjudication. Performance is measured against physical and chemical standards.

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 diagnostic or assistive device, and therefore, no MRMC study or AI-assisted human reader improvement assessment was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Adherence to recognized industry standards: ISO 8185, IEC 60601-1, IEC 60601-1-2.
• Bench testing results: Demonstrating that the device maintains its mechanical, electrical, temperature control, and humidity control functionality after repeated cleaning and disinfection cycles.
• Validation of cleaning and disinfection processes: Showing that the specified methods effectively clean and disinfect the device, and that harmful residues are removed, according to AAMI TIR, ASTM, and ISO 10993 guidelines, and FDA guidance.
• Prior FDA clearance of materials: Patient-contacting materials were already deemed safe.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable. As this is not an AI or machine learning device, there is no training set or ground truth establishment method for such a set.

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