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The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV1 monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. The device is intended for use with paediatric and adult patients in both home and clinical settings.

The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV I monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions.

The provided text describes the 510(k) summary for the Mini-Wright Digital, a Peak Flow/FEV1 Meter. It outlines its indications for use, technological differences from a predicate device, and performance data.

Here's an analysis of the acceptance criteria and study information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in terms of number of patients or individual measurements. Instead, it mentions "Non-clinical performance data has been compiled by testing the Mini-Wright Digital in accordance with the methods described in the American Thoracic Society's document 'Standardization of Spirometery' 1994 update." This implies laboratory or bench testing rather than a clinical study with human subjects.

The data provenance is not explicitly stated as retrospective or prospective human data, given it's non-clinical performance data. It is implied to be laboratory-generated. The applicant is Clement Clarke Int. Ltd from the United Kingdom, so the testing was likely conducted there.

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

This information is not provided in the document. The testing appears to be based on a recognized technical standard (American Thoracic Society's "Standardization of Spirometery" 1994 update), which would define objective performance metrics rather than relying on expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As the testing was non-clinical and based on objective standards, there wouldn't be a need for an adjudication method among experts.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a standalone peak flow/FEV1 meter, not an AI-assisted diagnostic tool for human readers.

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

Yes, this was a standalone performance study in the sense that the device's accuracy and repeatability were tested as a unit. While it's an electronic device, the term "algorithm only" in the context of AI isn't directly applicable here, as it's a measurement device, not an AI diagnostic algorithm. Its performance was evaluated on its own based on established spirometry standards.

7. The Type of Ground Truth Used

The ground truth for the performance reported was based on technical standards and established recommendations for monitoring devices, specifically the "American Thoracic Society's document 'Standardization of Spirometery' 1994 update." This implies a comparison to a gold standard of measurement defined by the ATS guidelines.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is an electronic measurement instrument, not an AI system that undergoes "training" in the typical machine learning sense. Its design and calibration would be based on engineering principles and conformity to standards rather than a training dataset.

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

This information is not applicable/not provided for the reasons stated in point 8.

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The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.

Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.

The OneFlow FVC is a handheld, battery operated, electronic spirometer. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.

The provided document describes the OneFlow FVC, a handheld electronic spirometer. The performance data section refers to adherence to the American Thoracic Society's "Standardization of Spirometery" 1994 update. However, the document does not explicitly define specific numerical acceptance criteria for this device beyond stating that "All tests undertaken where found to be within the stated recommendations for a monitoring Spirometer." Therefore, a table of acceptance criteria and reported device performance with specific values cannot be fully populated from the given text.

Based on the provided information, here's a breakdown of the requested details:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The specific numerical values for accuracy and repeatability limits, as defined by the ATS 1994 update for a monitoring device, are not present in the provided text. The document only confirms the device met these unstated recommendations.

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

• Sample Size: Not specified in the provided text. The document mentions "testing the OneFlow FVC" but does not give a number of devices or data points in the test set.
• Data Provenance: The testing was "Non-clinical performance data" compiled by the applicant (Clement Clarke Int. Ltd) in the United Kingdom. It is a retrospective evaluation of the device's performance against established standards.

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

• Number of Experts: Not applicable. The ground truth for this spirometer performance evaluation is not based on expert consensus on image interpretation or clinical diagnosis. It's based on adherence to technical standards.
• Qualifications of Experts: Not applicable. The evaluation relies on the methods described in a recognized technical standard (ATS "Standardization of Spirometery" 1994 update) rather than a panel of clinical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This type of performance testing involves objective measurements against established technical standards, not subjective assessments requiring adjudication by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the device against technical standards, not on human reader performance with or without AI assistance.
• Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, the study evaluates the standalone performance of the OneFlow FVC device. The testing described focuses solely on the device's ability to accurately measure spirometry parameters according to the ATS 1994 update, without human interpretation in the loop as part of the performance evaluation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is based on technical standards and simulated conditions. Specifically, performance was evaluated "in accordance with the methods described in the American Thoracic Society's document 'Standardization of Spirometery' 1994 update," with a focus on meeting the "limits for a monitoring device during evaluation." Additionally, a "simulation of three years typical use" was conducted as part of the durability ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The OneFlow FVC is a measurement device, not an AI/ML algorithm that requires a training set. The device's design and calibration would be based on engineering principles and established physical processes, not a data-driven training set in the typical AI sense.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device. The device's functionality is based on its hardware design (venturi pressure system, microprocessor, sensors) and software algorithms for measurement, which are calibrated and developed according to engineering specifications and industry standards.

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The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.

EyeCap Imaging System

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the EyeCap Imaging System, which primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested table or answer the specific questions about the study, sample sizes, ground truth, or expert qualifications.

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The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.

AirZone Peak Flowmeter

This document is a 510(k) premarket notification for the AirZone Peak Flowmeter, which is a device for measuring peak expiratory flow rate. It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the format requested. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, but it does not provide performance data or study details. Therefore, I cannot extract the requested information from this document.

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The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient.

Some uses for the device are :-

1. Diagnosis of Nasal Obstruction
2. Assessment of Response to Nasal Provocation
3. Home Monitoring of PNIF
4. Oral Inspiratory Flow Measurement

The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions.

The provided document focuses on the FDA 510(k) submission for the "IN-CHECK Inspiratory Flowmeter". It primarily addresses the regulatory approval process and indications for use. The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in the detail required to populate the requested table and answer the specific study questions.

The document states:

• Safety Problems: "No safety problems should be experienced during use of the device for its intended purpose, and none have been reported for either the IN-CHECK OR YOULTON INSPIRATORY MINI." This indicates a lack of reported issues rather than a rigorous study proving safety against specific criteria.
• Effectiveness: The FDA determined the device to be "substantially equivalent" to predicate devices. This regulatory pathway does not typically require new clinical studies to prove effectiveness against specific quantitative acceptance criteria, but rather demonstrates that the new device is as safe and effective as a legally marketed device.

Therefore, since the document does not provide the requested details, I cannot complete the table or answer the specific study questions.

Information NOT available in the provided text:

• A table of acceptance criteria and reported device performance (e.g., accuracy, precision).
• Sample sizes for test sets, training sets, or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
• Specific ground truth types (beyond general safety and equivalence to predicate devices).

To answer your questions, additional documentation regarding the performance testing of the IN-CHECK Inspiratory Flowmeter would be required.

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Not Found

Not Found

The provided document is a Pre-Market Notification Certification and Summary for medical devices (VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS). It does not contain any information about acceptance criteria or a study proving device performance in the way requested for AI/machine learning model evaluation.

This document focuses on:

• Certification of awareness regarding safety and effectiveness problems for the listed devices.
• Assertions about the absence of reported safety problems for the intended use.
• Confirmation of compliance with a specific safety standard (International BS EN 1SO 60601-1).
• Instruction on general medical hygiene and sterilization of the mouthpiece.
• Identification of low battery power as an effectiveness issue, with a visual indicator provided.

Therefore, I cannot extract the requested information (Table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, or training ground truth establishment) from this document.

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