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The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current.
The products are intended for use in endoscopically performed or supported surgeries.
The types of surgery intended are:

• Endoscopic procedures
• Orthopedic procedures
• Neurosurgical coagulation

FlexTip Bipolar electrodes single-use consist of a handpiece with electrode front part, cable and plug. The Bipolar electrodes are available in two different working lengths. The FlexTip electrodes are encoded for RF generators Arthrex Inc. (AR-S9800 Synergy) and Sutter Medizintechnik GmbH (K171869 CURIS® RF Generator). The electrodes are provided sterile and are single-use instruments. Electrode shaft and tips are made of stainless steel and are insulated with PEBAX tubing.

The provided text describes the 510(k) premarket notification for the "FlexTip Bipolar electrodes single-use" device. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than detailing clinical studies with specific acceptance criteria in the context of AI/ML device performance.

Therefore, many of the requested details about acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, or multi-reader studies are not applicable to this submission, as it is for a physical medical device (electrosurgical electrodes) and not an AI/ML-based diagnostic or therapeutic software.

The document primarily covers bench testing, biocompatibility testing, and sterilization validation.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of quantitative acceptance criteria with numerical performance targets in the way one might for an AI/ML device (e.g., AUC > X, sensitivity > Y%). Instead, the acceptance criteria are implicitly that the device passes various engineering and biological tests, performing equivalently to the predicate device.

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

• Sample Size: Not explicitly stated in numerical terms for each test.
  • For "Thermal effects on tissue": "Three different types of tissue were used, and tests were performed in triplicate." This describes 3 samples per tissue type, tested 3 times.
  • For other bench tests, the sample size is not specified but is implicitly part of the standard testing for device validation.
• Data Provenance: The testing was conducted in line with internal R&D processes and FDA guidance. The location of the testing is not specified, but the applicant (Sutter Medizintechnik GmbH) is based in Germany. These are non-clinical bench tests, not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a physical device, and the "ground truth" is established by engineering and standard medical device performance testing, not by expert interpretation of patient data or images. "Visual comparison" for thermal effects implies a human assessment, but not by a panel of "experts" in the sense of clinical readers.

4. Adjudication Method for the Test Set

Not Applicable. No human-in-the-loop clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. MRMC studies are typically for evaluating diagnostic performance of imaging devices or AI algorithms. This submission is for an electrosurgical tool.

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

Not Applicable. This is not an algorithm or AI device. The phrase "standalone" might refer to the device's intrinsic performance, which is assessed through the various bench tests described (electrical safety, mechanical strength, thermal effects, systems performance).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is established through:

• Engineering specifications and test standards: Compliance with IEC and ISO standards for electrical safety, biocompatibility, sterilization, and packaging.
• Physical measurements and visual assessment: For mechanical strength and thermal effects on tissue (including digital morphometric measurement using histology).
• Comparison to predicate device: Demonstration of equivalent performance and characteristics to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. No training set exists.

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Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue.

Sutter Swyng® non-stick bipolar forceps, single-use are electrosurgical instruments. The bipolar forceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

The provided text describes a 510(k) submission for the Sutter Swyng® non-stick bipolar forceps, single-use. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against pre-defined acceptance criteria for a new AI/software device.

Therefore, many of the requested categories related to AI/software performance (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data relevant to this medical device's physical and functional properties, as described in the "Non-Clinical Performance Data" section.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

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 "Thermal effects on tissue," tests were performed in triplicate for three different types of tissue.
  • For other tests (Electromagnetic Compatibility, Electrical Safety, Mechanical Strength, Functionality, Sterilization, Shelf Life, Biocompatibility), specific numerical sample sizes are not explicitly stated in the provided text. The text refers to "performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the FDA guidance."
• Data Provenance: The studies were internal to Sutter Medizintechnik GmbH (Germany). The type of study (retrospective or prospective) for the bench tests is not specified, but given their nature, they would be considered controlled laboratory experiments.

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. This submission pertains to physical medical devices and their functional and safety characteristics, not AI/software performance requiring expert ground truth for classification or diagnosis. "Thermal effects on tissue" involved "visual comparison as well as digital morphometric measurement using histology," implying expert evaluation, but the number and qualifications are not specified.

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

• Not applicable. See point 3.

