Search Results

The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.

The provided text is a 510(k) summary for the STS device, a pulmonary function data calculator. While it mentions a clinical study, the details provided are limited and do not fully address all requested points regarding acceptance criteria and study specifics for proving the device meets those criteria.

Based on the provided document, here's what can be extracted and what remains unknown:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria values for performance. However, an implicit acceptance criterion is a "high correlation" and specific statistical thresholds mentioned in the clinical study summary.

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

• Sample Size: 161 subjects (61 females, 100 males, implicitly). This test set was used for the clinical study comparing STS to Body Plethysmography.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as subjects were "enrolled" and "tested by both STS and BP," suggesting data was collected specifically for this study.

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

• The document states that Body Plethysmography (BP) is considered the "gold standard" for measuring lung volumes. Therefore, the BP measurements served as the ground truth.
• It does not specify the number of experts or their qualifications involved in performing or interpreting the Body Plethysmography tests. It's implied that standard clinical practice for BP was followed, which would involve trained medical professionals, but this is not detailed.

4. Adjudication method for the test set:

• No information on adjudication methods is provided. The comparison is directly between the STS device measurements and the "gold standard" Body Plethysmography measurements.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported. This device is a pulmonary function data calculator and not an AI-assisted diagnostic imaging tool where human reader performance with and without AI assistance would typically be evaluated. The study focuses on the device's accuracy in measuring physiological parameters when compared to a gold standard.

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

• The clinical study described evaluates the "performance of STS technique in calculating resistance and compliance parameters" by comparing it with Body Plethysmography.
• The STS device itself is a "pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters." This implies a standalone performance evaluation of the device's measurements against the gold standard. However, the device "is to be used by either a physician, respiratory therapist, or technician" and its results are "displayed on the physician's computer via the STS software/App," indicating there's a human-in-the-loop for operation and interpretation. The study evaluates the measurement accuracy, which can be seen as a form of standalone performance for the measurement part of the device.

7. The type of ground truth used:

• The ground truth used was "gold standard" Body Plethysmography (BP) measurements of lung volumes. While BP is a clinical measurement, it serves as the established reference standard in this context.

8. The sample size for the training set:

• The document does not provide any information about the sample size used for the training set. This is a 510(k) submission, and often, proprietary training data details are not included in the public summary.

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

• The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.

Ask a specific question about this device