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FOX 810:
Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, and pulmonology.

FOX 980:
Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, pulmonology, and thoracic surgery.

The FOX Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode, the laser system can radiate one factory set wavelength with either 810nm or 980mm. The FOX is a compact diode laser with a high-resolution color touchscreen for user control.

This document is a 510(k) Premarket Notification from the FDA for the FOX 810 and FOX 980 Diode Laser Systems. It establishes substantial equivalence to predicate devices for surgical applications involving soft tissue. There is no information regarding AI/ML in this document. Therefore, I will answer the questions based on the provided text, primarily focusing on general device performance criteria where applicable.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device (e.g., incision depth, coagulation time) that were then "reported" as meeting those criteria. Instead, it details that the device has been tested against various IEC and EN standards to ensure safety and essential performance, and it performs comparably to its predicate devices in terms of power output and tissue interaction mechanisms.

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The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm.

The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.

The provided document describes the FDA 510(k) summary for the "Wolf 445nm" diode laser system. This device is a laser surgical instrument, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices, not on proving new clinical effectiveness or diagnostic accuracy through AI performance studies.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and AI-specific metrics are not applicable to this type of regulatory submission. This document describes a medical device, but it is not an AI/ML medical device.

However, I can extract the information that is relevant to the device's performance demonstration.

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

For this type of device (a surgical laser), acceptance criteria are primarily related to safety and performance characteristics in comparison to established predicate devices. The "reported device performance" is demonstrated through non-clinical bench testing.

2. Sample sized 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 explicitly stated in terms of number of tissue samples or specific test parameters. The document mentions "histological samples" were evaluated but does not provide details on the quantity. This was a bench test, not a clinical study involving human patients.
• Data Provenance: The testing was "non-clinical" and involved "histological samples." No country of origin for the biological samples is provided. Given the manufacturer is German, it is likely the testing was conducted in Germany or a contracted lab. The testing is presumed prospective as part of the device development and submission process.

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)

• The document does not specify the number or qualifications of experts who evaluated the histological samples. This is common for non-clinical bench testing where expert histological analysis is implied rather than formalized as a "ground truth" establishment for a clinical accuracy claim.

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

• Not applicable/Not described. The non-clinical bench testing involved evaluating histological samples; there's no indication of a multi-reader or adjudication process as would be seen in a diagnostic imaging study.

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 MRMC study was done. This is a laser surgical instrument, not an AI-powered diagnostic tool. The submission is for substantial equivalence to predicates for soft tissue applications.

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

• Not applicable. This device is a physical laser system, not an algorithm.

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

• For the non-clinical tissue interaction testing, the "ground truth" was established by histological evaluation of "areas of visible alteration of depth and width of the incision as well as zones of thermal and mechanical damage." This represents a form of pathology/histology-based assessment.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

• Not applicable. As there is no training set mentioned, this question does not apply.

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The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.

The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.

The provided text is a 510(k) summary for the Cetus System, a laser system for phacofragmentation of cataractous crystalline lenses. It focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and non-clinical performance data.

However, the document does not contain information related to acceptance criteria, clinical studies, or performance metrics in the way your prompt describes for AI/medical device performance evaluation. Such information would typically include:

• Acceptance Criteria for Device Performance: Specific numerical thresholds for metrics like accuracy, sensitivity, specificity, etc.
• Reported Device Performance: Actual results from tests against these criteria.
• Sample Sizes, Data Provenance, Ground Truth: For clinical or simulated clinical studies demonstrating performance.
• Expert Review/Adjudication: Details on how ground truth was established, especially in diagnostic/imaging devices.
• MRMC or Standalone Studies: Type of clinical efficacy study.

Therefore, based solely on the provided text, I cannot complete the table or answer the questions related to clinical performance, acceptance criteria, or studies proving the device meets them because this information is not present.

The document explicitly states: "Clinical Performance Data: None".

The "performance data" referred to in the document is non-clinical and focuses on compliance with various safety, sterilization, packaging, and risk management standards, rather than the device's clinical efficacy or output performance as measured by typical diagnostic/treatment metrics.

Here's what I can extract from the provided text relevant to the device and its testing, but it does not address your specific request for acceptance criteria and clinical performance study details:

1. Table of Acceptance Criteria and Reported Device Performance:

• None provided for clinical performance. The document only lists non-clinical compliance standards.

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

• Not applicable / Not provided. No clinical test set.

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

• Not applicable / Not provided. No clinical test set.

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

• Not applicable / Not provided. No clinical test set.

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. The document explicitly states "Clinical Performance Data: None." This device is a surgical tool, not an AI diagnostic tool, so an MRMC study is not relevant in the context of this submission.

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

• No. The document explicitly states "Clinical Performance Data: None."

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

• Not applicable / Not provided. No clinical test set.

8. The sample size for the training set:

• Not applicable / Not provided. No training set for an AI algorithm is mentioned as this is a physical medical device.

