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TD-7301 Spirometer is intended to monitor Peak Expiratory Flow (PEF), Forced Expiratory Volume (FEV) in home and professional healthcare environments.

The device is designed for use with children over 5 years old, adolescent and adult subjects.

The TD-7301 Spirometer is a portable and handheld electronic spirometer used to measure expired Peak Expiratory Flow (PEF), Forced Expiratory Volume in one second (FEV1), Forced Expiratory Volume in six second (FEV6) and their ratio (FEV1/FEV6).

The users can transfer their measurement results from the TD-7301 Spirometer to iFORA smart on their mobile devices via Bluetooth. The iFORA smart provide an overview of users record with historical data and trend graph.

The TD-7301 Spirometer hardware is identical to the TD-7301 Peak Flow Meter cleared under K222810 (reference device).

The provided text describes the acceptance criteria and the study that proves the TD-7301 Spirometer meets those criteria. However, it does not involve AI or human readers assisted by AI, as the device is a diagnostic spirometer without AI components. Therefore, some of the requested information (e.g., number of experts for ground truth establishment, MRMC study, standalone AI performance) is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details performance evaluation against recognized standards.

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

The document does not specify exact sample sizes for the performance evaluations (e.g., number of spirometry maneuvers or individual devices tested). It generally states that "performance evaluation of the TD-7301 Spirometer was conducted."

Data provenance (e.g., country of origin, retrospective/prospective) is not detailed for the performance studies described. The manufacturer is based in Taiwan (GOSTAR Co., Ltd, New Taipei City, Taiwan).

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

This information is not applicable. The TD-7301 Spirometer is a direct measurement device for pulmonary function, not an AI or imaging device requiring expert interpretation for ground truth. The acceptance criteria are based on adherence to international standards for spirometry measurements (ATS, ISO 26782, ISO 23747).

4. Adjudication Method for the Test Set

This information is not applicable as the device measures objective physiological parameters, not interpretations requiring adjudication.

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

This is not applicable as the TD-7301 Spirometer is a diagnostic measurement device and does not involve AI assistance for human readers.

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

This is not applicable, as the device is a physical spirometer, not an algorithm, that measures physiological parameters. The performance evaluation focuses on the accuracy and reliability of its measurements against established standards.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation of the TD-7301 Spirometer is based on established international standards for spirometry measurement:

• American Thoracic Society (ATS) Document "Standardization of Spirometry -2019": This document provides expert consensus and guidelines for how spirometry should be performed and measured.
• ISO 26782:2009 (Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans): This standard defines accuracy and performance requirements for spirometers.
• ISO 23747:2015 (Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans): This standard defines accuracy and performance requirements for peak expiratory flow meters.

The device's measurements (PEF, FEV1, FEV6) are quantitative and compared against the specifications outlined in these standards.

8. The Sample Size for the Training Set

This is not applicable as the TD-7301 Spirometer is not an AI/machine learning device that requires a "training set." Its measurements are based on a physical rotor stator design and established principles of operation for flow measurement, not data-driven learning.

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

This is not applicable as there is no "training set" for this type of device.

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The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4. The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals. The EasyOne Sky is used in hospitals, clinical settings, and in occupational medicine.

The product EasyOne Sky (EOS) is a medical electrical equipment for spirometry testing. It consists of the hand-held TrueFlow Sensor FT (SeNe) comprising an ultrasonic flow sensor that conducts air flow measurements, the application EasyOne Mobile (EOMA), and the breathing mouthpiece EasyOne FlowTube (EOFT). The EOS can be used with the optional accessories EasyOne Filter FT and a nose clip.

Key functions:

• . The key function of the TrueFlow Sensor FT (SeNe) is to acquire patient flow data by measuring transit-times of ultrasonic pulses and to send data wireless (via Bluetooth Low Energy) to the host system. The measurements and data transmission are performed by the firmware of the SeNe defined as MDSW with clinical functions.
• . The key function of the application EasyOne Mobile (EOMA) is to trigger the start of the measurement with the TrueFlow Sensor FT, to communicate with it and to visualize the data received from it.
• . The EasyOne FlowTube (EOFT) is an individually packaged, single-patient-use breathing tube and is intended to canalize patient breath through the flow sensor tube. The EOFT is an essential accessory to EOS.

