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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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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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The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• · Movement

The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.

• · Respiration rate
• · Non-invasive blood pressure
• · Lung function & spirometry
• · Weight

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight.

The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT).

While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.

In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.

The provided document does not contain detailed acceptance criteria or the specific study details for validating the device's performance against such criteria. Instead, it lists various "Test Names" and "Test Descriptions" which broadly indicate areas of testing (e.g., electrical safety, EMC, pulse rate testing, SpO2 testing, respiration rate testing, temperature measurement accuracy). However, it does not specify quantitative acceptance thresholds for these performance metrics, nor does it provide the reported device performance in those quantitative terms.

For example, for "Pulse Rate Testing," the description mentions "Validation of the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007." While this indicates the standards followed, it doesn't state what specific accuracy (e.g., within X beats per minute) was achieved or was the acceptance criterion. The "Results" column consistently states "Passed," but without the specific acceptance criteria, it's impossible to determine the benchmark used for passing.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the absence of the requested information:

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

   Performance Metric	Acceptance Criteria	Reported Device Performance
   Electrical Safety	Unspecified; adherence to IEC 60601-1	"Passed"
   EMC	Unspecified; adherence to IEC 60601-1-2	"Passed"
   Alarm Testing	Unspecified; adherence to IEC 60601-1-8	"Passed"
   Pulse Rate Accuracy	Unspecified; adherence to ISO 80601-2-61 and FDA Guidance 2007	"Passed"
   SpO2 Accuracy	Unspecified; adherence to ISO80601-2-61 and FDA Guidance 2013	"Passed"
   Respiration Rate Accuracy	Unspecified; comparison to end-tidal CO2	"Passed"
   Temperature Measurement Accuracy	Unspecified; adherence to ISO 80601-2-56	"Passed"
   Battery Life	Unspecified	"Passed"
   PDU Buffering Time	Unspecified	"Passed"
   Usability	Unspecified; adherence to IEC 62366 and IEC 60601-1-11	"Passed"
   Device Ship/Transport	Unspecified; adherence to ASTM D4169	"Passed"
   Biocompatibility	Unspecified; adherence to ISO 10993-1	"Passed"
   Wireless Coexistence	Unspecified	"Passed"
   System V&V	Unspecified	"Passed"
   Software V&V	Unspecified	"Passed"

2. Sample size used for the test set and the data provenance: This information is not provided in the document. The document states "No clinical studies were conducted as part of submission to prove substantial equivalence." The non-clinical tests mention "the system was tested," but do not specify sample sizes for these tests (e.g., how many subjects for pulse rate and SpO2 accuracy, or how many devices for other tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.

4. Adjudication method for the test set: This information is not provided.

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 provided. The device is a "Wearable Health Monitoring System" and the testing described is primarily about the accuracy of its vital sign measurements and compliance with various standards, rather than evaluating AI assistance for human readers in a diagnostic capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes various "non-clinical tests" and "software verification and validation testing" which would fall under standalone performance. However, specific performance metrics quantifying the algorithm's output (e.g., sensitivity, specificity, accuracy %) against a ground truth are not provided. The results are merely "Passed" for general compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physiological parameters, the ground truth would typically be established by a reference method. The document mentions "in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff" for pulse rate and SpO2, and "comparison to respiration rate measured via end-tidal CO2" for respiration rate. These represent established reference methods for ground truth, but the details of their application in the study (e.g., specific devices used for reference, blinded measurements) are not given. For other tests like electrical safety or EMC, the ground truth is adherence to the specified standard.

8. The sample size for the training set: This information is not provided. The document does not discuss a training set, as it mainly focuses on verification and validation testing rather than the development of AI/ML models that would require training data.

9. How the ground truth for the training set was established: This information is not provided, as a training set is not discussed.

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The IDM100 is for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years, except as noted below), adolescent (between 13 years and 17 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous monitoring.
Vital Sign and Cardiopulmonary Tests:
• Signal acquisition and display for 12 lead ECG waveform and 3-lead thythm for evaluation and diagnosis of patient cardiac function. ECG calculation of diagnostic measurements is provided for adult patients only.
• Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.
• Patient temperature provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal, and axillary temperatures.
• SpO2 Oximeter for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2), wulse rate, and optional Respiratory Rate.
• Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.
• Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient.
• Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient.
• Manual interface for height, weight, respiratory rate, and other manually captured patient information.

