(129 days)
AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home settings use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
AcuPebble Ox100 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox100 comprises: 1- A small physiological sensing device, identical to the previously cleared device AcuPebble SA100 (K210480) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" too); 2- Another physiological wireless sensing device ("AcuPebble finger oximetry sensor") worn on the finger; 3- A mobile device app (the "AcuPebble Ox100 app") that guides the patient through the steps of the test, collects the data from the sensor (continuously in the case of the "AcuPebble SA100 sensor", and at the end of the test in the case of the "AcuPebble finger oximetry sensor"), and uploads them in the cloud ; 4- A cloud-based software that analyses the signals from the "AcuPebble SA100 sensor" (already cleared as part of K210480); 5- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters. Outputs of the device relevant to its intended use are further described in the comparison table below.
The provided text describes the AcuPebble Ox100 device and its substantial equivalence to a predicate device (AcuPebble SA100, K210480) based on various performance data and testing. However, it does not contain a detailed study specifically proving that the device meets defined acceptance criteria for its effectiveness in aiding the evaluation of Obstructive Sleep Apnea (OSA).
The information provided primarily focuses on:
- Comparison to Predicate and Reference Devices: Highlighting similarities in indications for use, regulation, target population, environment of use, and certain performance metrics previously claimed for the predicate or a reference device (NightOwl, K191031).
- Compliance with Recognized Consensus Standards: For biocompatibility, electrical safety (EMC), home healthcare safety, risk management, and software development.
- High-level performance metrics: AHI, ODI, Diagnostic LR+, LR-, Sensitivity, Specificity, and Pulse rate/SpO2 performance, which appear to be inherited or similar to the predicate/reference device claims rather than outcomes of a new primary study for AcuPebble Ox100's specific combination of sensors.
Information NOT explicitly available in the provided text:
- A dedicated table of acceptance criteria for AcuPebble Ox100 with its own reported performance to demonstrate compliance.
- Detailed information about a specific clinical study conducted for AcuPebble Ox100 to prove its diagnostic performance. The diagnostic metrics listed (Sensitivity, Specificity, etc.) are presented as "Same" compared to the predicate, implying these are existing claims rather than results from a new study specific to Ox100 to justify a de novo clearance.
- Sample sizes for a test set specifically for demonstrating the performance of AcuPebble Ox100 in diagnosing OSA.
- Data provenance (country of origin, retrospective/prospective) for a study validating AcuPebble Ox100's diagnostic capabilities.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth of a test set for AcuPebble Ox100's diagnostic performance.
- Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done for AcuPebble Ox100, or any effect size of AI assistance.
- The type of ground truth used for a study validating AcuPebble Ox100's diagnostic capabilities.
- Sample size and ground truth establishment for the training set of AcuPebble Ox100's diagnostic algorithm.
Based on the provided text, here's what can be extracted, and what is missing or implied:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a standalone table of "acceptance criteria" for the AcuPebble Ox100 followed by "reported device performance" from a new study of this specific device. Instead, it compares the AcuPebble Ox100's characteristics and performance to its predicate (AcuPebble SA100) and a reference device (NightOwl) in a tabular format. The performance metrics listed are presented as "Same" to the predicate, implying that these are the established performance levels from the predicate device that the AcuPebble Ox100 is deemed to meet by being substantially equivalent.
