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Ablation of skin for collecting capillary blood samples for subsequent analysis.
The Cell Robotic's Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals 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 document is a 510(k) summary for the Cell Robotics' Clinical Lasette P-200 Laser Skin Perforator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical performance data or detailed acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested details, particularly those related to acceptance criteria, sample sizes, ground truth establishment, expert involvement, and AI-specific studies (MRMC, standalone), are not applicable to this submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: In a 510(k) for a device like this, the primary "acceptance criterion" is demonstrating that the new device is substantially equivalent to a legally marketed predicate device in terms of intended use, indications for use, technological characteristics, and safety and effectiveness. The summary explicitly states: "The Cell Robotic's Clinical Lasette P-200 Laser Skin Perforator is substantially equivalent to the predicate device."

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

• Sample Size for Test Set: Not applicable. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no new clinical or nonclinical studies were conducted to generate a test set for this 510(k) submission.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable.

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

• Not applicable. No test set was described, and therefore, no expert-established ground truth for a test set was created for this submission.

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

• Not applicable. No test set was 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. This device is a laser skin perforator, not an AI/algorithm-based diagnostic or assistive system.

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

• Not applicable. This device is a laser skin perforator, not an AI/algorithm-based system.

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

• Not applicable. No ground truth in the context of diagnostic accuracy was established for this submission. The comparison is to "commonly used stainless steel blood lancets" based on the physiological outcome of creating a comparable perforation.

8. The sample size for the training set:

• Not applicable. This device is not an AI/algorithm that requires a training set.

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

• Not applicable. This device is not an AI/algorithm that requires a training set.

Summary of Study (Based on 510(k) Content):

• Study Type: This is a 510(k) Premarket Notification submission, which is not a "study" in the traditional sense of generating new clinical or performance data for the device. Instead, it's a regulatory process to demonstrate substantial equivalence to a legally marketed predicate device.
• Proof of Meeting Acceptance Criteria: The "proof" is the claim of "substantial equivalence" to the predicate device (Cell Robotics, Inc. Lasette Plus). The FDA's letter (K033799) confirms that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications.
• Rationale for Substantial Equivalence: The summary indicates the device's functional description (portable, battery-operated, single pulse laser, ablates a small hole comparable to blood lancets) and its intended use/indications (ablation of skin for capillary blood sampling) are equivalent to the predicate. The absence of new nonclinical or clinical performance data implies that the manufacturer relied on the established safety and effectiveness of the predicate device and the new device's similar technological characteristics and performance claims.

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The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.

The Cell Robotics Ultra-Light Laser System is an Er: Y AG laser producing emission at a wavelength of 2940nm. The laser consists of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the handpiece, which houses the laser.

This 510(k) summary for the Cell Robotics Ultra-Light Laser System states "Nonclinical Performance Data: None Required" and "Clinical Performance Data: None Required". Therefore, a study proving the device meets acceptance criteria was not part of this submission, nor were acceptance criteria explicitly defined in terms of device performance metrics.

The FDA's decision to clear the device was based on a finding of substantial equivalence to legally marketed predicate devices, rather than on new performance data demonstrating its adherence to specific acceptance criteria.

Therefore, most of the information requested in your prompt cannot be provided from the given document, as no performance study was conducted or submitted:

Here's what can be inferred or explicitly stated based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices.
• Reported Device Performance: No specific performance data (e.g., accuracy, precision) was reported or required for this 510(k) submission.

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

• Not applicable, as no performance study was conducted.

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 applicable, as no performance study was conducted.

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

• Not applicable, as no performance study was conducted.

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. This device is a laser system, not an AI diagnostic tool, and no clinical performance studies were required or submitted.

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

• Not applicable. This device is a laser system.

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

• Not applicable, as no performance study was conducted.

8. The sample size for the training set:

• Not applicable, as no performance study was conducted.

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

• Not applicable, as no performance study was conducted.