The EasyOne Sky spirometer, as described in the provided 510(k) summary, underwent various non-clinical tests to demonstrate its substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies performance testing in accordance with ISO 26782:2009 for 13 waveforms. This refers to a standardized set of flow-volume and volume-time waveforms designed to test spirometer performance across a range of physiological conditions. The provenance of these waveforms is standardized and not patient-specific. The document does not specify additional clinical test set sizes or their provenance (e.g., country of origin, retrospective/prospective). The assessment relies heavily on compliance with recognized performance standards rather than a separate clinical test set of patient data.

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

The ground truth for the performance testing is established by international spirometry standards (ATS/ERS/ISO), which define the expected values for the 13 waveforms used in testing. These standards are developed by expert committees, but the document does not mention individual experts specifically establishing ground truth for this particular device's test set, as it relies on compliance with pre-defined standard waveforms.

4. Adjudication method for the test set

No specific adjudication method (like 2+1, 3+1) is mentioned for a test set. The evaluation is based on the device's technical performance against established international standards for spirometry.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. The device is a diagnostic spirometer, not an AI-assisted diagnostic tool that interprets images or signals requiring human reader input for comparison.

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

Yes, a standalone performance assessment was effectively done. The spirometer's core function is to measure and calculate spirometry parameters based on patient breathing. The "Performance" section explicitly states compliance with established spirometry standards (ATS/ERS/ISO), which are machine-based performance tests using standardized waveforms. The device's firmware performs the measurements and calculates parameters independently, and this is what was tested against international accuracy standards.

7. The type of ground truth used

The ground truth used for performance testing (accuracy, repeatability, linearity) is based on established spirometry standards and guidelines (ATS/ERS/ISO). Specifically, ISO 26782:2009 includes defined "reference waveforms" for evaluating spirometers, which serve as the ground truth against which the device's measurements are compared.

8. The sample size for the training set

The document does not provide information about a "training set" in the context of machine learning. The device is a traditional medical device that performs measurements and calculations based on physics (ultrasonic transit-time measurement) and programmed algorithms derived from clinical standards, not an AI/ML-based device that requires a training set of data.

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

As there is no mention of a machine learning "training set," the concept of establishing ground truth for it is not applicable here.

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The alveoair Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged ≥ 22 years by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer is not intended for use during patient transport.

The alveoair Digital Spirometer is used to test lung function in people of all ages ≥ 22 years. It is intended to be used by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer was designed, developed, and manufactured at Roundworks Technologies Pvt Ltd. The model number is indicated below: ALV002 alveoair Digital Spirometer Digital Spirometer to measure lung function parameters. The alveoair Digital Spirometer system includes: alveoair Digital Spirometer, alveoMD mobile application, alveofit API Cloud server backend. The alveoair Digital Spirometer is intended to be used and compatible only with the flowMIR disposable turbine and cardboard mouthpiece manufactured by the Medical International Research s.r.l. The accessories are 510k cleared under K061712 and it is single-use disposable. Roundworks Technologies Pvt Ltd recommends the user to purchase the sinqle-use disposable flowMIR turbine on their own. One sample piece of the flowMIR (Ref. code: 910004) disposable turbine sensor and disposable cardboard mouthpiece is provided in the packaging. Roundworks recommends that the user purchase the same model turbine and mouthpiece from Medical International Research s.r.l. for further use. The alveoair digital spirometer is available in two different colors. The internal components, software, and function remain the same for both devices. The only difference is the color of the case; one is completely black and the other is a combination of black and white. The alveoair Digital Spirometer is used in combination with a turbine and mouthpiece. It utilizes a smartphone with a dedicated mobile application (alveoMD) and a cloud server (alveoFit) to view and store spirometer readings. This portable spirometer operates on the principle of infrared interruption. To perform a test, the user inhales and exhales air through the mouthpiece, which then flows into the turbine. The turbine's propeller rotates in both clockwise and counterclockwise directions, depending on the airflow. The firmware within the device calculates a series of volume and flow coordinates, in liters with respect to time in seconds, every time an interrupt data is received from the IR sensor. This process continues for 20 seconds or until the flow change calculated is less than 0.025 liters per second. When the patient inhales/exhales air into the spirometer during the standard or full loop tests. Once the test is completed, all coordinates are transferred to the mobile application using BLE. From there, the data is uploaded to the alveofit API Cloud server via the internet. For the alveoMD app, an internet connection is required to initiate the spirometry test. The alveoFit cloud server takes in the coordinates to calculate all lung parameters. Once the process is completed, a test report will be generated and displayed in the alveoMD mobile application. The internal program performs all calculations for measurements to meet ATS/ERS guideline standardization of spirometry 2019.

