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Intended to perform spirometry in hospital and clinical environments, for adult patients and pediative patients aged 6 years and above.

The SPIROLYSER® Q13 is an electronic spirometer operating on a PC, for the exploration of respiratory function. The spirometer is composed of a single-use sensor that propels the air (FLEISCH principle) and obtains a difference in pressure. Definition of Fleisch type pneumotachograph: A pneumotachograph that measures flow in terms of the proportional pressure drop across a resistance consisting of numerous capillary tubes in parallel. The SPIROWIN® EXPERT software acquires samples sent by the spirometer and determines a flow and a volume so as to display the curves and deduce results. The SPIROLYSER® 013 spirometer is a portable device. In normal use, the patient holds it by the handle, placing the single-use sensor in the mouth. The SPIROLYSER® Q13 is directly powered by the computer USB port via its USB lead. The SPIROWIN® EXPERT software (on the attached PC) calculates, displays and stores data to help the practitioner in the exploration of a patient's respiratory function.

Here's a breakdown of the acceptance criteria and study information for the Q13 SPIROLYSER® based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance Study for Q13 SPIROLYSER®

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Q13 SPIROLYSER® are largely aligned with the performance characteristics of its predicate device, the SPIROLYSER SPL-50 (K010761), and additionally demonstrate compliance with the ATS 2005 Spirometry Testing Recommendations.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Technical Specifications: The primary ground truth for accuracy, range, and resolution was based on the design specifications derived to meet or exceed those of the predicate device.
  • ATS 2005 Spirometry Testing Recommendations: This serves as a widely accepted industry standard for spirometry device performance, and the device was tested against its requirements for flow/volume and pulmonary waveform generation.
  • Flow/volume Pulmonary Waveform Generator: This physical instrument provided the controlled and known inputs against which the device's measurements were compared.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not mention a "training set" in the context of machine learning or AI. The Q13 SPIROLYSER® is a traditional spirometer and does not appear to utilize machine learning for its core measurement functions, and therefore, a training set for an algorithm is not applicable.

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

• Ground Truth for Training Set Establishment: Not applicable, as no training set for a machine learning algorithm was used or described.

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The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.

The TABATABA is a battery operated hand held carbon monoxide monitor for use as an aid in smoking cessation programs. The TABATABA is a complete tool for the prevention of the risks of active or passive smoking. It can be carried in the pocket or on the belt. The device is parametered by an internal menu (time, date, alarm threshold, measurement time of monitoring). It can be connected to a computer via an RS232 port, to record and analyze results.

The provided text describes the TABATABA® CO TESTER, a Carbon Monoxide gas analyzer, and its substantial equivalence to a predicate device (K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd.). The information primarily focuses on a comparison of characteristics rather than a detailed study with specific acceptance criteria and performance metrics typically found for AI/ML devices.

Based on the provided text, a direct table of "acceptance criteria" and "reported device performance" in the context of an AI/ML study is not available. The document is a 510(k) summary for a medical device, which typically establishes substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety/effectiveness data.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML studies. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly demonstrated through bench, standards, and clinical testing showing it's "as safe and effective" as the predicate.

The table below reflects the comparison of characteristics, which served as the basis for the substantial equivalence claim. The "Acceptance Criteria" here are the characteristics of the predicate device that the TABATABA® CO TESTER needed to meet or be comparable to. The "Reported Device Performance" refers to the TABATABA® CO TESTER's characteristics.

Study Proving Device Meets Acceptance Criteria:

The document states that "The results of bench, standards, and clinical testing indicates that the new device is as safe and effective as the predicate devices," and thus supports the conclusion of substantial equivalence. However, the details of these tests are not provided in this summary.

Regarding AI/ML specific questions (which are not directly applicable to this device based on the provided information):

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device. The document mentions "clinical testing data" without specifying sample size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device. The device is a direct measurement tool.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a CO analyzer, the "ground truth" would typically be established by highly accurate laboratory-grade CO measurement instruments. The document doesn't specify the method, but mentions "bench, standards, and clinical testing."
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

In summary: The K080278 submission is for a traditional medical device (CO analyzer) and demonstrates substantial equivalence to a predicate device. It does not involve AI/ML technology, and therefore, many of the questions related to AI/ML study design are not applicable to the information provided. The "acceptance criteria" were the characteristics and performance of the predicate device, which the new device aimed to match or improve upon while remaining substantially equivalent. The study mentioned ("bench, standards, and clinical testing") served to demonstrate this equivalence, although specific data from these studies are not detailed in this summary.

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Intended to perform spirometry and may be used in hospitals and medical offices or at other locations including homes. The accessory is a Bacterial/Viral Filter designed for single patient use. For use on both adult and pediatric patients.

The Ergofilter™ SP1 filter is a bacterial and viral filter with an anatomical mouthpiece, for spirometers. The filter is a single use, non-sterile filter. A new filter must be used for each new patient and for each new spirometry examination. Operating principle of Filtrete™ 3M™ filtration medium: The filtering medium is manufactured by the 3M company in a clean room; it uses an electrostatic process which attracts small mass particles, while having a very small resistance to arr flow; the density and thickness of the filtration medium itself provides an increased filtration capacity.

The provided text describes the Ergofilter™ SP1, a bacterial/viral filter accessory for spirometers, and its comparison to a predicate device. Below is an analysis of its acceptance criteria and the study used to demonstrate its performance, based only on the provided text.

Based on the provided document, the device did not undergo a standalone, human-in-the-loop, or MRMC study. The comparison is primarily based on bench testing of the filter's physical and performance characteristics against a predicate device. No clinical study details (sample size, ground truth, expert qualifications) are provided.

1. Acceptance Criteria and Reported Device Performance

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

The document indicates "bench" and "filter effectiveness" testing, but no specific sample sizes for these tests are provided. No details on data provenance (e.g., country of origin, retrospective/prospective) are given for these tests. The document also mentions "clinical testing data," but no specifics about this data are available within the provided text.

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

No information is provided regarding the number or qualifications of experts used to establish ground truth for any tests.

4. Adjudication method for the test set

No adjudication method is described. The assessment appears to be based on direct measurement of physical properties and performance characteristics.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No, there is no indication that an MRMC comparative effectiveness study was done. The comparison is between the new device and a predicate device based on technical specifications and performance metrics, not human reader performance.

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

The device is a physical filter, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance metrics reported (airflow resistance, bacterial removal efficiency, dead volume) represent the standalone performance of the physical filter itself.

7. The type of ground truth used

The ground truth for the performance metrics (airflow resistance, bacterial removal efficiency, dead volume) would be the measured physical properties and filtration capabilities under controlled laboratory conditions, likely following standardized test methodologies, though these specific methodologies are not detailed in the provided text.

8. The sample size for the training set

The concept of a "training set" is not applicable as this is a physical medical device (filter), not a machine learning algorithm.

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

Not applicable (see point 8).

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