(17 days)
SLUMBERGEAR™ headgear is an accessory to a non-continuous ventilator (respirator), intended for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and/or home environments. The headgear is reusable and for single-patient use.
SLUMBERGEAR™ is a one-piece headgear with an integrated chinstrap used to secure externally placed masks, nasal pillows, and cannulas to the face of the patient, The headgear is a single strap that splits to wrap around the chin, the back of the head, and the top portions of the patient's head. Velcro® attached to each split portion of the headgear strap is used to fasten the headgear to the required respiratory device.
Here's an analysis of the provided text regarding the SLUMBERGEARTM device, focusing on the acceptance criteria and the study that proves the device meets them:
The provided document is a 510(k) Summary and an FDA substantially equivalent letter for the SLUMBERGEARTM headgear. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, pre-defined acceptance criteria with quantified performance metrics. As a result, the information differs significantly from a typical detailed performance study with explicit acceptance criteria often seen for AI/software devices.
1. Table of acceptance criteria and the reported device performance
For a 510(k) submission like this, "acceptance criteria" are generally framed around demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented focuses on user satisfaction and safety/effectiveness in comparison to existing devices rather than meeting specific quantitative thresholds.
| Acceptance Criteria (Implied by Substantial Equivalence for a 510(k)) | Reported Device Performance |
|---|---|
| Safety: Device is safe for intended use. | "SLUMBERGEAR™ was found to be safe and effective." |
| Differences (seamless design, closures) "add to the effectiveness and safety of the headgear." | |
| Effectiveness: Device performs its intended function effectively. | "SLUMBERGEAR™ was found to be safe and effective." |
| Differences "add to the effectiveness and safety of the headgear by stabilizing the respiratory device to help eliminate shifting, air escape and mouth breathing during sleep." | |
| Intended Use Equivalence: Same intended use as predicate devices. | "the same intended use" as predicate devices (K021861 and K031047). |
| Technological Characteristics Equivalence: Similar operating principles, technology, materials, and manufacturing process to predicate devices, with any differences not raising new safety or effectiveness concerns. | "the same operating principles," "the same technology, same or similar materials in contact with patient's skin," "the same type of manufacturing process." Differences (one-piece design, integrated chinstrap, closure types) are stated to "add to the effectiveness and safety." |
| Customer Satisfaction: Acceptable comfort, stability, and convenience compared to other market headgear. | "customer satisfaction regarding comfort, stability, and convenience when compared to other headgear on the market" was determined. (Specific results are referenced as being in "Appendix A" but not provided in the excerpt.) |
| Substantial Equivalence Conclusion: Overall, the device is substantially equivalent to predicate devices. | "The results of the performance data show SLUMBERGEAR™ headgear is substantially equivalent to the predicate devices and other headgear previously cleared for market." "SLUMBERGEAR™ headgear is substantially equivalent to the headgear included with REMstar Pro with C-Flex CPAP System K021861 and the headgear included with Mirage Vista™ Mask K031047." |
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 mentions that "SLUMBERGEAR™ headgear was tested to determine customer satisfaction." However, no specific sample size for this test is provided within the excerpt. The provenance of the data (e.g., country of origin, retrospective or prospective nature) is also not specified.
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)
Not applicable in this context. The "performance data" described for this device is focused on "customer satisfaction regarding comfort, stability, and convenience." This type of assessment typically involves user feedback, not expert-adjudicated ground truth in a clinical diagnostic sense. Therefore, there were no "experts" establishing a clinical ground truth for a test set in the manner of medical image analysis or similar diagnostic devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As the "performance data" revolves around customer satisfaction/user feedback, there is no mention or implication of a formal adjudication method by experts for a test set. The direct user experience forms the basis of the "results."
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
No. This is a hardware accessory (headgear) and not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a hardware accessory and not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on user feedback and reported customer satisfaction regarding comfort, stability, and convenience. The document states, "SLUMBERGEAR™ was found to be safe and effective," implying an overall positive assessment from this user testing. There is no mention of clinical outcomes data, pathology, or expert consensus serving as a ground truth for a specific medical condition's diagnosis or prognosis for this device.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model, so there is no concept of a "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML model or training set, this question is not relevant.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).