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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

Study Information

The document describes performance data that includes both bench and clinical testing.

1. 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).

2. 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.

3. 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.

4. 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).

5. 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.

6. 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).

7. 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.

8. How the ground truth for the training set was established:

   • Not provided, as information about a training set is absent from the document.

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Steerable stainless steel core with radiopaque marker; a jacket, and polymer/hydrophilic coating is applied over the core/coil. The quidewires are bound by the following parameters: Outside Diameter: .016" - .045" Lengths: 20 cm -- 400 cm Tips: Straight, Shapable with standard and stiff tip flexibility

Device Acceptance Criteria and Study Details:

This document describes the acceptance criteria and the study performed for a guidewire produced by Lake Region Manufacturing, Inc. (LRM). The study aims to demonstrate substantial equivalence of guidewires manufactured with a polymer/hydrophilic coating to existing predicate guidewires, specifically Terumo guidewires.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All test results were within prescribed specification limits." While specific numerical acceptance criteria ranges are not provided, the reported performance indicates successful adherence to predefined standards for each test. For the biocompatibility tests, the results explicitly state whether the material passed or met the expectations for safety.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Sizes:
  • For each of the three product groups (.018" standard, .035" standard, and .038" stiff configurations), at least 200 samples were produced (600+ total samples).
  • For each individual test, either 20 or 30 samples were selected.
  • Additional sets of 20 or 30 samples were used for destructive tests.
• Data Provenance: The data is prospective, as LRM manufactured "production samples" and "LRM samples" specifically for this comparative testing. The predicate Terumo product was "purchased by LRM, complete in packaging" for direct comparison. The country of origin for the data is implicitly the United States, as LRM is a U.S. company and the submission is to the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• The document does not specify the number of experts or their qualifications used to establish ground truth for the functional performance tests (Lubricity, Rotational Control, etc.). These tests appear to be objective, quantitative measurements against predefined engineering specifications.
• For biocompatibility tests, these are typically performed in specialized laboratories following established protocols, implying certified personnel, but specific expert qualifications are not detailed.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for the test set results. The tests appear to be objective measurements compared against internal specifications or the performance of the predicate device. Therefore, it is likely that no formal adjudication was required beyond comparing the results to the established criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices where human interpretation is involved. For a guidewire, the effectiveness is assessed through its physical and performance characteristics, not through human reader interpretation of output.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the studies performed were standalone in the sense that they evaluated the device's inherent physical and functional properties directly. There is no "algorithm" or human-in-the-loop component to a guidewire's fundamental performance assessment in this context. The tests measure the device's characteristics directly.

7. Type of Ground Truth Used:

• The ground truth used for the functional performance tests (Lubricity, Dimensional Measurement, etc.) is defined engineering specifications and comparative performance against a predicate device (Terumo guidewires). The goal was to show that the LRM device met its own specifications and was equivalent to the predicate.
• For the biocompatibility tests, the ground truth is established by validated laboratory protocols and reference standards, following recommendations from the FDA's "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices."

8. Sample Size for the Training Set:

• The concept of a "training set" is not applicable to this submission. The device is a physical medical instrument, not a machine learning algorithm. The manufacturing process itself could be considered "trained" through years of experience and quality controls, but there isn't a distinct "training set" of data in the AI/ML sense.

9. How the Ground Truth for the Training Set Was Established:

• As the concept of a training set is not applicable, this question is not relevant to this device submission. The "ground truth" for the manufacturing process is established through documented quality systems, engineering change order reviews, material qualification, product qualification, and process qualification. These controls ensure consistency and adherence to design specifications over time.

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The "Intended Use" of the polymer/hydrophilic coated guidewire is to facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures.

LRM produces quidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission. These devices are commonly known as quides, quidewires, or spring quidewires.

This document is a 510(k) premarket notification for a guidewire. It describes the device, its intended use, and its classification. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, or any of the other study-related details requested in your prompt.

Therefore, I cannot provide the requested table or answer the specific questions about the device's performance study based on the provided text. The document focuses solely on the regulatory classification and identification of the device itself, not on data demonstrating its efficacy or safety.

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