(90 days)
The SleepStrip II is intended to measure apnea/hyponea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings.
The SleepStrip II is formed like a soft plastic "strip" or patch which is adhesively applied on the face under the nose for one night sleep. The SleepStrip II device comprises the following four main components: 1. Flexible body. 2. Sensor and signal acquisition and analysis hardware and firmware. 3. Battery as a power source. 4. A result display element. The SleepStrip II is designed to show a Sleep Apnea Syndrome (SAS) study results. It includes sensors, hardware and software to facilitate a sleep apnea screening study at the patient's home over one night sleep (under prescription). The SleepStrip II, detects and counts respiratory events (apneas and hypopneas) in real time.
The provided text does not contain detailed information about specific acceptance criteria for performance metrics or a comprehensive study demonstrating that the SleepStrip II meets these criteria. The document focuses on demonstrating substantial equivalence to a predicate device through a series of performance tests, rather than defining and proving specific quantitative acceptance criteria for a new device.
Here's a breakdown of what is available and what is missing:
The document states that the SleepStrip II is substantially equivalent to the cleared SleepStrip (K002135). The assessment of substantial equivalence relies on various performance tests and comparisons to the predicate device rather than defining new, specific acceptance thresholds for the SleepStrip II.
Missing Information:
- Specific Acceptance Criteria Table: The document does not provide a table of acceptance criteria with quantitative thresholds (e.g., specific accuracy, sensitivity, or specificity targets) and the reported device performance against those criteria.
- Sample Size for Test Set and Data Provenance: While performance testing is mentioned, the text does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective/prospective).
- Number and Qualifications of Experts for Ground Truth: There is no mention of experts being used to establish a ground truth for a test set, nor their number or qualifications.
- Adjudication Method: No adjudication method (e.g., 2+1, 3+1, none) is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was conducted, nor any mention of human reader improvement with or without AI assistance.
- Standalone Performance Study: While "Software verification and validation" and "Bench tests /Performance testing" are mentioned, the document does not describe a formal standalone performance study with specific results. The focus is on verifying individual components and overall functionality.
- Type of Ground Truth Used: The nature of the ground truth (e.g., expert consensus, pathology, outcomes data) for any performance evaluation is not specified.
- Sample Size for Training Set: Since the device is not described as involving a learning algorithm that would require a "training set" in the typical machine learning sense, this information is not applicable and not provided. The development process seems more aligned with traditional embedded systems and signal processing.
- Ground Truth Establishment for Training Set: As above, this is not applicable given the apparent nature of the device's technology.
What is Reported Regarding Performance and Testing:
The document (Section 7.1.12 Performance Data & Substantial Equivalence in {1}) states:
- Objective: To demonstrate that the modified SleepStrip II "does not raise any new questions of safety and efficacy" compared to its predicate device, SleepStrip (K002135).
- Approach to Substantial Equivalence: The SleepStrip II is considered "substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc." to the predicate device.
- Performance Testing Categories: A series of performance tests were conducted, including:
- Software verification and validation
- Bench tests /Performance testing: Pressure Channel signal validity
- Bench tests /Performance testing: Thermal Channel signal validity
- Bench tests /Performance testing: Final Scoring Validity
- Laboratory safety and EMC testing
These tests are described as having been performed to ensure the modified device's safety and efficacy are comparable to the predicate device. However, specific results or quantitative acceptance criteria for these tests are not disclosed in the provided text.
In summary, the provided information outlines the types of tests conducted to support substantial equivalence but lacks the detailed quantitative performance criteria and study results commonly found when a device's performance against specific acceptance criteria is being proven. The regulatory submission focuses on the argument of substantial equivalence to an already cleared device, rather than a de novo demonstration of performance against predefined thresholds.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).