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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.

Device Description

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

AI/ML Overview

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):

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Appearance	Functional Verification	Should meet the same intended use as the predicate device and not impact safety/effectiveness.	All test results met acceptance criteria, demonstrating that the different appearance design of the candidate device (TD-5010 Lancing Device) met the same intended use as the predicate device and did not impact safety and effectiveness.
Biocompatibility	Biocompatibility Tests (TD-5010 Lancing Device)	Housing materials should not affect biocompatibility.	Results demonstrated that the housing materials of TD-5010 Lancing Device would not affect biocompatibility.
Biocompatibility	Biocompatibility Tests (TD-5084 Sterile Lancets)	Materials should not affect biocompatibility.	Results demonstrated that the materials of TD-5084 Sterile Lancets would not affect biocompatibility.
Cleaning & Disinfection	Disinfection Validation Test	Housing materials should not affect the effectiveness of cleaning and disinfection.	Results demonstrated that the housing materials of TD-5010 Lancing Device would not affect the effectiveness of cleaning and disinfection.
Puncture Depth/Needle Length	Mechanical Performance Test	Puncture depths and exposed needle length within specifications. Similar range to predicate device.	Puncture depths and exposed needle length of candidate device met its specifications. The range was similar to the predicate device.
Firmness Force	Firmness Force Test (Aging Tests)	Needle firmly fixed in lancet housing. Within acceptance criteria in accelerated and real-time aging tests.	The firmness force was within acceptance criteria in the accelerated and real-time aging tests. The needle of TD-5084 Sterile Lancets was verified to be firmly fixed in the lancet housing at each time point.
Lancet Loading	Loading Force and Pulling Force Test	Lancets can be effectively and smoothly loaded by end users.	All test results of lancet loading force met the acceptance criteria, demonstrating that the safety and effectiveness of the loading mechanism (loading force and pulling force) of the candidate device was substantially equivalent to the predicate device. Lancets can be effectively and smoothly loaded by end users.
Needle Specification (30G vs 28G)	Percussion and Firmness Force Test	Puncture depths meet specifications. Needle firmly fixed in housing.	Puncture depths of both TD-5084 Sterile Lancets (30G) and predicate device (28G) met specifications. The needle of TD-5084 Sterile Lancets (30G) was firmly fixed in lancet housing at each time point of accelerated and real-time aging tests.
Lancet Cap Removal	Lancet Cap Twist Force and Pulling Force Test	Lancet cap can be easily and safely removed by end user.	All test results met acceptance criteria, demonstrating that the lancet cap of the candidate device can be removed by end user smoothly and safely.
Drop Testing	Drop Testing	Appearance and performance meet intended use after drop forces.	All test results met acceptance criteria, demonstrating that lancing devices installed with lancets met its intended use after undergoing drop forces during operations. Appearance and performance verified after drop forces.
Storage Stability	Storage Stability Test	Safety and effectiveness suitable for use over the claimed shelf life.	Performed to ensure the safety and effectiveness were suitable for use over the shelf life of the device. (Implied: met acceptance criteria, as the conclusion states the device has a substantially equivalent safety and effectiveness profile).
Robustness	Robustness Test (Cleaning/Disinfection)	Device robust against multiple cleaning and disinfection cycles.	Demonstrated that the TD-5010 Lancing Device was robust against cleaning and disinfection procedures after multiple cleaning and disinfection cycles using EPA-registered disinfecting wipes. (Implied: met acceptance criteria, as the conclusion states the device has a substantially equivalent safety and effectiveness profile).

Study Details:

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.
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.
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.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No AI algorithm.
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).
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.
How the ground truth for the training set was established:
- Not applicable.

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