The provided text does not contain detailed information about specific acceptance criteria for the alveoair Digital Spirometer's performance or a study proving that the device meets these criteria in the way typically found for AI/ML-based medical devices (e.g., sensitivity, specificity, or performance against human readers).

The document focuses on demonstrating substantial equivalence to a predicate device (Air Next, K183089) and a reference device (Spirobank G, K072979) primarily through comparison of technical specifications, intended use, and adherence to relevant medical device standards.

However, based on the information provided, I can infer some aspects of what would constitute "acceptance criteria" for a spirometer and what studies were referenced to show compliance.

Here's an analysis based on the provided text, addressing the points where information is available or can be reasonably inferred within the context of a spirometer's regulatory submission:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria for the alveoair Digital Spirometer are primarily derived from the industry standards it claims to comply with, particularly ISO 26782:2009 for spirometers and ISO 23747:2015 for peak expiratory flow meters, as well as the ATS/ERS 2019 guidelines. These standards define the required accuracy and precision for spirometry measurements.

Table of Acceptance Criteria (Inferred from Standards Compliance) and Reported Device Performance:

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The spirometer (Air Smart Extra) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a spirometer. It confirms the device's substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.

The spirometer is used to detect the ventilatory conditions of patients using a flow sensor. Basic test items include: Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), Maximum Ventilator Volume (MVV), and Minute ventilation (MV). The device also provides bronchial diastolic and bronchial provocation tests comparison before and after medication along with time-volume and time-flow curves of the above tests.

The device comes in two models: LA104 and LA105. There are no differences between the two models apart from a minor software function. LA104 includes software incentive animations to encourage children to follow breathing instructions. The spirometer (model: LA104, LA105) consists of the main body, handle, power adapter and a single-use flow sensor. In order to conduct simple spirometry testing, the spirometer is used with a commercially available single-use disposable filter with integrated mouthpiece. This device is compatible with 30mm diameter filters.

The fundamental technology to measure flow is differential pressure. While the patient breathes, the air flows through both ends of the flow probe and produces different pressures. Then the sensor detects the pressure gap between both ends and converts it to electrical signals. The electrical signals are converted into digital signals of the pressure gap. Then digital signals are input into the computer system, which outputs values of pulmonary function related parameters after digital signal processing and data analysis.

The provided document is a 510(k) summary for a Spirometer (models LA104, LA105). It outlines the device's technical specifications, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating equivalence to the predicate device (CardioTech Spirometry Model System, K090646) and compliance with recognized standards. The acceptance criteria are implicit in these standards and the predicate comparison.

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Safey Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.

Safey Pocket Spirometer is a prescription use medical device to help respiratory patients keep track of their lung health. This device is a portable spirometer intended for above 5 years of age. Safey Pocket Spirometer is a pocket device intended for home use and operates on two AAA type standard alkaline batteries. Safey Pocket Spirometer works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to interpretable spirometry values. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User.

The provided document, a 510(k) Summary for the Safey Pocket Spirometer, outlines the device's technical characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device (Spirobank G, K072979). While it details various non-clinical tests and adherence to standards, it does not provide acceptance criteria tables or the specific results of the ATS/ERS flow/volume simulator test in a format that directly addresses the prompt's request for "acceptance criteria and reported device performance" with specific numerical values for metrics like accuracy, precision, sensitivity, or specificity.

The document states: "The Safey Pocket Spirometer device was tested on a Flow/Volume Simulator according to American Thoracic Society (ATS) Document 'Standardization of Spirometry - 2005'. The results obtained show that Safey Pocket Spirometer display results within ATS limits." This implies that the device met the ATS standards for spirometry accuracy, but the numerical acceptance criteria and the actual performance results are not explicitly tabulated.

Therefore, the following response will infer some acceptance criteria based on the comparison table and general industry standards (ATS/ERS) and report the device's performance as "meets ATS limits" where specific numbers are not provided. Much of the requested information (e.g., sample size for test/training sets, number and qualifications of experts, adjudication methods) is absent from this 510(k) summary, as these details are typically required for studies involving qualitative or diagnostic AI/ML models with human performance components, rather than a quantitative measurement device like a spirometer.

Acceptance Criteria and Device Performance for Safey Pocket Spirometer

The Safey Pocket Spirometer is a diagnostic spirometer. The primary performance evaluation for such devices revolves around the accuracy of flow and volume measurements against established standards, such as those from the American Thoracic Society (ATS) and European Respiratory Society (ERS).

