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The Disposable Safety Lancet is intended for capillary blood sampling.

The Disposable Safety Lancet is intended for capillary blood sampling. The Disposable Safety Lancet include eleven models as IV, V, W2, M3, M3 PLUS, M4, M5, M5 MINI, M6, M7, E1. The models include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G. Disposable Safety Lancet are spring-loaded lancet. Disposable Safety Lancet are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle.

The provided document is a 510(k) summary for a medical device called "Disposable Safety Lancet". It describes the device, its intended use, and argues for its substantial equivalence to a predicate device based on non-clinical tests.

However, the document does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in a way that typically applies to AI/ML medical devices.

Specifically, it lacks the following information that you requested:

• A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria (e.g., sensitivity, specificity, accuracy) for diagnosis or detection, nor does it present results against such criteria. The "performance" mentioned is in the context of mechanical and biocompatibility testing.
• Sample size used for the test set and the data provenance: No test set (in the context of clinical data for AI/ML) is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to clinical assessment is discussed.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no clinical test set mentioned.
• 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: The device is a physical medical lancet, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a physical lancet in this context.
• The sample size for the training set: Not applicable for a physical lancet.
• How the ground truth for the training set was established: Not applicable for a physical lancet.

The "studies" mentioned in the document are non-clinical bench tests and biocompatibility evaluations, not clinical performance studies involving a test set, ground truth acquisition, or expert readers.

Here's a summary of the non-clinical tests that were performed and their conclusions:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set Sample Size: Not applicable. The document refers to non-clinical bench tests and biological evaluations, not a clinical test set with patient data for performance evaluation.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for clinical diagnostic purposes or AI model validation is not relevant for this type of device and study.

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

• Not applicable.

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:

• No. This is a physical medical device (lancet), not an AI/ML diagnostic or assistive device.

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

• No. This is a physical medical device.

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

• Not applicable in the context of AI/ML evaluation. The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., cell viability for cytotoxicity, physical measurements for mechanical tests).

8. The sample size for the training set:

• Not applicable. This is a physical medical device.

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

• Not applicable.

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The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The proposed device, RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The RightLance Blood Lancing System is made up of Lancing Device and Disposable Lancet.

The Model of Lancing Device: RC-AD-III; RC-AD-IIIT; RC-AD-VIU; RC-AD-VIX; RC-AD-VIXT; RC-AD-VII; RC-AD-XI; RC-AD-XII; RC-AD-XIV; Sinodraw; RC-LD-16; RC-LD-17; RC-LD-18; RC-LD-19

The Model of Disposable Lancet: I Size: 21G, 23G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G

This is a 510(k) premarket notification for a medical device called the RightLance Blood Lancing System. The document focuses on establishing substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System, rather than providing a detailed study that proves the device meets specific acceptance criteria as one might find for an AI/ML powered device.

Therefore, many of the requested elements for AI/ML device studies (like effect size for MRMC studies, training set details, or complex ground truth establishment) are not applicable to this type of submission.

Here's an analysis based on the provided text, focusing on what is relevant for a non-AI medical device submission:

Acceptance Criteria and Device Performance

There isn't a table of quantitative performance acceptance criteria in the typical sense of measuring algorithm accuracy (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the comparison to the predicate device and compliance with recognized international standards and internal design specifications. The device is accepted if it performs "as well as or better than" the predicate device and meets its own design specifications.

The comparison table provided (page 4) details the technological characteristics, highlighting similarities and differences with the predicate.

Table of Acceptance Criteria (Implied by Predicate Comparison and Standards) and Reported Device Performance

Study Details (as applicable)

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

   • No "test set" in the context of an AI/ML algorithm evaluation.
   • For the non-clinical bench testing, the sample sizes are not specified in the provided summary.
   • Data provenance: Not applicable for this type of device where laboratory bench testing is the primary evidence.

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

   • Not applicable. There is no "ground truth" establishment by experts for this type of mechanical lancing device. The performance is assessed against engineering specifications and international standards.

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

   • Not applicable. No expert adjudication process is described or relevant for this device.

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. This is not an AI/ML powered device, so MRMC studies are not relevant.

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

   • Not applicable. This is a manual mechanical device, not an algorithm. The non-clinical tests assess the device's physical and functional performance directly.

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

   • For this device, "ground truth" would be defined by engineering specifications, international standards (e.g., ISO, USP), and the performance characteristics of the predicate device. For example, a "puncture depth" test would have an expected range based on design, and the device's output would be measured against that.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

   • Not applicable. No training set.

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