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

• Not applicable / Not provided. No training set for an AI algorithm is mentioned.

Summary of Non-Clinical Performance Data from the document:

The device's safety and effectiveness were demonstrated through compliance with various non-clinical standards:

• Electrical Safety: AAMI ANSI ES60601-1:2005(R) 2012 and A1:2012
• Laser Safety: IEC 60825-1:2007
• Electromagnetic Compatibility: IEC 60601-1-2:2007
• Sterilization: DIN EN ISO 11135-1:2014
• Packaging Integrity: ASTM F1886/ F1886M-09:2013
• Accelerated Ageing of Sterile Barrier: ASTM F1980-07:2011
• Sterile Packaging: DIN EN 868-5:2009
• Microbial Ranking of Porous Packaging Materials: ASTM F1608-00:2009
• Biological Evaluation of EO Residuals: DIN ISO 10993-7:2009
• Risk Management: ISO 14971: 2007 + Am 2010

The document concludes based on these non-clinical tests that the Cetus system is "as safe and effective as the predicate device."

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The A.R.C laser surgery fibers and probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue.

The A.R.C. Laser Surgery Fibers & Probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

The A.R.C. surgical laser fibers & probes are single use laser delivery devices provided EO sterile and intended for medical applications in various fields of laser surgery. The devices are based on a quartz core, have a length of 6.5 feet (2 meters) to 9.9 feet (3 meters) and a wavelength range between 450nm to 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue in pulsed and continuous wave mode. The distal end have a bare tip which may be flat or spherical, and may be used with a variety of sterile hand pieces for the various intended uses and effects.

The provided document is a 510(k) premarket notification for the A.R.C. Laser Surgical Fibers & Probes. It describes the device's intended use and claims substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria for a device performance study or the details of such a study as typically required for AI/ML medical devices.

The document details performance bench testing for the physical characteristics of the fibers and their packaging/sterilization, but not a study of clinical performance or algorithm performance. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets them in the context of AI/ML.

Here's why I cannot fulfill your request based on the provided text:

• No AI/ML Component: The device described is a physical laser fiber and probe. There is no mention of an AI/ML algorithm or software component.
• No Performance Metrics like Sensitivity, Specificity, AUC: The "performance" section discusses bench tests related to the physical integrity, energy transmission, and sterility of the fibers. It does not mention clinical performance metrics that would be associated with an AI/ML diagnostic or prognostic device (e.g., sensitivity, specificity, accuracy, F1-score, AUC).
• No Clinical Study Details: The document explicitly states "Clinical Performance data: None." This means there was no clinical study conducted or submitted as part of this 510(k) to evaluate the device's performance in a clinical setting with human subjects.
• No Ground Truth Establishment: Since there isn't a clinical performance study involving diagnostic or prognostic outputs, there's no ground truth to be established by experts or pathology.

Summary of what can be extracted, demonstrating why the requested information for an AI/ML device is not present:

• Table of acceptance criteria and reported device performance: Not available for AI/ML performance. The document lists physical bench tests and standards/guidelines (e.g., ASTM F1886/F1886M-09: 2013 for packaging).
• Sample size used for the test set and data provenance: Not applicable. No test set for AI/ML.
• Number of experts used to establish the ground truth...: Not applicable. No ground truth for AI/ML.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Conclusion: The provided FDA 510(k) clearance letter and summary pertain to a physical medical device (laser fibers and probes) and do not include the type of information requested for evaluating an AI/ML medical device's performance or its associated studies.

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The Fox Q-980 Diode Laser is indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery and laser assisted lipolysis.

Fox Q-980 is a standard diode medical laser with 980nm wavelength and quartz fibers

This document describes a 510(k) submission for the Fox Q-980 Laser. The submission is primarily focused on demonstrating substantial equivalence to predicate devices, particularly for the added indication of laser-assisted lipolysis.

Here's an analysis of the provided text in relation to your questions:

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

Based on the provided text, there are no specific performance acceptance criteria or reported device performance metrics in the format of a clinical study or performance data table. The submission relies solely on demonstrating compliance with recognized standards and equivalence to predicate devices, rather than establishing de novo performance targets.

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. The document does not describe a clinical study with a test set.

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. The document does not describe a clinical study with ground truth established by experts.

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

Not applicable. The document does not describe a clinical study with an adjudication method.

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 surgical instrument, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance in a diagnostic capacity.

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

Not applicable. This device is a laser surgical instrument, not an algorithm.

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

Not applicable. The document does not describe a clinical study requiring ground truth. The primary ground for approval is substantial equivalence to legally marketed predicate devices and compliance with recognized performance standards. In this context, the "ground truth" for the device's safety and effectiveness is implicitly established by the predicate devices and their successful market history, as well as adherence to safety standards.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning algorithm or a training set.

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

Not applicable. The document does not describe a machine learning algorithm or a training set.

