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The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.

It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.

The Respirometer is a mechanically driven dial, where the dial indicates gas volume passed, and the mechanism is driven by the kinetic energy in the flowing gas. The device measures expirate gas flow and measurements are unaffected by inspirate gas flow. It has an on/off button to lock the pointer and a reset button to return the pointer to zero when it approaches full scale

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wright/Haloscale Respirometer:

This document is a 510(k) summary for a medical device that measures lung ventilation, and as such, it focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a novel clinical study to establish new acceptance criteria and prove its performance.

Therefore, many of the typical acceptance criteria and study elements you requested (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance with ground truth, etc.) are not applicable or not explicitly detailed in this type of submission. The "study" here is primarily a bench-testing and technical comparison to the predicate device and established technical standards.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

   The "acceptance criteria" for a 510(k) are typically derived from the performance specifications of the predicate device and relevant industry standards. The device's reported performance is then compared to these.

   Acceptance Criteria (from Predicate/Standards)	Reported Device Performance (Wright/Haloscale Respirometer)
   Accuracy
   Tidal Volumes: ± 3% for minute volumes > 5 LPM	Achieved: ± 3% for minute volumes exceeding 5 LPM
   Continuous Flow: ± 4% for minute volumes > 4 LPM	Achieved: ± 4% for minute volumes exceeding 4 LPM
   Continuous Flow: ± 2% @ 16 LPM	Achieved: ± 2% @ 16 LPM
   Continuous Flow: ± 5% to + 10% @ 60 LPM	Achieved: ± 5% to + 10% @ 60 LPM
   Sensitivity
   Starts volume registration at not more than 2.5 LPM	Achieved: Starts volume registration at not more than 2.5 LPM
   Resistance
   Proportional to square of flow rate, not more than 2cm H2O @ 100 LPM	Achieved: Proportional to square of the flow rate and not more than 2cm H2O @ 100 LPM
   Dead Space
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 22 ml
   Permissible Gases
   Not specified (implied to be similar to predicate if not mentioned)	Reported: All respirable gases
   Maximum Temperature
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 55°C (131°F)
   Maximum internal to external pressure
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 30cm H2O
   Maximum Leakage
   60ml/min at 30cm H2O (to ASTM F1208-89)	Achieved: 60ml/min at 30cm H2O (to ASTM F1208-89)
   Maximum Recommended Flow Rate
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 60 LPM (300 LPM continuous flow for short periods)

   Note: "Not specified" for criteria where only the device's reported performance is given means the document doesn't explicitly state the predicate's equivalent spec, but the FDA's acceptance implies it met an unstated or inferred standard.

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

   • Sample Size: Not specified. This would typically involve a series of bench tests using controlled gas flow measurements. The number of repetitions or specific test conditions is not detailed in this summary.
   • Data Provenance: The data provenance is laboratory/bench testing conducted by nSpire Health, Inc. This is not clinical data from patients (retrospective or prospective). The location is implied to be at the manufacturer's facility (Longmont, CO).

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

   • Not Applicable. For a device of this type undergoing a 510(k) for substantial equivalence, clinical expert ground truth is typically not required for the technical characteristics comparison. The "ground truth" for the technical specifications is established by calibrated flow meters and pressure sensors used during bench testing.

4. Adjudication method for the test set

   • Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert opinions, typically in clinical studies or evaluations of subjective interpretations (e.g., image analysis). This is a technical performance assessment, not an expert review.

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

   • Not Applicable. This device is a mechanical respirometer, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was done, and there is no AI component.

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

   • Yes, in essence. The performance data presented (accuracy, sensitivity, resistance, etc.) are inherent characteristics of the device itself, determined through direct measurement during laboratory testing. It operates as a standalone mechanical device without human-in-the-loop performance in the sense of interpretative assistance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • The "ground truth" for the technical characteristics is based on calibrated physical measurements from standard laboratory equipment (e.g., reference flow meters, pressure gauges) and adherence to established industry standards like ASTM F1208-89.

8. The sample size for the training set

   • Not Applicable. This is a mechanical device, not a machine learning or AI model, so there is no concept of a "training set."

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

   • Not Applicable. Since there is no training set, this question is not relevant.

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