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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 TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.

For use only on a single patient in a home setting.

Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:

(1)TD-5010 Lancing Device

(2) Alternative Site Testing (AST) Cap

The provided text describes the submission for a medical device (TD-5010 Lancing Device and TD-5084 Sterile Lancets) for clearance by the FDA, based on substantial equivalence to a predicate device (Accu-Chek Softclix Blood Lancing System). The document focuses on non-clinical performance testing rather than a clinical study involving human patients or an AI algorithm.

Therefore, many of the requested fields regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and statistical measures for an AI/ML-based medical device are not applicable to this submission as it pertains to a mechanical lancing device and sterile lancets. There is no AI or software component described in this submission.

However, I can extract the acceptance criteria and performance data for the mechanical and material properties of the lancing device and lancets as described in the non-clinical testing summary.

Here's the breakdown based on the provided document:

Device: TD-5010 Lancing Device and TD-5084 Sterile Lancets

Study Type: Non-clinical (bench) performance testing for substantial equivalence. This is not a study proving the efficacy of an AI model.

Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing):

Study Details:

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

   • The document describes bench testing of physical devices and components, not a "test set" in the context of an AI/ML algorithm.
   • Specific numbers of devices or lancets tested for each non-clinical test (e.g., how many lancet caps twisted, how many devices dropped) are not explicitly stated. The provenance is implied to be laboratory testing conducted by the manufacturer. It is non-clinical/bench data.

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

   • Not applicable. This is a mechanical device, not an AI model requiring expert ground truth for image interpretation or diagnosis. Ground truth is based on engineering specifications and physical measurements.

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

   • Not applicable. There's no human interpretation or adjudication process described for the device's mechanical performance.

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. No AI component. No human reader study described.

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

   • Not applicable. No AI algorithm.

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

   • For the non-clinical tests, the "ground truth" or reference standards are the engineering specifications, physical measurements, and established testing protocols (e.g., for sterilization, biocompatibility, mechanical forces, and material properties) for lancing devices, often guided by relevant ISO standards (though not explicitly cited for each test, 21 CFR 878.4850 is mentioned).

7. The sample size for the training set:

   • Not applicable. There is no AI component and thus no "training set" in the context of machine learning.

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

   • Not applicable.

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