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510(k) Data Aggregation
(143 days)
Genteel, LLC
The Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood.
The Genteel lancing device is for Single Patient Use Only.
The Genteel® Lancing Device (Genteel) is a dual-spring mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The Genteel lancing device is used with commercially available, sterile, standard square shaft blood lancets.
The provided document is a 510(k) summary for the Genteel Lancing Device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically seen for novel medical devices or AI algorithms.
Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
Below is a response based only on the information available in the provided text, indicating when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Puncture Capability: Demonstrates adequate depth and functionality for drawing capillary blood from fingertip or alternate sites. | Penetration Capability Protocol: "Performance testing includes a Penetration Capability protocol that demonstrates substantial equivalence." (Exact metrics/thresholds of penetration capability are not specified in this document.) |
| Material Safety & Biocompatibility: Materials are medical grade and suitable for patient contact. | "Genteel and the predicate devices are primarily made from different plastics which are both medical grade..." |
| Sterility: Disposable lancets used with the device are sterile. | "The Genteel lancing device is used with disposable sterile lancets..." |
| Single Patient Use: Device designed and labeled for single patient use. | "The Genteel lancing device is for Single Patient Use Only." |
| Substantial Equivalence: Device performs as intended, similarly to legally marketed predicate devices, for collecting capillary blood. | "The Genteel Lancing Device... is substantially equivalent to the chosen predicate devices, the On Call® Chosen Lancing Device (K113332) and the Autolet Impression Lancing Device..." "The Genteel 510(k) documents and results of the non-clinical testing demonstrate that Genteel is substantially equivalent..." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. The document refers to "Performance testing includes a Penetration Capability protocol," but the sample size for this protocol is not provided.
- Data Provenance: Not specified. This would typically be part of a detailed study report, which is not included here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. This type of information would be relevant for devices demonstrating diagnostic accuracy against an expert-derived ground truth (e.g., imaging devices analyzed by radiologists). The Genteel Lancing Device is a mechanical lancing device, and its performance is evaluated based on physical characteristics and functional tests (like penetration capability) rather than expert interpretation.
4. Adjudication method for the test set
- Not Applicable / Not Provided. Adjudication methods are typically used in studies where multiple human readers or systems interpret data, and their disagreements need to be resolved to establish a definitive ground truth. This is not relevant for the type of device and performance evaluation described.
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
- Not Applicable. The Genteel Lancing Device is a mechanical lancing device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. As the Genteel Lancing Device is a mechanical device, there is no "algorithm only" performance to evaluate. Its "standalone" performance would be its functional performance, which is covered by the "Penetration Capability protocol" mentioned as part of non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Functional Performance Standards: The "ground truth" for the Genteel Lancing Device's performance would be established functional standards and metrics (e.g., consistent penetration depth, proper blood sample collection) as determined by an engineering or performance testing protocol. The document states, "Performance testing includes a Penetration Capability protocol that demonstrates substantial equivalence." The specific parameters of this "ground truth" (e.g., minimum blood volume, specific depth range) are not detailed in this summary.
8. The sample size for the training set
- Not Applicable / Not Provided. The Genteel Lancing Device is a mechanical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant to the Genteel Lancing Device.
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