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The L1 System is an automatic blood lancet device used to obtain a capillary blood sample.

Handheld, battery powered electronic lancing system for home use by individuals and caregivers to obtain blood samples.

The provided text is a 510(k) summary for the Pelikan Technologies L1 System, a blood lancet device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria or a dedicated study proving device performance against those criteria.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not specified. The document mentions "testing performed" but does not provide any details about the sample size (number of devices tested, number of subjects/uses) or the provenance (e.g., country of origin, retrospective/prospective nature) of the data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable/Not specified. For a blood lancet, the "ground truth" typically relates to objective physical performance (e.g., successfully obtaining a blood sample, depth of penetration, pain level reported by subjects). There is no mention of experts being used to establish a subjective "ground truth" in the way one might for diagnostic imaging.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. As there's no mention of a diagnostic interpretation or subjective assessment necessitating adjudication, this information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiology scans for AI assistance). The L1 System is a mechanical device for blood collection, not a diagnostic interpretation tool, so an MRMC study would not be applicable.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. The L1 System is a physical device, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

• Implied objective physical performance measures. While not explicitly stated, for a blood lancet, the ground truth would likely be objective measurements related to its function: successful blood sample collection, consistency of lancing depth, device reliability, and possibly subjective user feedback on pain or ease of use. The document refers to "specifications" and "performance standards," which would embed these ground truths.

8. Sample Size for the Training Set:

• Not applicable/Not specified. The L1 System is a mechanical device, not one based on machine learning or AI that requires a "training set."

9. How Ground Truth for the Training Set Was Established:

• Not applicable. As no training set is mentioned or implied, this question is not relevant.

Summary of Missing Information:

The provided 510(k) summary is very high-level and, as is common for many non-AI/non-diagnostic devices, does not include the detailed performance study methodology and results typically associated with modern medical device clearances, especially those involving AI or complex diagnostic interpretations. The document only generically states that "Testing performed under the Design Control Process verified that the L1 System performed according to specifications and is in compliance with all applicable performance standards." It lacks:

• Specific, quantifiable acceptance criteria.
• Details of any performance study (e.g., sample size, study design, actual results).
• Information about the "applicable performance standards" or "specifications" it met.

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