Search Results

The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a singlepatient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.

Spirotel is a pocket spirometer that can also feature a pulse oximeter function (optional). It measures a range of functional respiratory parameters, and the oxygen saturation and pulse rate. The device can operate completely autonomously or can be connected to a personal computer by means of various types of connections: USB, Bluetooth, GSM.

Here's a breakdown of the acceptance criteria and the study information for the Spirotel device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes used for the spirometry or oximetry accuracy tests, nor for the safety and environmental testing, or data transmission tests. It states that "Testing was done" and "The results obtained were within the range of accuracy required."
• Data Provenance:
  • Spirometry: The spirometry testing was performed "according with American Thoracic Society (ATS) Standards." This suggests an in-house evaluation against established clinical standards.
  • Oximetry: The oximetry accuracy was "verified in-house using an optical simulator." This indicates an in-house, lab-based study.
  • Safety and Environmental: Testing was conducted in accordance with EN 60601-1:2006 and EN 60601-1-2:2007, implying adherence to international standards.
  • Battery, USB, Bluetooth, GSM: These were "carried out in-house" or by "a third party laboratory" (for Bluetooth FCC certification) or "by the manufacturer of the module" (for GSM integration). The data is retrospective, as the tests were completed before submission.
  • Country of Origin: The submitter is MIR Medical International Research, located in Rome, Italy. The testing was largely "in-house," implying it was conducted by MIR.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• The document does not specify the number of experts or their qualifications used to establish the ground truth for the device's performance tests.
• For spirometry, the implicitly accepted ground truth is the performance criteria set by American Thoracic Society (ATS) Standards.
• For oximetry, the implicitly accepted ground truth is the performance criteria set by FDA guidelines on Pulse Oximeters and ISO 9919:2005, realized via an "optical simulator."

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set results. The evaluations seem to be direct comparisons against established technical and clinical standards.

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

• No MRMC comparative effectiveness study is mentioned. The submission focuses on device performance against technical standards and equivalence to a predicate device, not on human reader performance with or without AI assistance.

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

• The device itself (Spirotel) is a measurement device that provides physiological data (spirometry and oximetry parameters). The testing described focuses on the accuracy and reliability of these measurements in a standalone fashion, adhering to technical and clinical standards. There is no "algorithm only" performance separate from the device's inherent function, as it is not an AI-driven interpretive system in the sense of image analysis, for example. The various communication modules (USB, Bluetooth, GSM) facilitate data transmission, and their standalone performance for data integrity was tested.

7. Type of Ground Truth Used

• Spirometry: Ground truth is implicitly defined by American Thoracic Society (ATS) Standards for volume and flow rate accuracy.
• Oximetry: Ground truth is implicitly defined by FDA guideline on Pulse Oximeters and ISO 9919:2005, implemented and verified using an optical simulator.
• Safety & Environmental: Ground truth is based on compliance with international standards EN 60601-1:2006 and EN 60601-1-2:2007.
• Data Transmission: Ground truth is the integrity of data transmission (i.e., no corruption), verified by in-house testing.

8. Sample Size for the Training Set

• The document does not refer to any "training set." The Spirotel device is a measurement instrument, not a machine learning or AI algorithm that requires a training set in the typical sense. Its performance is validated against established physical and clinical standards rather than through learning from data.

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

• As there is no mention of a "training set" for the device's core functionality, this question is not applicable to the information provided.

Ask a specific question about this device

The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.

MIR Spirotel is a simple to operate precise pocket spirometer and pulse oximeter (weight only 100g). It measures the most important functional respiratory parameters and monitors the oxygen saturation and pulse rate.

The provided document is a 510(k) summary for the MIR Spirotel device, which combines a spirometer and a pulse oximeter. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain detailed acceptance criteria or a multi-reader multi-case (MRMC) comparative effectiveness study.

However, it does mention standalone performance testing. Here's what can be extracted and inferred based on the provided text:

Acceptance Criteria and Reported Device Performance

The document generally states compliance with standards rather than specific numerical acceptance criteria.

Study Details

The document describes performance testing for both spirometry and pulse oximetry.

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

• Test Set Sample Size: Not specified for either spirometry or pulse oximetry. The document only mentions "clinical testing."
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

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

• Not specified. The document only states that spirometry testing was against "American Thoracic Society (ATS) Standards" and oximetry results were "within specification," implying comparison to a reference standard, but it doesn't detail human expert involvement in establishing ground truth for the test data itself.

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

• Not applicable/Not specified. The testing described focuses on device performance against established standards rather than diagnostic agreement adjudicated by multiple experts.

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

• No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a measurement tool (spirometer and pulse oximeter), not an AI-based diagnostic interpretation tool.
• Effect size improvement without AI: Not applicable, as no MRMC study was conducted, and the device itself is a measurement tool, not an AI for human reader assistance.

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

• Yes. The described clinical testing for both spirometry and pulse oximetry appears to be standalone performance testing of the device itself against established standards or specifications. The document states:
  • "Testing of device performance included clinical testing of both spirometry and pulse oximetry functions."
  • "Spirometry testing was performed according with American Thorotic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS."
  • "For oximetry testing a desaturation trial was conducted. The results obtained were within specification."

6. The type of ground truth used:

• Spirometry: Inferred to be a reference standard compliant with "American Thoracic Society (ATS) Standards." This typically involves a highly accurate and calibrated spirometer as a reference.
• Pulse Oximetry: Inferred to be a reference standard for oxygen saturation measurement during a "desaturation trial." This usually involves co-oximetry (blood gas analysis) for accurate SpO2 reference values.

7. The sample size for the training set:

• Not applicable/Not specified. The Spirotel described here is a hardware device for measurement, not an AI/machine learning algorithm that requires a training set in the conventional sense.

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

• Not applicable. (See point 7).

Ask a specific question about this device

The spirotel spirometer is intended to be used by a patient under indications For 500. The opirator epiratory therapist to test lung function in people of all the matraction of a priyation of a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for the Spirotel, Model 29-1020, does not contain the detailed information necessary to answer the questions about acceptance criteria and the specific study proving the device meets those criteria.

The document primarily focuses on the FDA's substantial equivalence determination, the regulatory classification of the device, and general compliance requirements. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes (test set, training set), data provenance.
• Information on experts used for ground truth, adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
• The type of ground truth used or how it was established for training or testing.

Therefore, I cannot generate the requested table and answer the specific study-related questions based on the input provided.

Ask a specific question about this device