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Linshom Continuous Predictive Respiratory Monitor System (CPRMS) 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.

The CPRMS 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.

CPRMS measurements are used as an adjunct to other clinical information sources.

The Linshom CPRMS (Continuous Predictive Respiratory Monitoring System) is portable, reliable and an inexpensive system for precise detection of spontaneous respiration. It is non-invasive and is not corrupted by motion artifacts. The system autonomously adapts to the local thermal environment to deliver a usable signal without complicated hardware and firmware processing.

The provided text details the FDA 510(k) clearance for the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS), demonstrating its substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, reported device performance metrics in a table, or details regarding the study designs (sample sizes, data provenance, expert qualifications, ground truth establishment, or clinical study effect sizes) that directly prove the device meets pre-defined quantitative acceptance criteria.

The document primarily focuses on:

• Regulatory Clearance: The FDA's determination of substantial equivalence for the CPRMS to its predicate device (Linshom Respiratory Monitoring Device - LRMD).
• Technological Comparison: A table comparing the characteristics of the subject device (CPRMS) and the predicate device (LRMD), highlighting their similarities.
• Non-Clinical Testing Summary: A general statement about the types of non-clinical tests performed (e.g., Lifetime Test, Movement Test, Respiration Rate Test, Tidal Volume Trend Test) and conformance to various medical device standards. It mentions "Statistical analysis, including correlation methods, showed strong alignment with reference data, indicating that the device functions accurately and reliably within its intended use parameters," but does not provide the specific numerical results of these analyses or the acceptance thresholds.

Therefore, based solely on the provided text, I cannot complete many of the requested sections.

Here's a breakdown of what can be inferred from the text and what cannot:

1. A table of acceptance criteria and the reported device performance

The document mentions specific accuracy for respiration rate and tidal volume trend for both the subject and predicate devices:

Note: These are presented as specifications that are "Same" for both devices, implying the CPRMS met these already established performance levels of the predicate device. The text does not explicitly state them as "acceptance criteria" for a new study, but rather as inherent accuracy specifications of the device's mechanism.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document states "The subject device [K240271] underwent testing across the full range of physiological parameters, including respiratory rates from 0-60 breaths per minute (BPM)." This implies a test set was used, but its size or specific characteristics (e.g., number of subjects, number of data points) are not provided.
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data. The testing mentioned appears to be laboratory/non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. The document outlines non-clinical testing focused on device performance against reference data, not human expert interpretation of clinical data for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/Not specified for this type of non-clinical device performance testing. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading).

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 MRMC or human-in-the-loop study is mentioned. The device provides measurements (respiratory rate, seconds since last breath, tidal volume trend) as an adjunct to other clinical information sources, but the text does not describe a study where human readers/clinicians used the device and their performance was evaluated comparatively.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, implicitly. The "Non-Clinical and/or Clinical Tests Summary" describes tests where the device's measurements (respiration rate, tidal volume trend) were compared against "reference data," indicating a standalone evaluation of the algorithm's performance against a known standard.

7. The type of ground truth used

• Reference Data: The document states "Statistical analysis, including correlation methods, showed strong alignment with reference data." This implies that the ground truth was derived from established, accurate measurement methods or simulated physiological parameters (e.g., a ventilator for tidal volume, a controlled breathing simulator for respiration rate). It's not explicitly stated as expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not specified. The document mentions "Proprietary Algorithm" for both subject and predicate devices but provides no details on how these algorithms were developed or trained, nor the size of any training datasets.

9. How the ground truth for the training set was established

• Not specified. As no training set details are provided, the method for establishing its ground truth is also absent.

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