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Ablation of skin tissue to establish capillary blood access. The Cell Robotics Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood glucose concentration and hematocrit.

The Cell Robotics Laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.

This 510(k) summary for the Cell Robotics Lasette Laser Skin Perforator does not explicitly define specific quantitative acceptance criteria or provide a detailed study report with performance metrics against those criteria. Instead, it states that three human clinical trials were conducted, and their "Results from the clinical trials indicate that the device is safe and effective." The conclusion then asserts "The Cell Robotic's Lasette Laser Skin Perforator is substantially equivalent to the predicate devices."

Therefore, I cannot populate the table with specific numerical acceptance criteria and reported device performance from this document. However, I can infer the general purpose of the studies and extract other requested information.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified in this summary.
   • Data Provenance: "three human clinical trials" were conducted. The summary implies these are prospective human trials, and given the applicant's address in New Mexico, USA, it's highly likely the data is from the United States.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not specified in this summary. The ground truth would likely be the standard methods for determining blood glucose concentration and hematocrit from the collected blood samples, compared against established laboratory measurements from traditional methods.

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

   • Not specified in this summary.

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

   • Not applicable. This is a medical device for blood sampling, not an AI-assisted diagnostic imaging device that involves human readers interpreting results.

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

   • Not applicable. This is a physical device, not an algorithm. The "standalone" performance would be the device's ability to, independently, create a perforation and allow blood collection. The summary indicates it does this effectively.

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

   • The ground truth would be based on the accuracy of blood glucose concentration and hematocrit measurements obtained from the blood samples collected by the device, likely compared to measurements from blood samples collected via a predicate device or conventional venipuncture methods. This would involve laboratory testing and clinical outcomes related to the quality of the sample for diagnostic purposes.

7. The sample size for the training set

   • Not applicable. As a physical device rather than a machine learning algorithm, there is no "training set" in the conventional AI sense. The development and testing would involve engineering and clinical validation rather than algorithmic training.

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

   • Not applicable for the same reasons as above.

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The Cell Robotics Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from all patients (5 years old and above) for subsequent determination of blood glucose concentration and hematocrit.

The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.

Here's an analysis of the provided text regarding the Cell Robotic's Lasette Laser Skin Perforator, focusing on acceptance criteria and study details:

Missing Information: It's important to note that the provided 510(k) summary and FDA letter do not contain specific details about acceptance criteria, device performance metrics, or any clinical study results. The document explicitly states "Nonclinical Performance Data: None" in the summary. The FDA letter confirms substantial equivalence but does not describe the data supporting that equivalence.

Therefore, many of the requested details cannot be extracted from the provided text.

Acceptance Criteria and Device Performance (Based on Inferred Information)

Since no specific performance data or acceptance criteria are provided, we can only infer the type of acceptance criteria that would likely be relevant for a device like this based on its intended use and predicate devices (steel lancets).

Inferred Acceptance Criteria Table

Notes on Inferred Criteria:

• Given the device's purpose is "ablation of skin tissue to establish capillary blood access" for glucose and hematocrit determination, key performance metrics would revolve around the quality and quantity of the blood sample, patient comfort, and safety.
• The comparison to "commonly used stainless steel blood lancets" strongly implies that the Lasette needed to demonstrate performance at least equivalent to these predicate devices.

Study Details (Based on Provided Text – Primarily "None" or Not Applicable)

As stated above, no study data or methodologies are detailed in the provided 510(k) summary.

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

   • Test Set Sample Size: Not provided.
   • Data Provenance: Not provided (likely domestic, given the US applicant and FDA submission, but no specifics). The document explicitly states "Nonclinical Performance Data: None," implying no formal test set data was submitted in this section.

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

   • Not applicable. No test set or ground truth establishment details are provided.

3. Adjudication method for the test set:

   • Not applicable. No test set or adjudication method details are provided.

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:

   • Not applicable. This device is a laser skin perforator, not an AI diagnostic tool. No MRMC study would be relevant.

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

   • Not applicable. This is a medical device for blood sampling, not an algorithm.

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

   • Not applicable. No ground truth is described as no performance data is detailed. For a device like this, relevant "ground truth" might involve successful blood collection determined by laboratory analysis (e.g., sufficient blood volume, accuracy of subsequent glucose/hematocrit readings) or patient feedback on pain.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

   • Not applicable. See point 7.

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