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510(k) Data Aggregation
(400 days)
The Salter Labs High Volume CPAP Cannula System is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing adult patients within a homecare and hospital environment.
The Salter Labs High Volume CPAP Cannula System is a microprocessorcontrolled, compressor-based system that generates positive airway pressures from 4 cmH2O up to 12 cmH2O. The device is intended for use with a Salter Labs connector hose that is used to connect the device to the patient interface: the Salter Labs High Volume CPAP Cannula. The device is designed to provide heated and moist air to the patient through the cannula system, rather than using a nasal or CPAP Mask.
The provided text describes the Salter Labs CPAP High Flow Cannula System, but it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving device performance.
Specifically, the text mentions "Extensive laboratory and clinical testing was done to compare performance of the Salter Labs CPAP System to a predicate device, and was found to be very effective in treating OSA." and "Based upon laboratory and clinical use, it has been determined by the patients using this configuration that it offered improved patient comfort and resulted in a restful nights sleep for those studied." However, it does not provide specific acceptance criteria, study methodologies, sample sizes, ground truth details, or statistical results from these tests.
Therefore, I can only fill in the parts for which information is available and will note where data is missing.
Acceptance Criteria and Device Performance Study for Salter Labs CPAP High Flow Cannula System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specific Targets/Metrics) | Reported Device Performance |
|---|---|
| Not specified in the provided text. | "very effective in treating OSA" |
| "offered improved patient comfort" | |
| "resulted in a restful nights sleep for those studied" | |
| Pharyngeal pressurization | Up to 12 cmH2O (achieved by the device) |
| Airflow to patient | 60 lpm (achieved by the device) |
| Heated and humidified airflow | Achieved (to prevent drying of nasal and throat tissues) |
| Prevention of flaccid tissue collapse | Demonstrated through pressurization and mild turbulence |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The text mentions "those studied" implying a clinical study, but no number is provided.
- Data Provenance: The text refers to "laboratory and clinical testing" but does not specify the country of origin or whether the data was retrospective or prospective. Given the 510(k) submission is to the FDA, it is likely the clinical testing was conducted in the US, but this is not explicitly stated. It implies prospective clinical data due to comparing performance to a predicate and patient feedback after use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, the provided text does not describe an MRMC comparative effectiveness study. The comparison mentioned is between the Salter Labs CPAP System and a predicate device in terms of overall performance and patient comfort, not specifically how human readers improve with AI assistance. The device itself is a piece of medical hardware, not an AI-driven diagnostic or assistive tool in the typical sense that would involve human readers interpreting outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The text describes the performance of the device (Compressor Assembly, Tubing Assembly, CPAP Cannula), which operates autonomously to deliver therapy. In this context, the device's performance for delivering positive airway pressure and humidified air would be considered "standalone" as it doesn't involve a human operator in its core function of delivering therapy. However, this is not an "algorithm only" study as might be conducted for an AI diagnostic tool.
7. The type of ground truth used
- The ground truth for effectiveness ("very effective in treating OSA") and patient experience ("improved patient comfort," "restful nights sleep") appears to be based on:
- Clinical Efficacy/Outcomes: Implied by "very effective in treating OSA," likely measured through physiological parameters or symptom resolution.
- Patient Reported Outcomes (PROs): Implied by feedback on "improved patient comfort" and "restful nights sleep."
- Physiological Measurements: Specifically, "measured pharyngeal pressurization of up to 12 cmH2O" is a direct measurement of the device's physical effect rather than an expert consensus per se.
8. The sample size for the training set
- Not applicable/Not specified. The device is a hardware system, not an AI model that requires a training set in the conventional sense. The "training" in this context refers to engineering and design iterations, not algorithmic learning.
9. How the ground truth for the training set was established
- Not applicable/Not specified as there is no mention of a "training set" for an AI model. The device's design and performance were likely optimized through engineering tests and possibly pilot human trials, but these are not described as a "training set" with ground truth in the context of machine learning.
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