The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection. The IDM100 applications range from routine screening in ambulatory care facilities, to physician offices, hospitals and patient homes with traveling HCP (Health Care Professional) or by the patient (layperson). (See indication of use for limitations.) The diagnostic capabilities are designed for the clinical populations described in the indications, including neonatal, pediatric, and adult.

Here's the information regarding the IDM100 device's acceptance criteria and the study that proves it meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Spirometry: Not explicitly stated, but the testing was "performed according with American Thoracic Society (ATS) Standards."
   • Audiometry: Not explicitly stated.
   • ECG Measurements: Not explicitly stated, but involved "three methods: CSE Database Verification, Data Collection, and a Clinical Verification."
   • NIBP Device Evaluation: Not explicitly stated, involved "visual inspections and testing."
   • Tympanic Thermometer: Not explicitly stated, involved "accuracy testing."
   • Low Perfusion SpO2/Pulse Rate Accuracy: Not explicitly stated, involved a "Simulated Low Perfusion Saturation And Pulse Rate Accuracy Study Using A Pulse Simulator."
   • Data Provenance: Not specified, but given the nature of the device and testing, it's likely a mix of lab-based/simulated data and potentially clinical data (for ECG clinical verification). The document does not specify country of origin or whether it was retrospective or prospective.

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

   • Not explicitly stated. Ground truth for most tests appears to be based on established industry standards and reference instruments (e.g., ATS standards for spirometry, ANSI/ASA for audiometers, CSE Database for ECG, EN standards for NIBP, and reference devices for temperature/SpO2). For "Clinical Verification" of ECG, it implies expert review, but the number and qualifications are not detailed.

3. Adjudication method for the test set:

   • Not explicitly stated. The document simply reports that "results were satisfactory" or "validated" against specified standards or reference data.

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:

   • No MRMC comparative effectiveness study is mentioned. This device is a vital signs monitor and diagnostic tool, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies involving human readers and AI. The device's functionality is about data acquisition and display, with some automated measurements (like ECG diagnostics for adults, MAP calculation), not interpretation by human readers that would be augmented by AI in the context of a typical MRMC study.

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

   • The document implies standalone performance testing against standards for each of its functions (ECG measurements, Spirometry, Audiometry, NIBP, etc.). The device itself performs these measurements or calculations without explicit human intervention in the measurement acquisition and initial processing phase, though a healthcare professional is responsible for operating it and interpreting the results.

6. The type of ground truth used:

   • Reference Standards/Devices: For spirometry, ATS standards. For audiometry, ANSI/ASA S3.6-2010. For ECG, CSE Database and clinical verification. For NIBP, EN1060-3. For temperature and SpO2/pulse rate, accuracy testing against reference (simulators or calibrated devices).
   • Clinical Verification: Mentioned for ECG, implying comparison to established clinical methods or expert opinion.

7. The sample size for the training set:

   • Not applicable/Not mentioned. The document describes a medical device for vital sign measurement and diagnostic tests, not a machine learning or AI algorithm that would typically require a training set in the conventional sense for its core functionality. The "Software Validation" refers to general software engineering principles and risk assessment, not AI model training.

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

   • Not applicable, as no training set for an AI model is described.

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The Gelflex Synergy (hioxifilcon B) Soft Contact Lens (spherical and toric in both clear or blue visitint) is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The Gelflex Synergy (hioxifilcon B) Spherical Lens may be worn by persons who have astigmatism of 1.50 diopters or less which does not interfere with visual acuity. The Gelflex Synergy (hioxifilcon B) Toric Lens may be worn by persons who have astigmatism of up to 4.50 diopters.

The Gelflex (hioxifilocn B) Soft Contact Lens (Triton Translating Bifocal and Triton Translating Toric Bifocal in both clear or blue visitint) is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic and non-aphakic persons with non-diseased eyes. The Gelflex (hioxifilcon B) Triton Translating Bifocal Lens may be worn by persons who have astigmatism of 0.50 diopters or less which does not interfere with visual acuity. The Gelflex (hioxifilcon B) Triton Translating Toric Bifocal Lens may be worn by persons who have astigmatism of up to 6.00 diopters.

The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your care practitioner.

Soft (hydrophilic) Contact Lens

I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for contact lenses. It does not contain information about acceptance criteria or a study that proves a device meets such criteria, nor does it include details about artificial intelligence, human readers, or ground truth establishment. Therefore, I cannot generate the requested table and information based on the given input.

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