Here's a reconstruction of the relevant performance metrics mentioned, noting that these are largely presented as being "Same" as the predicate:
| Performance Metric | Acceptance Criteria (Implied / From Predicate) | Reported Device Performance (Likely Inherited from Predicate) |
|---|---|---|
| Diagnostic LR+ | Not explicitly stated as acceptance criteria, but listed as 29.36 /32.29 for predicate | 29.36 /32.29 (Stated as "Same") |
| Diagnostic LR- | Not explicitly stated as acceptance criteria, but listed as 0.08 /0.04 for predicate | 0.08 /0.04 (CI- 0.03 to 0.19/0.01 to 0.16) (Stated as "Same") |
| Diagnostic Sensitivity | Not explicitly stated as acceptance criteria, but listed as 92.73% /95.92% for predicate | 92.73% /95.92% (CI-82.41% to 97.98% /86.02% to 99.50%) (Stated as "Same") |
| Diagnostic Specificity | Not explicitly stated as acceptance criteria, but listed as 96.84% /97.03% for predicate | 96.84% /97.03% (Stated as "Same") |
| Pulse rate (from heart sounds) | Not explicitly stated as acceptance criteria, but listed as 50-120bpm for predicate | 50-120bpm (3.62bpm validation accuracy) (Stated as "Same") |
| Pulse rate (from PPG) | ±2bpm or ±2% | Meets requirement of ±2bpm or ±2%. |
| SpO2 performance (80%-100% range) | Compliant with ISO 80601-2-61 (2% root-mean-square difference) | 2% root-mean-square difference |
| SpO2 performance (70%-79% range) | Compliant with ISO 80601-2-61 (3% root-mean-square difference) | 3% root-mean-square difference |
| SpO2 performance (70-100% SaO2) | Compliant with ISO 80601-2-61 (≤4% root-mean-square difference) (from reference device) | (Implied to meet this based on specific ranges above) |
| Biocompatibility | ISO 10993 requirements (sensitization, irritation, cytotoxicity, USP class VI) | Complies (passing results for finger sensor, neck sensor same as cleared predicate) |
| General Safety and EMC | IEC 60601-1:2005:MOD, IEC 60601-1-2:2014 | Complies |
| Home Healthcare Environment Safety | IEC 60601-1-11:2015 | Complies |
| Risk Management | ISO 14971:2019 | Complies |
| Software Verification and Validation | IEC 62304:2006/A1:2016, FDA Cybersecurity Guidance | Complies (software level of concern: "moderate") |
2. Sample size used for the test set and the data provenance:
- Not specified for a new effectiveness study of AcuPebble Ox100. The performance metrics (Diagnostic LR+, LR-, Sensitivity, Specificity) are stated to be the "Same" as the predicate device (AcuPebble SA100). Therefore, any sample size and data provenance would refer to the previous clearance of K210480. This information is not provided in the document for K210480.
- For the SpO2 performance, compliance with ISO 80601-2-61 is stated. Such compliance typically requires specific testing against a reference oximeter in a clinical setting with a certain number of subjects across defined SpO2 ranges, but the specific sample size, country of origin, or retrospective/prospective nature of this verification for AcuPebble Ox100 is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified for a new effectiveness study of AcuPebble Ox100. This information would be relevant for the diagnostic performance metrics, which are stated to be "Same" as the predicate. Details for the predicate (K210480) are not in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified for a new effectiveness study of AcuPebble Ox100. This would relate to the diagnostic performance metrics, which are stated to be "Same" as the predicate. Details for the predicate (K210480) are not in this document.
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 such study is mentioned or described for AcuPebble Ox100. The device is intended to aid in evaluation, but no comparative effectiveness study with human readers (with vs. without AI assistance) is detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The diagnostic performance metrics listed (Sensitivity, Specificity, LR+, LR-) usually reflect standalone algorithm performance against a gold standard. However, these are listed as "Same" to the predicate device (AcuPebble SA100). The document does not provide details of a new standalone study for AcuPebble Ox100 itself to derive these numbers. The "cloud-based software that analyses the signals" and "web app user interface for healthcare professionals" suggest an algorithmic analysis component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified for a new effectiveness study of AcuPebble Ox100. For diagnostic assessments of OSA, polysomnography (PSG) scored by experts according to AASM guidelines is the typical gold standard/ground truth. However, the document does not confirm this for a specific study validating AcuPebble Ox100's performance.
8. The sample size for the training set:
- Not specified. The document refers to "A cloud-based software that analyses the signals" but does not provide details on its training set or how it was developed for AcuPebble Ox100.
9. How the ground truth for the training set was established:
- Not specified.
§ 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).