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1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 10 °s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.

The provided text is a 510(k) Summary of Safety and Effectiveness for the WaveLight SINON laser system. It describes the device, its indications for use, and a comparison to predicate devices, but it explicitly states that no performance data is presented. Therefore, I cannot extract the requested information to describe acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:
"6. Performance Data
None presented."

This means that the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Information on experts or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone performance data.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The SINON SN-L402 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

The provided text describes a 510(k) premarket notification for a medical device (SINON SN-L402 Lightweight Wheelchair). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on specific performance metrics or clinical outcomes.

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable because the document does not present a clinical or performance study of the type that would involve these elements.

Here's the information that can be extracted from the provided text based on your prompt:

1. Table of acceptance criteria and the reported device performance

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

• Not applicable / Not provided. The document states that the device "meets the applicable performance requirements" of standards but does not detail a specific test set or clinical study with patient samples. The testing appears to be primarily engineering/product performance testing against established standards.

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

• Not applicable / Not provided. Ground truth, in the context of clinical studies, is not referenced as this is a device performance and substantial equivalence submission.

4. Adjudication method for the test set

• Not applicable / Not provided.

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 mechanical wheelchair, not an AI-assisted diagnostic or imaging device.

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

• Not applicable. This device is a mechanical wheelchair, not an algorithm.

7. The type of ground truth used

• For product performance: Compliance with ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards served as the basis for evaluating performance. In mechanical testing, the "ground truth" is often defined by the pass/fail criteria set forth by these recognized industry standards.
• For substantial equivalence: The predicate device (BIOTECH B900 SUPER LIGHT Wheelchair, K020472) served as the basis for comparison.

8. The sample size for the training set

• Not applicable / Not provided. No "training set" in the context of an algorithm or machine learning is mentioned.

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

• Not applicable / Not provided.

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1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 103s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.

The provided document, K040433 for the WaveLight Laser Technologie, AG SINON laser system, does not contain information about acceptance criteria or a study proving the device meets them.

The document explicitly states "Performance Data None presented." in section 6. This means there are no details available within this submission regarding:

• Specific acceptance criteria for device performance.
• Any studies conducted to demonstrate the device meets such criteria.
• Sample sizes for test sets or their provenance.
• Information about experts, ground truth, or adjudication methods for any hypothetical test sets.
• Any multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details or how their ground truth was established.

This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices based on device description and intended use, rather than presenting detailed performance study data.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The SINON Power Wheelchair, SN-P401 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of medical efficacy or diagnostic performance. Instead, it details a 510(k) premarket notification for a powered wheelchair, focusing on substantial equivalence to a predicate device.

The "Performance Testing" section mentions:

• EMC Report
• ANSI / RESNA WC/Vol.2-1998
• CISPR 11: 1990
• EN61000-3-2: 1995
• IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)

These are standards related to electromagnetic compatibility and general safety and performance for wheelchairs, not acceptance criteria for a diagnostic or AI-driven medical device. The document states that "electronic systems between two devices are the same and all passed by the UL." This implies compliance with safety standards rather than a clinical study evaluating performance metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.

However, based on the limited information related to "Performance Testing" and the nature of this submission (510(k) for a powered wheelchair), a hypothetical interpretation of "acceptance criteria" for a physical device would be compliance with recognized safety and performance standards.

Here's how I would attempt to answer based on the given context, with significant caveats that the document does not provide the detail usually associated with AI/diagnostic device studies:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. The document refers to engineering and safety standards compliance, not data sets for clinical or algorithmic performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of a powered wheelchair would be linked to engineering specifications and safety testing, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set: Not applicable.

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 is a physical device, not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For safety and performance standards, the "ground truth" would be the engineering specifications, test protocols, and pass/fail criteria defined by the listed standards (e.g., ANSI/RESNA, CISPR, IEC).

8. The sample size for the training set: Not applicable. This device does not use a training set in the AI sense.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (a powered wheelchair) through compliance with recognized safety and performance standards, rather than presenting a study evaluating diagnostic accuracy or AI performance against specific acceptance criteria.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The SINON Power Wheelchair, SN-W401 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text describes a 510(k) premarket notification for the SINON Power Wheelchair, SN-W401. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and their fulfillment in the way one might see for a diagnostic AI device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this type of regulatory submission for a powered wheelchair. The submission relies on established engineering standards and comparison to a legally marketed equivalent device, not a performance study as typically understood for AI/diagnostic tools.

Here's a breakdown of the information available and what is not applicable:

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

The "acceptance criteria" here are defined by compliance with established Electromechanical Compatibility (EMC) standards and safety certifications for powered wheelchairs. The document states that the device "passed" these.

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

• Not applicable in the context of this device. This is not a data-driven diagnostic device. Performance is assessed through engineering tests on the device itself.
• The "test set" would be the single device or a small sample of devices manufactured for testing against the engineering standards.

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

• Not applicable. Ground truth for a powered wheelchair involves meeting specific engineering and safety standards, not expert interpretation of diagnostic data. The "experts" would be the certified testing bodies (e.g., those issuing UL certification and conducting EMC tests).

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

• Not applicable. Performance against engineering standards is typically binary (pass/fail) or quantitative measurement against a threshold, not subjective adjudication.

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 is not an AI or diagnostic device that involves human readers.

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

• Not applicable. This is a hardware device (powered wheelchair), not an algorithm. Its "standalone" performance refers to its operational capabilities as a wheelchair, which are validated through compliance with the listed engineering standards.

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

• The "ground truth" for this device is defined by established international and national engineering standards for powered wheelchairs (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3) and safety certifications (UL certification).

8. The sample size for the training set

• Not applicable. This is not a machine learning or data-driven device.

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

• Not applicable.

Additional context from the document:

• Legally marketed device for substantial equivalence comparison: EPW Foldable Power Wheelchair EPW-03 (K033206)
• The basis for substantial equivalence is that the electronic systems (controller, batteries, recharge) are the "same and all passed by the UL certificated" as the predicate device, ensuring the "same safety level."
• Differences like battery type, overall dimensions, tire size, and weight are noted but deemed "not safety aspect" differences that would negate substantial equivalence.

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