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RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

GE Lancing Device is a reusable lancing device for the single used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.

RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device is a mechanical device holding and firing a single-use lancet linearly ahead to prick the skin to collect capillary whole blood from target sites. RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device can be adjusted for 7 levels of depth for a user collecting different amount of capillary blood.

This document describes the FDA's 510(k) clearance for the BIONIME Corporation's RIGHTEST Lancing Device GD500, GE Lancing Device, and iGlucose Lancing Device. It specifically focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device's performance against specific acceptance criteria for AI or diagnostic accuracy.

Therefore, many of the requested elements for an AI/diagnostic accuracy study (such as MRMC studies, effect size of human reader improvement with AI, specific ground truth methods, sample sizes for training/test sets related to AI model development, etc.) are not applicable to this document, as it pertains to a lancing device, not an AI-powered diagnostic tool.

However, I can extract the relevant information regarding the performance data and the basis for substantial equivalence for this medical device.

Device Under Review: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (reusable lancing devices for capillary blood sampling)

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

   Since this is a lancing device and not a diagnostic or AI device, the "acceptance criteria" here relate to safety, functionality, and biocompatibility, rather than diagnostic performance metrics like sensitivity/specificity. The document states that performance data demonstrated safety and efficacy but does not provide quantitative "acceptance criteria" for each test with reported values. Instead, it lists the types of tests performed.

   Acceptance Criteria (Implied by regulatory requirements for lancing devices)	Reported Device Performance (Summary from document)
   Biocompatibility (In vitro Cytotoxicity)	C. ISO 10993-5 In vitro Cytotoxicity A. was completed.
   Biocompatibility (Skin Irritation)	A. ISO 10993-23 Skin Irritation B. was completed.
   Biocompatibility (Skin Sensitization)	B. ISO 10993-10 Skin Sensitization (Maximization Test) was completed.
   Functional Performance	D. Functional tests were validated and completed.
   Cleaning and Disinfection Efficacy	E. The cleaning and disinfections on the materials of device were evaluated and tested.

   The document concludes that the device is "substantially equivalent to predicate devices in regard to indications for use, design, and technology, without raising any safety and efficacy risks or concerns," implying that the performance tests met the necessary standards for these types of devices.

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

   This information is not provided in the document as it's not a study on diagnostic accuracy or AI performance. The tests mentioned (biocompatibility, functional tests) would have their own sample sizes based on standard testing protocols for medical devices. The data provenance would be from laboratory testing.

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

   This is not applicable. Ground truth establishment by experts is relevant for diagnostic accuracy studies, especially for image interpretation. For a lancing device, "ground truth" would relate to measurable physical properties or biological responses (e.g., cytotoxicity, successful blood draw) determined by validated test methods, not expert consensus on images.

4. Adjudication method for the test set:

   This is not applicable as there is no expert adjudication process for the performance tests of a lancing device in this context.

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. This document is for a lancing device, not an AI-assisted diagnostic tool.

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

   This is not applicable. There is no AI algorithm in this device.

7. The type of ground truth used:

   For this type of device, the "ground truth" is defined by standardized laboratory test results for biocompatibility (e.g., cell viability assays, skin patch tests) and engineering validation for functional performance (e.g., consistency of lancing depth, successful lancet injection/retraction). It is not pathology or outcomes data in the sense of a diagnostic device.

8. The sample size for the training set:

   This is not applicable. This is not an AI/machine learning device that requires a training set.

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

   This is not applicable. No training set is used for this type of device.

Summary of Substantial Equivalence (as reported in the document):

The submission argues for substantial equivalence based on the following:

• Same "intended use/indication(s) for use": To obtain capillary blood samples for glucose monitoring or other tests requiring small amounts of blood, for single user, with depth adjustment and alternative site testing capabilities.
• Similar Technological Characteristics: Both the proposed and predicate devices are mechanical devices that hold and fire a single-use lancet linearly to prick the skin, automatically inject and retract the lancet, have a clear cap for alternative site testing, retract the lancet after use to prevent sharp injury, have mechanical loading and firing functions, and eject the used lancet without touching it.
• Differences noted: The primary difference is the "depth of penetration." The proposed device offers 7 different depths (0.5 mm to 1.7 mm) compared to the predicate devices' 6 different depths or interchangeable contact tips. The submission states this difference "did not raise other concerns on safety and efficacy."
• Performance Data: The provided performance data (biocompatibility and functional tests) demonstrated safety and efficacy consistent with the predicate devices and regulatory requirements.

The document concludes that the RIGHTEST Lancing Device GD500, GE Lancing Device, and iGlucose Lancing Device are "substantially equivalent to the predicate devices On Call Lancing Device and the Genteel Lancing Device (K113332 and K153670)."

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