1. Table of Acceptance Criteria and Reported Device Performance

Given the information provided in the 510(k) summary, the acceptance criteria are implicitly based on the ATS/ERS standards, and the reported performance is that the device meets these standards. The comparison table with the predicate device also indicates shared performance characteristics.

Note: The document only states that "The results obtained show that Safey Pocket Spirometer display results within ATS limits." It does not provide the exact numerical results for accuracy beyond stating that it meets the accepted limits.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a separate "test set" sample size in terms of human subjects or distinct spirometry measurements. The performance testing was conducted on a "Flow/Volume Simulator." The number of samples/measurements performed on this simulator is not specified.
• Data Provenance: The testing was non-clinical, done on a simulator, and focused on device accuracy rather than patient data. The device manufacturer, Safey Medical Devices Pvt Ltd, is based in Pune, Maharashtra, India.

3. Number and Qualifications of Experts for Ground Truth

This type of device (a diagnostic spirometer) does not typically require human experts to establish "ground truth" in the same way an AI/ML diagnostic imaging device would. The ground truth for spirometry measurements is established by physical standards and calibrated simulators, often traceable to national or international metrology standards. Therefore, the concept of "experts establishing ground truth" in the context of human interpretation is not directly applicable here.

4. Adjudication Method for the Test Set

Not applicable. As the testing was conducted on a flow/volume simulator, no human adjudication was involved in generating the "ground truth" measurements.

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

Not applicable. This is a standalone measurement device, not an AI-assisted diagnostic tool designed to improve human reader performance. Its performance is validated against physical standards, not human interpretations.

6. Standalone Performance (Algorithm Only)

The provided data describes the standalone performance of the device (Safey Pocket Spirometer) and its integrated software. The device's ability to accurately measure and report spirometry values (volume, flow, etc.) is the core of its standalone performance. The testing against ATS/ERS standards on a flow/volume simulator represents this standalone (algorithm/device only) validation.

7. Type of Ground Truth Used

The ground truth used was based on physical standards and calibrated spirometry flow/volume simulators. These simulators are designed to generate precise and known flow and volume patterns, serving as the "true" values against which the device's measurements are compared. The reference for these ground truth values is the American Thoracic Society (ATS) Document "Standardization of Spirometry - 2005."

8. Sample Size for the Training Set

Not applicable/Not specified. This device operates on an "infrared interrupt" concept to measure flow and volume, which relies on physical principles and calibration rather than machine learning models that require large training data sets. Therefore, there's no "training set" in the context of an AI/ML algorithm.

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

Not applicable, as there is no training set for a machine learning algorithm. The device's method of operation is based on established physics and engineering principles, not learned patterns from data.

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MEDINET INCENTIVE SPIROMETER – RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser.
MEDINET INCENTIVE SPIROMETER - RESPIPROGRAM is intended for single use in a hospital or home care setting.

The RESPIPROGRAM is an inspiratory device used as breathing exerciser; RESPIPROGRAM is a FLOW exerciser.
The RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser. It is intended for single-patient, single use both in a hospital or for home care therapy.
RESPIPROGRAM is a single patient, single use, disposable, non-sterile device.
RESPIPROGRAM is a single use device that allows the patient to indicate visually the capacity of inhaling, even though RESPIPROGRAM doesn't have a specific measuring function. The device is a stimulator for inspiration; therefore it is indicated in all situations for when it is necessary to stimulate the patient's inhalation, under the prescription of a physician. The patient inspires through a mouthpiece that is connected to 3 chambers that have 3 balls of different colors (red, yellow and green) each one indicating a different approximate flow rate (respectively 600, 900 and 1200 ml per second).

This document describes the Medinet Incentive Spirometer - Respiprogram, an inspiratory deep breathing positive exerciser. The information provided outlines the device's technical specifications and the tests conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The data provided for the Medinet device under various humidity conditions are:

• Low humidity (cc/sec):
  • 600 cc/sec: 604.6 ± 5.5
  • 900 cc/sec: 925.2 ± 3.28
  • 1200 cc/sec: 1222.8 ± 10.0
• High humidity (cc/sec):
  • 600 cc/sec: 593.5 ± 4.9
  • 900 cc/sec: 887.3 ± 3.7
  • 1200 cc/sec: 1177.3 ± 7.5
    These values are within a ±5% range of their nominal flow rates (e.g., 5% of 600 is 30, and 604.6 is certainly within 570-630). The predicate device's specified accuracy of +/- 5% is shown to be met by the Medinet device. |
    | Resistance (Drop Test) | No breakage or crack | Met Predetermined Criteria: "The results showed that the samples tested met the pre-determined acceptance criteria without any breakage or crack." |
    | Biocompatibility | Conforming to ISO 10993 testing | Conforming to ISO 10993 testing:
• Cytotoxicity (ISO 10993-5): Performed
• Irritation (ISO 10993-10): Performed
• Sensitization (ISO 10993-10): Performed |

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

The document does not explicitly state the numerical sample size for the test set used in the flow accuracy or drop tests. It refers to "new and aged samples" and "samples tested" without providing a specific count.

