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The Kogent Disposable Copper Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Copper Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue. The Kogent Disposable Copper Illuminating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and to supply light for surgical procedures.

These devices are disposable bipolar forceps, designed for single use in general surgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, irrigate and illuminate, when applicable, selected tissues. The irrigation tube is designed to carry sterile fluid to the tips of the instrument. The illumination style forceps contain illumination fibers on each tine to deliver light to the surgical site. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The forceps are provided sterile by ethylene oxide and in sterile pouches.

I am sorry, but based on the provided text, there is no information about a study that would include acceptance criteria and device performance in the context of an AI/human reader study or clinical trial as you've outlined.

The document is a 510(k) summary for medical devices (Kogent Disposable Copper Forceps, Irrigating, and Illuminating Bipolar Forceps), which focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing and adherence to recognized standards, rather than clinical efficacy trials involving human readers or AI.

Here's why none of your requested information can be extracted:

• No AI component: The devices described are electrosurgical forceps, not AI-powered diagnostic or assistive tools.
• No human reader component: The evaluation is for physical medical devices and their performance characteristics (e.g., sterilization, biocompatibility, electrical safety, thermal conductivity, non-stick ability), not for human interpretation of data.
• No clinical study: The document explicitly states, "Clinical Testing was not required to prove substantial equivalence." The evaluation is based on bench testing.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to AI or human interpretation.
2. Sample size for a test set in a human-in-the-loop or standalone AI study.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. MRMC study results or effect size for AI assistance.
6. Standalone AI performance.
7. Type of ground truth (expert consensus, pathology, outcomes data) for AI/diagnostic purposes.
8. Training set sample size (as there's no AI model to train).
9. How ground truth for a training set was established.

The provided document describes the following performance data and tests for the physical medical device:

• Medical Electrical Equipment Standards: IEC 60601-1 (various editions), IEC 60601-2-2, IEC 60601-1-6.
• Biocompatibility: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization), ISO 10993-11 (Systemic Toxicity).
• Sterilization: ISO 11135 (Ethylene oxide sterilization).
• Shelf Life: ASTM F1980 (Accelerated Aging).
• Bench Testing: Thermal Conductivity, Non-Stick Ability, Average Flow Rate (for irrigating forceps), Average Illumination Output (for illuminating forceps), Average Temperature Rise due to Illumination Output, Thermal Effects on Tissue.

These tests are designed to show that the new forceps are as safe and effective as existing legally marketed predicate devices, not to evaluate an AI or human interpretive performance.

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The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) is desired, including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, and Thoracoscopic Surgery.

The Kogent TorUS® consists of a console that provides power and control of the ultrasonic aspiration and irrigation functions, three surgical handpieces that provide the ultrasonic mechanical energy to the surgical site, a foot pedal to allow the user control over the ultrasonics, titanium tips (variety of models), irrigation sleeves, suction/irrigation system (manifold tubing and a vacuum canister) and accessories used for assembly and reprocessing. The Kogent TorUS accommodates most commercially available suction canisters and optional specimen traps.

The provided text describes the Kogent TorUS® Ultrasonic Aspirator System and asserts its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, reported device performance metrics in a quantitative table, or details of a study that directly prove the device meets such criteria.

Instead, the document highlights specific types of testing performed to demonstrate substantial equivalence, focusing on safety standards, biocompatibility, and general performance aspects relative to the predicate devices.

Let's break down what is and is not present based on your request:

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

• Not present. The document lists the types of bench testing performed (Thermal Effects, Suction and Aspiration Level, Surgical Bone Removal and Cutting, Soft and Fibrous Tissue Removal) but does not provide a table with "acceptance criteria" (e.g., "bone removal rate > X mm/sec") or "reported device performance" (e.g., "achieved Y mm/sec bone removal"). It states that the testing "indicates that the Kogent TorUS® Ultrasonic Aspirator System is substantially equivalent," implying the results met some unstated internal criteria for equivalence.

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

• Not present. The document mentions "bench testing" but does not specify the sample sizes used for any of the individual tests. It also does not explicitly state the "data provenance" (e.g., country of origin, retrospective/prospective). Given that it's bench testing, it would likely be laboratory data rather than patient data.

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

• Not present. This type of information is typically relevant for studies involving subjective human assessment (e.g., image interpretation, diagnostic accuracy). For a surgical aspiration device, "ground truth" would likely be established through objective physical measurements and comparisons to predicate device performance, not expert consensus on interpretations.

4. Adjudication method for the test set

• Not present. Similar to point 3, adjudication methods like "2+1" or "3+1" are used in studies where there's a need to resolve discrepancies in human interpretations or diagnoses. This is not applicable to the bench testing described for a surgical device's physical performance characteristics.

