Search Results
Found 1 results
510(k) Data Aggregation
(147 days)
TD-7301 Spirometer (TD-7301)
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.
| Characteristic | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| FEV1 Accuracy | Complies with American Thoracic Society (ATS) Document "Standardization of Spirometry -2019" and ISO 26782:2009 | ± 2.5% or +0.05 L (meets ISO 26782) |
| FEV6 Accuracy | Complies with American Thoracic Society (ATS) Document "Standardization of Spirometry -2019" and ISO 26782:2009 | ±2.5% or +0.05 L (meets ISO 26782) |
| Repeatability (FEV) | ISO 26782:2009 | ±2.5% or 0.05 L (meets ISO 26782) |
| Linearity (FEV) | ISO 26782:2009 | ±2.5% (meets ISO 26782) |
| Impedance (FEV) | ISO 26782:2009 | within 0.15 kPa/(L/s) (meets ISO 26782) |
| PEF Accuracy | Complies with American Thoracic Society (ATS) Document "Standardization of Spirometry -2019" and ISO 23747:2015 | ± 5% or ± 10 L/min (meets ISO 23747) |
| Repeatability (PEF) | ISO 23747:2015 | ±5% or ± 10 L/min (meets ISO 23747) |
| Linearity (PEF) | ISO 23747:2015 | ±5 % (meets ISO 23747) |
| Resistance to flow (PEF) | ISO 23747:2015 | under 0.36 kPa/l/s (0.006 kPa/l/min) (meets ISO 23747) |
| Frequency response (PEF) | ISO 23747:2015 | 15 l/min (0,25 l/s), or 12 % (meets ISO 23747) |
| Shelf-Life | Device functionality, accuracy, and repeatability meet acceptance criteria after exposure to extreme conditions for 3 years. | Attributes met acceptance criteria after simulation of 3 years shelf life. |
| Electrical Safety | Compliance with ANSI/AAMI 60601-1:2005//(R)2012 &A1:2012, IEC 60601-1-6:2010, and IEC 60601-1-11:2015 | Demonstrated compliance (leveraged from reference device). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 and Federal Communication Commission (FCC) Regulations Part 15B | Demonstrated compliance (leveraged from reference device). |
| Biocompatibility | Patient contacting materials are identical to reference device, and biocompatibility testing supports substantial equivalence. | Demonstrated compliance (leveraged from reference device). |
| Software Verification and Validation | Adherence to IEC 62304 and "Guidance for the Content of Premarket Submissions for Software in Medical Devices" (basic documentation level). | Results of executed protocols met acceptance criteria. |
| Cybersecurity | Compliance with FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." | Risk assessment performed, appropriate risk mitigation controls implemented and tested. |
| Reprocessing Evaluation | Meet cleaning and disinfection efficacy requirements in accordance with AAMI ST98, TIR12, and TIR30. | Demonstrated compliance (leveraged from reference device), no additional testing required due to no changes in hardware/materials. |
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.
Ask a specific question about this device
Page 1 of 1