• Data Provenance: The tests were conducted internally by Medinet SRL to compare their device with the predicate device (BESMED TriBall). The country of origin of the data is Italy (Medinet SRL is located in Milan, Italy). The studies appear to be prospective comparative tests designed for this 510(k) submission.

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

This question is not applicable to the type of device and study described. The Medinet Incentive Spirometer is a mechanical device, and its performance (flow accuracy, structural integrity, biocompatibility) is measured against objective technical standards and a predicate device, not against expert interpretation of medical images or symptoms. Therefore, no medical experts were involved in establishing "ground truth" for the technical performance tests.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic or prognostic tasks. Since this device's performance is measured objectively against technical specifications, no adjudication was necessary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of the device on human reader performance. The Medinet Incentive Spirometer is a therapeutic/exerciser device, not a diagnostic one that would involve human "readers" interpreting output.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a mechanical incentive spirometer, not an algorithm. Its "standalone performance" is its inherent mechanical function as described by the flow accuracy and physical integrity tests.

7. The Type of Ground Truth Used:

The "ground truth" for these tests consisted of:

• Technical Specifications: The defined flow rates (600, 900, 1200 ml/sec) and the accepted accuracy tolerance (±5%).
• Predicate Device Performance: The predicate device's established performance served as a benchmark for comparison during the comparative flow accuracy and drop tests.
• ISO 10993 Standards: For biocompatibility, the ground truth is compliance with the specified parts of the ISO 10993 series.

8. The Sample Size for the Training Set:

This question is not applicable. The Medinet Incentive Spirometer is a mechanical device and does not involve AI algorithms that require a "training set" of data.

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

This question is not applicable, as there is no training set for a mechanical device.

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The EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinical settings in occupational medicine.

The ndd EasyOne Air is a diagnostic spirometer.

In order to conduct simple diagnostic spirometry testing, the EasyOne Air is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (EasyOne Flow Tube).

The sensor is an ultrasound flow sensor that measures pulse transit-time to determine gas flow velocity and volume, as well as molar mass of the gas. The collected data is used for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.

This document describes the EasyOne Air Spirometer. However, it does not contain the specific information required to complete all parts of your request, especially regarding a clinical study with acceptance criteria and reported device performance in the format you provided. The document primarily focuses on demonstrating substantial equivalence to a predicate device for FDA 510(k) clearance.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document mentions "Dynamic wave form testing and comparative testing with a commercially available ndd Spirometer confirmed that the EasyOne Air Spirometer meets the spirometry recommendations for accuracy and precision published by the American Thoracic Society (ATS)."

However, it does not provide a table of specific acceptance criteria (e.g., specific thresholds for FVC accuracy) or the numerical reported device performance in a format that could be directly extracted into such a table. It only states that the device "meets the spirometry recommendations."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is "Dynamic wave form testing and comparative testing," which implies laboratory testing and comparison against a predicate device, rather than a clinical study with human subjects whose data provenance would be relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided in the document. The testing was against established spirometry recommendations and comparison to a predicate device, not against ground truth established by experts interpreting outputs from the device in a clinical context.

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

This information is not applicable and therefore not provided. No adjudication method is described because there's no expert interpretation of device outputs.

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

This information is not applicable and therefore not provided. The EasyOne Air Spirometer is a diagnostic device for measuring lung function, not an AI-powered image analysis tool that would typically involve human readers and efficacy studies like MRMC.

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

The document describes the performance of the "EasyOne Air Spirometer" itself, which is a standalone device in the context of spirometry. It measures and processes data without human input affecting the measurement itself. The results are then displayed for interpretation by healthcare professionals. So, in a sense, its primary function is "standalone" (algorithm only) in generating the spirometry measurements. However, the term "standalone performance" often refers to an AI algorithm's performance before human review in a diagnostic workflow, which isn't directly analogous here.

