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The Cell Robotic's Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.

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.

The provided 510(k) summary for the Cell Robotic's Lasette Laser Skin Perforator states that no nonclinical performance data was provided and that clinical performance data from three human clinical trials indicated the device is safe and effective. However, the summary does not provide specific acceptance criteria or detailed results from these trials. Therefore, much of the requested information cannot be extracted from the given text.

Here is a summary of what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: The document states "three human clinical trials under approved Investigational Device Exemptions." This implies the data is prospective and collected from human subjects, but the country of origin is not specified (though the company is US-based).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not specified. The document only mentions "clinical trials," but no details are provided regarding how ground truth was established, or if experts were involved in a review capacity for the test set.

4. Adjudication Method for the Test Set

• Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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-assisted diagnostic tool for human readers.

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

• Not applicable in the context of an algorithm. This is a physical device.

7. The Type of Ground Truth Used

• Not explicitly stated. Given the nature of a skin perforator for blood collection, ground truth would likely relate to efficacy of blood collection (e.g., successful blood draw, volume obtained) and safety (e.g., perforation depth, pain, infection rates). However, the document does not specify these metrics or how they were assessed.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would have a distinct "training set." The clinical trials would serve as the primary data for demonstrating safety and effectiveness. The sample size for these trials is not provided.

9. How the Ground Truth for the Training Set was Established

• Not applicable as there is no training set in the AI/ML context. For the clinical trials, the "ground truth" (i.e., objective measures of performance) would have been established through standard clinical assessment protocols, but these details are not provided in the summary.

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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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The Cell Robotics Lasette 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 using optically based measurement techniques.

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.

The provided text does not contain specific acceptance criteria or detailed results from the clinical studies. It merely states that "Results from the clinical trials indicate that the device is safe and effective." Therefore, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide detailed answers to most of the other questions.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

2. 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.
• Data Provenance: The text states the device was investigated in "two human clinical trials under approved Investigational Device Exemptions." This implies prospective data collection, likely within the United States given the FDA context, but the country of origin is not explicitly stated.

3. 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.

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

• Not specified.

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

• The device is a laser skin perforator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study is not applicable, and no effect size would be relevant in this context.

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

• This question is not applicable as the device is a physical medical device (laser skin perforator) and not an algorithm. Its performance is inherent to its mechanical and optical function.

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

• The purpose of the device is to "ablate skin tissue to establish capillary blood access" for collecting samples for glucose and hematocrit determination. The ground truth for safety and effectiveness would likely involve measures such as:
  • Successful blood collection rate: The ability to consistently obtain a sufficient capillary blood sample.
  • Pain assessment: Patient-reported pain levels compared to traditional lancets.
  • Ablation characteristics: Depth, diameter, and consistency of the perforation.
  • Healing time/side effects: Observation of the skin after perforation.
  • Blood sample quality: Comparison of blood glucose and hematocrit results with those obtained via venous draws or standard lancets.
  • The text does not specify which of these were used, only that the device was found "safe and effective."

8. The sample size for the training set

• Not applicable. The device is a hardware product, not a machine learning algorithm that requires a training set.

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

• Not applicable (as above).

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The Cell Robotics Lasette is intended for use for skin perforation and establishing capillary blood access for blood sampling. The Cell Robotics Lasette is indicated for use by qualified healthcare workers for perforation of the skin to draw capillary blood from healthy adult patients for subsequent determination of blood glucose concentration and hematocrit using colorimetric measurements.

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 a patient's fingertip comparable to that produced by commonly used stainless steel blood lancets. The complete Lasette product includes the Lasette. its labeling and manual, and single-use sanitary (non-sterile) plastic iqns shelds. The Lasette uses a small convection-cooled erbium: YAG solid state laser with a maximum output energy of 0.5 J per pulse at a wavelength of 2.94 micrometers and a pulse width of 300 microsconds. This energy is focused on a target spot with a diameter of 300 micrometers.

The provided text describes the "Lasette™ LASER SKIN PERFORATOR" and its 510(k) summary, but it primarily focuses on establishing substantial equivalence to existing devices and performance standards for laser products. It does not contain a detailed study with specific acceptance criteria and reported device performance in the format requested.

However, based on the information provided regarding the "Performance Data," I can infer and construct a response to the best of my ability, highlighting what is present and what is missing.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format, nor does it provide detailed numerical results for each criterion. It broadly states conclusions from the studies.

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

• Sample Size: Not explicitly stated for either the clinical human trial or the in vitro testing.
• Data Provenance:
  • Clinical Trial: A "human clinical trial" was directed toward determining the effect of use upon reliability of analytical results. The country of origin is not specified, but the applicant (Cell Robotics, Inc.) is based in Albuquerque, New Mexico, USA, suggesting a US-based study is likely. The text implies a prospective study since it was "directed toward determining."
  • In Vitro Testing: "Certain in vitro testing has been done to establish reliability of output energy calibration and depth of penetration." Details on specific provenance are not given.

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

• This information is not provided in the text. The concept of "experts" and "ground truth" in the context of reading clinical data (like blood glucose or hematocrit) is not discussed. The clinical trial focused on whether the device's use affected the reliability of subsequent measurements, implying the measurements themselves (glucose, hematocrit) were performed by standard laboratory methods, not interpreted by experts in the context of device performance.

4. Adjudication method for the test set:

• This information is not provided as the nature of the study (determining effect on analytical results and technical specifications) does not typically involve adjudication in the way image analysis or diagnostic studies might.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a laser skin perforator, not an AI-powered diagnostic or interpretive tool that human readers would use or improve with.

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

• This question is not applicable to the Lasette device as described. It is a physical medical device for blood sampling, not an algorithm or AI system.

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

• Clinical Trial: The "ground truth" implicitly refers to the accurate determination of blood glucose concentration and hematocrit using established colorimetric measurements. The study aimed to show that the Lasette's use did not alter these standard measurements.
• Technical Testing: For output energy, the ground truth would be a calibrated measurement of the laser's actual energy output. For penetration depth, it would be a physical measurement of the wound depth post-ablation.

8. The sample size for the training set:

• This information is not provided and is not applicable. The Lasette is a physical device, not an AI algorithm that requires a "training set."

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

• This information is not provided and is not applicable, as there is no "training set" for this type of device.

Summary of the Study:

The "Performance Data" section describes two main types of studies:

1. Human Clinical Trial:

   • Purpose: To determine if using the Lasette impacts the reliability of subsequent blood glucose and hematocrit measurements.
   • Finding: "Results of glucose and hematocrit determinations are not significantly affected by use of the device."
   • Missing Information: Sample size, details of study design, precise methodology, statistical significance levels, country of origin, and whether it was prospective/retrospective are not explicitly detailed beyond the general statement.

2. In Vitro Testing:

   • Purpose: To establish reliability of output energy calibration and depth of penetration.
   • Findings:
     • Output energy indicator is within 20% of the indicated value.
     • Penetration depth is approximately half of the depth predicted by a theoretical equation (d=H/F).
   • Missing Information: Sample size for these tests, specific methods used for calibration and depth measurement.

In conclusion, the document provides high-level summaries of performance data but lacks the granular detail of specific acceptance criteria and study methodologies often found in more comprehensive technical reports or clinical trial summaries. The focus of the 510(k) submission is on demonstrating "substantial equivalence" and adherence to laser safety standards rather than extensive clinical efficacy or detailed performance metrics against quantitative acceptance criteria for blood sampling.

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