Summary from the document:

The Cell Robotics Ultra-Light Laser System was cleared based on its substantial equivalence to three legally marketed predicate devices:

• Schwartz Electro-Optics TriLase2940, K# 954013
• Cell Robotics Er: YAG Laser System, K# 970461
• Asceplion-Meditec Dermastar Er: YAG Laser System, K#014057

The FDA determined that "Nonclinical Performance Data: None Required" and "Clinical Performance Data: None Required" for this submission, indicating that the device's technological characteristics and intended use were sufficiently similar to the predicates that new performance studies were not deemed necessary to establish safety and effectiveness.

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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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The Cell Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.

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 Robotics' Lasette Laser Skin Perforator states that no acceptance criteria are explicitly defined within this document. The summary only mentions that two human clinical trials were conducted, and their results "indicate that the device is safe and effective." However, it does not provide specific performance metrics or thresholds for what constitutes "safe" or "effective."

Therefore, much of the requested information cannot be extracted directly from this document.

Here's the information that can be extracted, and where the document is lacking:

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 for test set: Not specified. The document only mentions "two human clinical trials."
• Data provenance: Not specified (e.g., country of origin). The trials were "human clinical trials relating to use in an at-home setting." It implies prospective data collection, but this 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 applicable/Not specified. The device is a physical tool for obtaining blood samples. Ground truth in this context would likely relate to the quantity and quality of blood samples obtained and patient experience (e.g., pain, ease of use), rather than expert interpretation of images or data. No information about experts establishing ground truth is provided.

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

• Not applicable/Not specified. Adjudication methods are typically relevant for studies involving subjective interpretations (e.g., image reading by multiple experts). This document describes performance in obtaining capillary blood samples, which would involve objective measurements and patient feedback.

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. This device is a laser skin perforator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI is irrelevant.

6. 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. Its performance is always with human interaction (the user applying the device).

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

• Not explicitly stated. Given the device's function, ground truth would likely involve:
  • Successful blood sample acquisition: Was enough blood obtained for analysis?
  • Pain assessment: Patient-reported pain levels compared to traditional lancets.
  • Ease of use: User feedback.
  • Safety outcomes: Adverse events (e.g., skin reactions, infections, though none are mentioned).
• The summary states "Results from the clinical trials indicate that the device is safe and effective," implying these types of outcomes were measured.

8. The sample size for the training set

• Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical device, not an AI system.

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

• Not applicable for the same reason as point 8.

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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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The Cell Robotics, Inc. unnamed Er: YAG Surgical laser is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision / excision), vaporizing and coagulation of soft tissues, including skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

The Cell Robotics Er:YAG Surgical Laser is an Er:YAG laser producing laser emission at 2940nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the swing arm and the handpiece, which houses the laser.

The provided text is a 510(k) summary for the Cell Robotics Er:YAG Pulsed Surgical Laser System. It focuses on establishing substantial equivalence to a predicate device and does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or the methodology of such a study.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

   • Not applicable / Not provided. The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None". The basis for clearance is substantial equivalence to a predicate device, not performance against specific acceptance criteria presented in a study within this document.

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

   • Not applicable / Not provided. No test set or performance data is mentioned.

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 applicable / Not provided. No ground truth or expert involvement for test data is mentioned.

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

   • Not applicable / Not provided. No adjudication method for test data is mentioned.

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 / Not provided. This device is a surgical laser, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

   • Not applicable / Not provided. This is a physical surgical device, not an algorithm.

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

   • Not applicable / Not provided. No ground truth data is mentioned or used for device performance assessment in this submission. The "ground truth" for regulatory clearance is the substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

   • Not applicable / Not provided. There is no indication of a training set as this is not a machine learning device, nor is a study involving performance data mentioned.

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

   • Not applicable / Not provided. No training set is mentioned.

Summary based on the document:

The Cell Robotics Er:YAG Pulsed Surgical Laser System was cleared based on its substantial equivalence to a predicate device, the Schwartz Electro-Optics TriLase2940 (K954013). The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, the document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any associated data regarding sample sizes, ground truth, or expert involvement.

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