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

The "ground truth" for the performance claims appears to be:

• ATS (American Thoracic Society) spirometry recommendations for accuracy and precision.
• Comparison to the predicate device (ndd EasyOne Spirometer).

8. The sample size for the training set

This information is not applicable and therefore not provided. The EasyOne Air Spirometer is a measurement device, not an AI/ML model that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reason as point 8.

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The Besmed Volumetric Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.

The Besmed Volumetric Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a ball and piston which upon the patient inhaling, creates a vacuum, which causes the ball and piston to rise, the piston reflects the inspiratory volume while the ball is an indicator for the user to maintain the optimum inspiratory flow rate. Two (2) models are offered - 2500 cc and 5000 cc. It is a single patient, multi-use, disposable, non-sterile device. The mouthpiece may be removed and cleaned by the user as needed but the main device is not to be cleaned.

As a patient improves their respiratory capacity or gets stronger they improve their inspiratory volume raising the piston. The principle of the ball indicator is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers".

The Besmed Volumetric ICS achieves the therapeutic intent by helping the patient to improve their inspiratory volume. It is a relative improvement device that as described offers the patient the "incentive" to improve. This is the identical therapeutic intent of the predicate volume based incentive spirometer.

The provided document describes the 510(k) premarket notification for the "Besmed Volumetric Incentive Spirometer." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study proving device acceptance criteria in the context of diagnostic accuracy or comparative effectiveness with human readers.

Therefore, many of the requested sections related to clinical study design, sample sizes for test/training sets, expert adjudication, and MRMC studies are not applicable to the information contained within this 510(k) summary. This document primarily details non-clinical performance and comparisons to a predicate device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are derived from the observed performance of the proposed device and are compared to the predicate's (Hudson RCI K801199), which reported an accuracy of ~21%. The Besmed device's performance is stated as "equivalent (or better)."

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

The document states: "Multiple samples of each device were tested multiple times and then evaluated for consistency of performance." However, specific sample sizes (number of devices, number of tests per device) for the non-clinical performance evaluation are not explicitly provided.

Data provenance: Non-clinical testing appears to have been conducted by the manufacturer, Besmed Health Business Corp. The country of origin of the data is not explicitly stated beyond the manufacturer's location (Taiwan). It is a retrospective analysis of device performance against internal specifications and comparison to a predicate device.

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

Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.

4. Adjudication method for the test set

Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.

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 document describes a physical medical device (incentive spirometer), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a physical medical device; there is no "algorithm only" performance separate from the device's inherent mechanical function.

7. The type of ground truth used

For volume accuracy, the ground truth would be the accurately measured volume of air moved by a calibrated testing system.

For age testing and environmental testing, the ground truth is the "performance specifications" that the device is expected to meet both before and after exposure to certain conditions.

8. The sample size for the training set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

Not applicable. See point 8.

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The Besmed Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.

The Besmed TriBall Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a series of balls which upon the patient inhaling, creates a vacuum, which causes the balls to rise, they reflect the inspiratory flow rate in cc/sec (600, 900 and 1200). It is a single patient, multi-use, disposable, non-sterile device. As a patient improves their respiratory capacity or gets stronger their inspiratory flow rate raises the balls. The principle is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers". The TriBall achieves the therapeutic intent by helping the patient to improve their inspiratory flow rate. It is a relative improvement device that as described offers the "incentive" to improve. This is the identical therapeutic intent of all predicate flow / volume based incentive spirometers.

The provided text describes the 510(k) summary for the Besmed TriBall Incentive Spirometer. I will extract the requested information based on the content.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states, "Multiple samples of each device were tested multiple times." However, specific numerical sample sizes for devices or tests, or data provenance (country of origin, retrospective/prospective) are not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   This device is a physical medical device (incentive spirometer), not an imaging or diagnostic AI-driven device that typically requires expert-established ground truth. Therefore, this information is not applicable and not provided in the document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as this is a performance test for a physical device, not an assessment requiring expert adjudication of data. The performance was measured directly against technical specifications.

4. 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 is a physical medical device, not an AI-assisted diagnostic tool involving human readers/interpreters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The "performance testing" described is for the physical device itself, in terms of its inspiratory rate/volume accuracy, and its ability to withstand environmental conditions, not for an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for the performance testing of the incentive spirometer was based on pre-defined technical specifications for inspiratory rate/volume accuracy (+/- 5%) and the ability to maintain performance after environmental stressors. This is a direct measurement against engineering and design standards, not a clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:
   Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for the physical product’s performance characteristics.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this type of device.

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