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 present. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems where human readers interact with the AI. This device is a surgical tool, and the documentation does not describe any AI component or human-in-the-loop diagnostic assistance for which an MRMC study would be appropriate. The focus is on the device's physical performance and safety.

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

• Not present. As mentioned above, there is no indication of an algorithm or AI component in this device. Therefore, a "standalone algorithm only" performance study is not applicable.

7. The type of ground truth used

• For the bench testing, the "ground truth" would implicitly be objective physical measurements and established engineering standards for performance characteristics (e.g., measuring actual aspiration rates, temperature changes, or material removal efficiency against specified targets or predicate device performance). The document does not explicitly state "ground truth" but implies comparison to predicate device performance.

8. The sample size for the training set

• Not applicable/Not present. Since there's no mention of an AI model or machine learning component, there would be no "training set" in the context of this device's evaluation.

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

• Not applicable/Not present. (See point 8).

Summary of available information related to performance evaluation, but not a direct answer to your table request:

The document states that Clinical Testing was not required and that "Bench testing" was performed to demonstrate substantial equivalence. The bench tests evaluated:

• Thermal Effects Testing at the Tip
• Suction and Aspiration Level Testing
• Surgical Bone Removal and Cutting Testing
• Soft and Fibrous Tissue Removal Testing

These tests were done to compare the Kogent TorUS® Ultrasonic Aspirator System to the predicate device (Stryker Sonopet iQ Ultrasonic Surgical Aspirator and Sonopet Model UST-2001 Ultrasonic Surgical Aspirator) with the conclusion that the new device is "substantially equivalent" in performance. No specific quantitative data points, acceptance thresholds, or sample sizes for these tests are provided in this document.

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Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.

The Cycloprobe is a single use device sold sterile. The Cycloprobe is made out of one fiberoptic, one laser machine connector, one handle for surgeon manipulation, one clear tip for placement on the eye, and a protective sheath over the fiber. On the distal side, the fiberoptic is terminated by a connector that attaches to the laser machine. On the other side, it is terminated by a fiber that has a ball lens formed onto the end that protrudes slightly from the clear tip. The connector configuration is chosen based on the surgeons' laser machine requirements. The total length of the device is 7 feet.

This document is a 510(k) summary for the Katalyst Cyclophotocoagulation Probe, indicating that it is a medical device application to the FDA, asserting substantial equivalence to a predicate device. It primarily focuses on the regulatory approval process and does not contain information about clinical studies with human readers or AI algorithms for diagnostic purposes. As such, many of the requested fields are not applicable to the content provided.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) application asserting substantial equivalence, the "acceptance criteria" are the characteristics of the predicate device, and the "reported device performance" are the characteristics of the applicant device. The document states that the performance is "identical" to the predicate.

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 states "Clinical Testing was not required to prove substantial equivalence." The evaluation was based on bench testing.

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. No clinical testing with expert assessment of ground truth was conducted.

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

Not applicable. No clinical testing with ground truth adjudication 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 surgical probe, not an AI diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a surgical probe, not an AI algorithm.

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

Not applicable. No clinical ground truth was established as clinical testing was not conducted. The "ground truth" for substantial equivalence was the characteristics and performance of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve AI algorithms that require a training set.

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

Not applicable. No AI training set was used.

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The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.

This device is a disposable Kogent™ Spetzler Lighted Suction Tubes, designed for single use in surgical procedures. Lighted Suction Tubes require connection with a suitable operating room suction system to deliver suction as well as with a suitable illumination machine. Lighted Suction Tubes are designed to provide illumination while having the ability to aspirate the surgical site. The devices are provided sterile by Ethylene Oxide and in sterile packaging.

The provided document is a 510(k) Pre-market Notification for a medical device called "The Kogent™ Spetzler Lighted Suction Tubes." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.

Therefore, much of the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, and training set details for AI/software devices cannot be found in this document, as it describes a physical surgical instrument, not an AI or software-based medical device.

However, I can extract the relevant information about the "acceptance criteria" as described in this 510(k) submission, which primarily revolves around demonstrating substantial equivalence through bench testing and comparison to a predicate device.

Here's the information that can be extracted, interpreted within the context of a 510(k) submission for a non-AI surgical device:

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

For a 510(k) submission for a physical device, "acceptance criteria" are generally evaluated by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is reported in terms of equivalence or similarity in key characteristics.

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

• Test Set Sample Size: The document mentions "Bench testing was performed on the Kogent™ Spetzler Lighted Suction Tubes to verify the design inputs." However, it does not specify the sample size (e.g., number of units tested). This is typical for engineering bench tests for this type of device, where specific product units are tested to confirm design specifications.
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Katalyst Surgical, LLC, which is based in Chesterfield, MO, USA. This is prospective testing conducted specifically for this submission.

