(167 days)
The WatchPAT™ONE (WP1) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP1 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP1 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP1's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP1's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
The WatchPAT™ONE (WP1) is a non-invasive home care device intended for use with patients suspected to have sleep related breathing disorders. The WP1 generates a PAT respiratory disturbance index (PRDI), Apnea Hypopnea Index (PAHI), Central Apnea Hypopnea Index (PAHIc), sleep stages (PSTAGES - REM Sleep, Light Sleep, Deep Sleep and Wake) and snoring level and body position discrete states. The WP1 device consists of the following: (1) same unified finger PAT probe that was used in WP300 to measure the PAT and oximeter signals; (2) same Actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) same electronics, except for an antenna added in the WP1's PCB to support BLE communication; (4) same chest sensor (RESBP) to measure snoring level, body position and chest movements; and (5) same zzzPAT Software and algorithm to analyze the data. The subject WP1 is a modified version of the predicate WP300 device (K180775). The proposed modifications mainly include: transition from a reusable device to a single use device; shifting the display and user interface from the device to a mobile application; and shifting of the data storage from main device to a web server.
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.
The document is a 510(k) premarket notification summary for the WatchPAT™ONE (WP1) device. It focuses on demonstrating substantial equivalence to a predicate device (Watch-PAT 300, K180775), rather than presenting a standalone clinical validation study with detailed performance metrics against specific acceptance criteria.
However, I can extract information related to performance testing and comparison with the predicate device.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or correlation coefficients) for the WatchPAT™ONE. Instead, it relies on demonstrating that the new device (WP1) has substantially equivalent performance to its predicate device (WP300) through bench testing and compliance with electrical safety, EMC, and software standards.
What is reported (indirectly, by demonstrating equivalence to predicate):
| Performance Aspect | Predicate Device (Watch-PAT 300) Performance (Implied by equivalence) | Subject Device (WatchPAT™ONE) Performance (Implied by equivalence + testing) | Conclusion on Equivalence |
|---|---|---|---|
| Data Acquisition | Data acquired by WP300 via USB | Data acquired by WP1 via BLE, then to web server | Bench test shows data acquired on WP1 is identical to data downloaded by zzzPAT (from WP300 process). |
| Analysis Output (PRDI, PAHI, PAHIC, Sleep stages, Snoring, Body Position) | Same as WP1 | Same as WP300 | Identical algorithms (zzzPAT software) and output parameters. |
| Electrical Safety | Compliant with IEC 60601-1:2005, AM1:2012 | Compliant with IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) and AM1:2012 | Met standards. |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2:2007 | Compliant with IEC 60601-1-2:2014 | Met standards. |
| Home Healthcare Environment | Compliant with 60601-1-11:2015 | Compliant with 60601-1-11:2015 | Met standards. |
| Biocompatibility (New materials) | Existing materials compliant | New housing and wrist strap materials tested for cytotoxicity, irritation, and sensitization. | Passed testing. |
| Software Verification & Validation | Software met design specifications | Software met design specifications | Performed and demonstrated compliance. |
| Measurement Consistency | Consistent with WP300 | Same hardware components (uPAT finger probe, actigraph, controller, microphone, accelerometer, chest sensor) and zzzPAT software/algorithm for analysis. | Bench test confirms data acquired by WP1 is identical. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not specify a sample size for a clinical test set in the traditional sense of a performance study with patients. The "Performance Testing" section mentions "Bench test was conducted to show that the data acquired on the WP1 is identical to the data downloaded by zzzPAT at the physician computer." This implies a comparison focused on the integrity of data transmission and processing rather than a clinical performance evaluation on a patient cohort. No number of patients or recordings is provided for this bench test.
- Data Provenance: Not specified. The document focuses on the mechanical/software changes and equivalence to the predicate, rather than a new clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. The document describes bench testing and adherence to standards, and states that the "zzzPAT Software and algorithm to analyze the data" remains the same as the predicate device. It does not refer to a study where human experts established ground truth for a test set.
4. Adjudication Method:
- Not Applicable. As no expert-derived ground truth for a test set is discussed, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not mention an MRMC study or any study comparing human readers with and without AI assistance. The focus is on device equivalence, not clinical performance enhancement for human readers.
6. Standalone Performance Study:
- No, not explicitly a standalone clinical performance study. The "Performance Testing" section describes bench tests to confirm data acquisition identity and compliance with various standards (electrical safety, EMC, software V&V, biocompatibility). It aims to show the WP1 is substantially equivalent to the predicate device in its fundamental operation and data output, which the predicate device presumably had its own standalone performance demonstrated previously (K180775). The current submission does not include a new standalone clinical study for sensitivity, specificity, etc., for the WP1.
7. Type of Ground Truth Used:
- The document implies that the "ground truth" for its performance testing is the data output from the predicate device (Watch-PAT 300) processed by the zzzPAT software. The bench test establishes that the WP1 acquires data that is "identical" to what the zzzPAT software would process (which is the same software used by the predicate). There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this specific submission's performance evaluation.
8. Sample Size for the Training Set:
- Not Applicable/Not Provided. The document explicitly states that the WP1 uses the "same zzzPAT Software and algorithm to analyze the data" as the predicate device. This suggests that any algorithm training would have been done for the predicate device, not the WP1 itself. The current submission does not describe a training set for the WP1.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable/Not Provided. Since no training set for the WP1 is discussed, the method for establishing its ground truth is also not provided. This information would likely be found in the K180775 filing for the predicate device if it involved algorithmic training.
In summary:
The document describes a 510(k) submission for the WatchPAT™ONE (WP1), demonstrating substantial equivalence to its predicate device (Watch-PAT 300). The "acceptance criteria" are primarily based on:
- Functional equivalence: performing the same functions and producing the same outputs (PRDI, PAHI, etc.) using the same core technology and algorithms (zzzPAT software).
- Data integrity: ensuring the data acquired by WP1 is "identical" to data handled by the predicate's process.
- Compliance with relevant standards: electrical safety, EMC, home healthcare environment, biocompatibility of new materials, and software verification/validation.
It does not detail a clinical study with specific acceptance criteria (e.g., sensitivity/specificity targets) for diagnostic performance using a new patient test set with expert-derived ground truth. The performance testing mentioned is focused on verifying that the modified WP1 functions identically to the predicate device in terms of data acquisition and processing.
§ 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).