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. This is not an AI/software device. No MRMC study was performed.

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

• Not applicable. This is not an AI/software device.

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

• For "Thermal effects on tissue," the ground truth involved histology for digital morphometric measurement and visual comparison against the predicate device.
• For other tests, the "ground truth" refers to compliance with established international standards (IEC, ISO) and internal design specifications for safety and performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

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The ARROWtip™ Single-Use monopolar electrosurgical instrument for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The ARROWtip™ Single-Use monopolar electrode is not intended for use in the central nervous system or in the central circulatory system.

Sutter ARROW tip™ Monopolar Electrodes are electrosurgical instruments. The electrodes are provided with different angled electrode front parts and in different lengths. They are to be connected through an appropriate monopolar handpiece with the monopolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

The provided text describes the 510(k) submission for the Sutter ARROWtip™ Monopolar Electrodes. It is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies or establishing complex acceptance criteria for AI/ML-driven performance.

Therefore, the information required to populate the fields regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-driven device's performance, as outlined in your request, is not present in the provided document.

The document discusses:

• Bench Testing: Performance testing in line with FDA guidance for electrosurgical devices, including Electromagnetic Compatibility and Electrical Safety, Mechanical strength and functionality, and Thermal effects on tissue.
• Sterilization and Shelf Life Testing: Validation of the sterilization cycle and shelf-life.
• Biocompatibility Testing: Evaluation according to ISO standards.
• Comparison to Predicate: A table comparing technological characteristics with the predicate device (Stryker Leibinger Colorado MicroDissection Needles® (K033232)).

It explicitly states:

• No animal studies have been performed.
• No clinical studies have been performed.

The "Acceptance Criteria" in this context are related to meeting these engineering and biological safety standards, and demonstrating substantial equivalence to the predicate device, not statistical performance metrics for an AI/ML algorithm.

Therefore, I cannot provide the requested table and details for an AI/ML-driven device's performance, as the provided text pertains to a traditional electrosurgical instrument without AI/ML components.

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Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery.
The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring.
The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.

Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments available in different angled sheath configurations. They are to be connected to the bipolar output of the Sutter CURIS® RF Generator. The electrodes are provided sterile and are single-use devices.

The Sutter RaVoR™ Bipolar Electrodes are not an AI device, therefore, the information requested is not available in the provided text. The document refers to the device as an electrosurgical instrument for soft tissue ablation and coagulation in ENT surgery. It describes non-clinical performance data and concludes substantial equivalence to a predicate device, but does not pertain to AI/ML or require the typical acceptance criteria and study designs associated with AI devices.

However, based on the provided text, here is a breakdown of the non-clinical performance data and the study types conducted to demonstrate substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by "Pass" for each test, indicating that the device met the design specifications and performance requirements.

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

The document does not specify a distinct "test set" in the context of an AI device. Instead, it refers to a series of bench tests.

• Sample Sizes: Not explicitly stated for each bench test. For "Thermal damage / thermal spread testing," experiments were performed for both the subject and predicate device, implying multiple tests or observations to draw comparisons.
• Data Provenance: The data is from "Bench Testing" and "Non-Clinical Performance Data" conducted by the applicant, Sutter Medizintechnik GmbH. This is laboratory-based testing, not human data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable, as this is not an AI device and the ground truth for performance was established through engineering and scientific testing standards rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. The performance was assessed against technical standards and benchmarks, not through expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted as this device is not an AI algorithm requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established through:

• Engineering Standards: Compliance with international standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 11137-1, ISO 11137-2, and ISO 10993-1.
• Benchmarking against Predicate Device: Comparison of thermal effects, lesion size, and cool-down time to the legally marketed predicate device (Celon AG medical instruments, Celon ENT System, K032838).
• Laboratory Measurements: Direct measurements of physical properties, electrical characteristics, and biological interactions in controlled environments.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

Not applicable. No training set was used.

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The Sutter CURIS® RF Generator is intended for:

Orthopedic, arthroscopic, spinal and neurosurgical:

For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures

For soft tissue resection and coaqulation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist

Cutting:

Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin tags, Blepharoplasty

Blended Cutting and Coagulation:

Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal cell carcinoma, Nevi, Fistulas, Epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps

Hemostasis and nonablative Coagulation:

Control of bleeding, Epilation, Teleangiectasia

Bipolar:

Pinpoint. Precise Coagulation. Pinpoint Hemostasis in any field (wet or dry), snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage

Contraindications:

This device is not intended for vessel sealing.