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)

This question is not applicable to a 510(k) submission for a non-AI surgical instrument. The "ground truth" for a physical device's performance is established through objective engineering measurements and adherence to recognized standards, not by expert consensus on interpretations as would be the case for an AI diagnostic device.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, typically for AI or diagnostic devices. For this physical surgical device, performance is evaluated against engineering specifications and relevant standards.

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. An MRMC study is relevant for diagnostic or AI-assisted interpretation tasks. This document is for a basic surgical illumination and suction device.

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

Not applicable, as this is not an algorithm or AI device.

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

The "ground truth" (or basis for verification) in this context involves:

• Engineering specifications and measurements: Verifying design dimensions and characteristics.
• Industry Standards: Compliance with IEC 60601-1 (electrical safety) and ISO 10993 (biocompatibility).
• Direct comparison to a legally marketed predicate device: Demonstrating equivalence in performance and characteristics.

8. The sample size for the training set

Not applicable, as there is no "training set" for a physical surgical device in the way there is for an AI algorithm.

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

Not applicable, as there is no "training set" for this type of device.

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Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments.

The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900mm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.

The Katalyst Revolver Laser Probes are cables made out of one fiber optic (Single-Use), one laser adapter(Reusable), and one handle (Reusable) for surgeon manipulation, metal tubing extending from the handle which penetrates into the surgical site and protective sheath over the fiber.

The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm.

The fiber for illumination transmission is made out of either glass or plastic.

The illumination fiber (glass or plastic) is between 100 and 750 microns in size (measure based on the core diameter). The laser fiber (glass) is between 150 and 300 microns in size (measure based on the core diameter).

The tubing is provided in four different variations are referred to as straight, Curved, Flex-Curved, Steerable and Articulating. The configuration is chosen based on the surgeon requirements. The total length of the device is 8-10 feet.

In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1-2 feet, while both branches run for the remainder of the 8-10 feet with each branch having its own protective sheath and each branch ending with its own adapter. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.

The Revolver Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm. The Revolver Illumination Probes can only be used with the light wavelength range of 425nm to 700nm.

This document is a 510(k) summary for the Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes, and Revolver Illuminated Probes. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance data as might be found in a PMA.

Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria is not explicitly present in the provided text in the typical format of a clinical trial report. The document describes bench testing and biocompatibility testing to support substantial equivalence, but not a study designed to meet specific performance "acceptance criteria" as you've requested for an AI/device performance.

However, I can extract the relevant information and present it in a way that aligns with your request as much as possible, interpreting "acceptance criteria" as the performance specifications and "study" as the testing performed for substantial equivalence.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for Katalyst Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes

The provided document describes substantial equivalence testing for a medical device rather than a standalone performance study with explicit acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The "acceptance criteria" are implicitly met by demonstrating that the new device performs comparably to the predicate device and adheres to relevant standards. The "study" mentioned is primarily a series of bench tests and biocompatibility assessments designed to support this substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets (e.g., minimum sensitivity, maximum false positive rate) are not stated for a diagnostic or AI device, I will use the performance specifications and comparison to the predicate device as the "acceptance criteria" and "reported device performance," respectively.

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

• Sample Size: Not explicitly stated as a number of distinct devices tested for each performance characteristic. The testing appears to have been done on representative samples of the Katalyst Revolver Probes and predicate devices for comparison.
• Data Provenance: The data comes from bench testing performed by the manufacturer (Katalyst Surgical, LLC) and specialized labs (e.g., Toxikon, Inc. for biocompatibility). The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission. No information about country of origin of the data beyond the name of the testing labs is provided.

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

• This device is a surgical instrument (laser probe/illuminated probe), not a diagnostic AI device requiring expert-established ground truth. Therefore, this information is not applicable to this 510(k) submission. The performance testing focuses on physical and operational characteristics and comparison to a predicate, not diagnostic accuracy.

4. Adjudication method for the test set

• Not applicable as this is not a diagnostic device requiring expert adjudication of results. Performance is measured against physical specifications and direct comparison.

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 surgical tool, not an AI-assisted diagnostic or interpretative system.

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

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

7. The type of ground truth used

• The "ground truth" for this type of device is primarily defined by engineering specifications, established industry standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate devices. For biocompatibility, the ground truth is defined by the requirements of ISO 10993.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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The Kogent Disposable Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation of tissue. The Kogent Disposable Irrigating Bipolar Forceps are a single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

This device is a disposable bipolar forceps, designed for single use in electrosurgical procedures. They require connection with a suitable bipolar cable to the bipolar output of an electrosurgical generator. These forceps are designed to grasp, manipulate, coagulate, and irrigate, when applicable, selected tissues. The irrigation tube is designed to carry fluid to the tips of the instrument. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator and activated by a footswitch. The devices are provided sterile by ethylene oxide and in sterile packs.

