(315 days)
Linshom Respiratory Monitoring Device (LRMD) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult (at least 22 years of age) patients.
LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume.
LRMD measurements are used as an adjunct to other clinical information sources.
The Linshom Respiratory Monitoring Device (LRMD) is a medical device designed to monitor a patient's respiratory rate, tidal volume trend and seconds since last breath within a healthcare setting. The LRMD is a thermistor based respiratory monitor which includes the Thermistor Sensor Assembly (TSA), Integrated Linshom Module (ILM) Core, the power supply and software.
Here's a breakdown of the acceptance criteria and study information for the Linshom Respiratory Monitoring Device (LRMD) based on the provided document:
Acceptance Criteria and Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Respiratory Rate | ± 1 BPM | ± 1 BPM |
| Tidal Volume Trend | Not explicitly stated as a numerical criterion in the table, but indicated by comparison with predicate. | 0.97 (r² correlation to ventilator) |
| Working Range (Respiration) | 5-60 BPM | 5-60 BPM |
| Working Range (Tidal Volume) | 120-1000mL | 120-1000mL |
| Ambient Operating Temperature | 65°F - 85°F (18.3°C - 29.4°C) | 65°F - 85°F (18.3°C - 29.4°C) |
Study Information
The document describes performance data that includes both bench and clinical testing.
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Sample sizes used for the test set and the data provenance:
- Respiratory rate:
- 38 volunteer subjects (for respiratory rate)
- 12 endoscopy subjects (for respiratory rate)
- Tidal Volume Trend:
- 40 volunteer subjects (for tidal volume)
- Data Provenance: Not explicitly stated, but the mention of "volunteer subjects" and "endoscopy subjects" suggests prospective data collection within a clinical setting. Country of origin is not specified but is implied to be within the scope of FDA regulations (likely United States).
- Respiratory rate:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The ground truth for respiratory rate was compared to capnography, and for tidal volume trend, it was compared to a ventilator. This implies the use of established medical equipment as the gold standard, rather than expert consensus on observational data.
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Adjudication method for the test set:
- Not explicitly stated. Given the use of objective medical equipment (capnography, ventilator) as the gold standard, a formal expert adjudication method (like 2+1 or 3+1) would likely not be applicable in the same way it is for subjective image interpretation.
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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 MRMC comparative effectiveness study was done, as this device focuses on direct physiological measurement rather than aiding human interpretation of complex data (e.g., medical images).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (accuracy of respiratory rate and tidal volume trend) reflects the standalone performance of the LRMD device. The device is designed to report values and display trends, implying its direct measurement capability. The indication for use notes that "LRMD measurements are used as an adjunct to other clinical information sources," but the reported accuracy metrics are for the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Respiratory Rate: Capnography (considered a gold standard for respiratory rate measurement).
- Tidal Volume Trend: Ventilator (presumably a ventilator with accurate tidal volume measurement capabilities, used as a gold standard).
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The sample size for the training set:
- Not provided. The document focuses on performance testing for regulatory submission, not the development or training of the underlying algorithms.
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How the ground truth for the training set was established:
- Not provided, as information about a training set is absent from the document.
§ 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).