Summary of the 510(k) Submission for Fox Q-980 Laser:

This 510(k) submission for the Fox Q-980 Laser is a declaration of substantial equivalence to previously cleared devices (K073322 and K082721). The key arguments for equivalence are:

• Identical Core Device: The Fox Q-980 is stated to be the "same 980 nm laser cleared under K073322."
• Added Indication Equivalence: The added indication for laser-assisted lipolysis is justified by the fact that the predicate device LaserPro980 (K082721) also has this indication.
• Technological Characteristics: The device utilizes a 980nm diode laser and quartz fibers, similar to the predicate devices.
• Compliance with Standards: The device complies with relevant electrical and laser safety standards (21CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, IEC 60825-1) and sterilization standards (ISO 11135-1 and 2).

The 510(k) process for devices like this typically relies heavily on demonstrating that the new device does not raise new questions of safety or efficacy compared to legally marketed predicate devices, rather than presenting new clinical study data with specific acceptance criteria.

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Fox Q-810: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology.

Fox Q-980: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Fox Q-1064: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

Fox Q-810, Q-980 and Q-1064 are standard diode medical lasers with 810, 980nm and 1064nm wavelength, respectively

The provided text is related to a 510(k) summary for the Fox Q-810, Q-980, and Q-1064 Lasers. It outlines regulatory compliance and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, device performance from a study, sample sizes, expert involvement, or specific ground truth methods as would be found in a clinical or performance study report for an AI/ML medical device.

The document is a regulatory submission for a traditional medical device (diode laser) and focuses on demonstrating substantial equivalence to previously cleared devices and compliance with established performance standards (e.g., 21CFR 1040.10, IEC 60601-1). It deals with the inherent physical safety and performance of the laser itself, not an AI algorithm.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The device complies with "performance requirements of 21CFR 1040.10 and 1040.11, with permissible deviations defined in Laser Notice 50, dated July 26, 2001." It also complies with "IEC 60601-1:1998 including amendment 1, IEC 60601-2-22:1995, and IEC 60825-1:1993 including amendments 1 and 2." These are general safety and performance standards for lasers and medical electrical equipment, not specific criteria for an AI/ML algorithm's diagnostic or predictive performance.
• Reported Device Performance: The document states the device "generates energy in the 980 nm range" (and 810 nm, 1064 nm for other models) and "Fibers deliver energy to the tissue." It doesn't report specific performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcome statistics) that would necessitate an acceptance criterion table as requested for an AI/ML study. The "performance" here refers to meeting safety and output specifications according to the listed standards.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a study involving a test set of data for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving a test set of data for an AI/ML algorithm or ground truth established by experts in that context.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 device is a laser surgical instrument, 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. This device is a physical laser, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its physical specifications and safety compliance, not medical diagnostic outcomes.

8. The sample size for the training set: Not applicable. This device is a physical laser, not an AI algorithm requiring a training set.

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

Summary of available information from the document:

• 21CFR 1040.10 and 1040.11 (with deviations from Laser Notice 50, dated July 26, 2001)
• IEC 60601-1:1998 (including amendment 1)
• IEC 60601-2-22:1995
• IEC 60825-1:1993 (including amendments 1 and 2) |
  | Reported Device Performance | The device "uses diodes to generate energy in the [specified] nm range" (e.g., 980 nm, 810 nm, 1064 nm) and "Fibers deliver energy to the tissue." The performance is implied by its adherence to the above-listed standards, ensuring its safety and intended function as a medical laser. No specific quantitative performance metrics (e.g., accuracy, reliability in a clinical setting) are provided as would be for an AI/ML device. |
  | Study Type to Prove Acceptance | The document indicates a substantial equivalence (510(k)) review process, not a specific performance study in the context of AI/ML. The conclusion explicitly states: "The Fox 810, 980 and 1064 Lasers are substantially equivalent to the predicate devices. They have similar intended uses and comply with the same safety and performance standards." This implies that compliance with safety and performance standards was demonstrated through testing against those standards and comparison to predicate devices, rather than a clinical study evaluating diagnostic or predictive performance. |
  | Sample size (test set) | Not applicable. (No AI/ML test set) |
  | Data provenance (test set) | Not applicable. (No AI/ML test set) |
  | Number of experts for ground truth | Not applicable. (No AI/ML ground truth) |
  | Adjudication method | Not applicable. (No AI/ML test set) |
  | MRMC comparative effectiveness study | No. |
  | Standalone performance study | Not applicable. (No AI/ML algorithm) |
  | Type of ground truth used | For a laser, "ground truth" relates to its physical specifications, power output, wavelength accuracy, and safety features meeting established engineering and regulatory standards. Not expert consensus on medical images or patient outcomes in the context of performance study. |
  | Sample size (training set) | Not applicable. (No AI/ML training set) |
  | How ground truth for training set was established | Not applicable. (No AI/ML training set) |

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