The provided text describes performance testing for the "Kogent Bipolar Forceps" as part of a 510(k) submission to demonstrate substantial equivalence to predicate devices. The study conducted is primarily bench testing focusing on electrical safety and mechanical integrity for an electrosurgical device, rather than a clinical study evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, many of the requested fields are not applicable to this type of device and study.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For "Dielectric Withstand" and "Resistance/Continuity", the "Result" column is empty in the original table, so it is marked as N/A here. However, since the overall summary states that "Performance" is "Identical" to predicate devices, it can be inferred that these tests also passed or met the criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. For bench testing of medical devices like forceps, the sample size usually refers to the number of devices tested. This information is typically detailed in the full test report, not in the 510(k) summary.
• Data Provenance: This is bench testing data, not human patient data. It is generated during the device's manufacturing and quality control process. The country of origin of the data would be the location where Katalyst Surgical, LLC conducted its testing, likely the USA (Chesterfield, MO, as per the manufacturer's address). The data is prospective in the sense that it pertains to the newly manufactured Kogent Bipolar Forceps being submitted for clearance.

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

• N/A. This study is not evaluating an AI algorithm or a diagnostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance testing is established by engineering standards and specifications (e.g., IEC 60601-2-2).

4. Adjudication Method for the Test Set

• N/A. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases. This is bench testing against established engineering standards. The pass/fail criteria are objective metrics based on those standards.

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

• No. This is not an AI-enabled device, nor is it a diagnostic tool where human reader performance would be evaluated with or without AI assistance. This section is not applicable.

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

• N/A. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The ground truth for this device's performance is defined by established international and national standards for electrosurgical equipment, specifically IEC 60601-2-2, and the internal design specifications of the device. These standards define the acceptable limits for parameters like leakage current, dielectric strength, and anchorage.

8. The Sample Size for the Training Set

• N/A. This is not an AI algorithm requiring a training set.

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

• N/A. This is not an AI algorithm requiring a training set.

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For use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelength of 500nm to 900nm.

The laser probes are cables made out of one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates into the surgical site, and protective sheath over the fiber.

The illuminated laser probes (referred to also as "laser/illumination probes") are cables made out of two fiberoptics (one for laser and one for illumination), one laser connector, one illumination connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle, and protective sheath over both fiberoptics.

On one side, the distal side, the fiberoptic is terminated by a connector that attaches to the machine, be it laser or illumination. On the other side, it is terminated by a stainless steel tubing which penetrates into the eye, and may be 20g, 23g, or 25g in size in case of laser probes, or 20g in case of laser/illumination probes.

The fiber for laser transmission is made out of glass, and is restricted for use within the wavelength range of 500nm to 900nm. The fiber for illumination is made out of either glass or plastic. The tubing is provided in two shapes, referred to as straight or curved. The configuration is chosen based on the surgeon requirements. The total length of the device is 10 feet.

In case of laser and illumination functionalities provided by the same probe, the common protective sheath runs for 1 foot, while both branches run for 9 feet with each branch having its own protective sheath and each branch ending with its own connector. The same tubing will then hold within its internal diameter the laser fiber and the illumination fiber.

The provided text describes a 510(k) submission for the Katalyst Laser Probes & Illuminated Laser Probes. It primarily focuses on demonstrating substantial equivalence to predicate devices through various bench tests and comparisons of technological characteristics, rather than establishing specific acceptance criteria for performance metrics through a clinical study.

Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in the provided document.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria or quantifiable performance metrics in the format usually associated with a clinical study comparing a device's performance against a predefined threshold. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through various bench tests and qualitative comparisons.

The "Comparison Result" column in the table below indicates how the new device's characteristics compare to the predicate devices, essentially serving as a qualitative "acceptance criteria" for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: This information is not provided in the document. The submission references "Bench testing performed on this device," but does not specify the number of units tested.
• Data Provenance: This information is not provided. The testing appears to be internal bench testing rather than using external patient data.

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

• This information is not applicable/not provided. The submission focuses on bench testing and comparison to predicate devices, not on a study requiring expert-established ground truth from patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable/not provided, as there is no mention of a study involving human readers or a need for 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:

• No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (laser probes), not an AI diagnostic or assistive system.

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

• No, a standalone algorithm performance study was not done. This device is a physical instrument for surgery and does not involve an algorithm in the sense of AI or image analysis.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is engineering specifications, performance standards, and comparison to existing predicate devices. For example, optical output was compared to be "identical," and material properties were compared to be "identical." The safety and effectiveness claims are based on meeting these technical benchmarks and their equivalence to known safe and effective predicate devices.

8. The Sample Size for the Training Set:

• This information is not applicable/not provided. The device is a physical instrument and there is no mention of a "training set" in the context of an algorithm.

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

• This information is not applicable/not provided for the same reasons as #8.

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