The Sutter CURIS® RF Generator is a compact source of high radiofrequency RF energy to be employed for a variety of electrosurqical procedures. This is achieved by the selection of different wave forms and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Lamps give the operator feedback on the status.

The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through foot switch and/or hand switch. Monopolar and bipolar electrodes are available for use.

The maximum power output of the device in CUT mode is 100 watts (at 400 Ohms load), and 80 watts maximum in COAG mode at 50 Ohms. Operating frequency of the device is maintained at 4.0 MHz.

The device offers both monopolar and bipolar output wave forms. In monopolar mode it offers two CUT wave forms and two COAG wave forms. In bipolar mode it offers three CUT wave forms and three COAG wave forms.

The Sutter CURIS® RF Generator is packaged together with power cord and instruction manual. Optional accessories are a foot switch with cable and appropriate monopolar and bipolar cables.

The Sutter CURIS® RF Generator is an electrosurgical device that operates on high radiofrequency (RF) energy for various electrosurgical procedures. It has both monopolar and bipolar output waveforms and offers different cutting and coagulation modes. The device is not distributed as sterile and is not intended to be sterilized. It is a tabletop device, therefore, has no contact with the patient requiring no biocompatibility assessment.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a "test set" in terms of cases or patient data, as this device (an RF Generator) is evaluated through non-clinical performance testing against established standards and internal R&D processes, rather than through analysis of patient data or clinical trials with a defined test set of medical outcomes.

Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable to the type of testing described for this electrosurgical generator.

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

This is not applicable to the non-clinical performance studies conducted for this device. Ground truth, in the context of device performance, is established through compliance with recognized standards (e.g., IEC, ISO) and internal R&D process validations, not through expert consensus on medical cases.

4. Adjudication Method for the Test Set:

This is not applicable to the non-clinical performance studies for this device. Adjudication methods are typically used in clinical studies involving interpretation of medical data (e.g., imaging, pathology) by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. These types of studies are typically conducted for diagnostic devices where human readers interpret medical information, often with and without AI assistance. This device is an electrosurgical generator, and its performance is evaluated through engineering and safety testing.

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

The performance evaluation described is for the device (Sutter CURIS® RF Generator) itself, without direct human-in-the-loop performance assessment in the context of cognitive tasks or interpretation. The performance tests are described as standalone in the sense that they evaluate the device's functional and safety characteristics independent of its operational use on a specific patient.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the Sutter CURIS® RF Generator's performance is based on:

• Compliance with International Standards: Primarily IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 62304, and ISO 14971. These standards define the acceptable safety and performance parameters for electrosurgical devices.
• FDA Guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016.
• Internal R&D Process: Design specifications and performance requirements established by the manufacturer and validated through their internal testing processes.
• Comparison to Predicate Device: The predicate device serves as an established benchmark for "adequate coagulation and cutting performance," implying its known and accepted clinical efficacy and safety.

8. The Sample Size for the Training Set:

This is not applicable. The Sutter CURIS® RF Generator is a hardware device for electrosurgery, not an AI/ML algorithm that requires a training set of data.

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

This is not applicable as there is no training set for this type of medical device.

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Intended Use: Sutter Bipolar Forceps - Calvian are intended to remove tissue and control bleeding.

Sutter Bipolar Forceps - Calvian is an electrosurgical tool available in different handle styles and tip sizes. It is constructed with medical grade stainless steel, coated with Polyamide PA 11 as electrical insulator and possesses tips made of stainless steel that are partly not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is intended to remove tissue and control bleeding. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.

This is a 510(k) premarket notification for a medical device (Sutter Bipolar Forceps - Calvian), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them in the context of AI/ML, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and adherence to relevant standards for electrosurgical cutting and coagulation devices.

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Intended Use: Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation.

Indications: General surgery, Orthopaedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynaecological coagulation (except for use in female sterilisation), Urological coagulation, Ear-, Nose- and Throat coagulation.

Sutter Bipolar Forceps - SuperGliss is an electrosurgical tool in tweezers configuration with differences in tip size and branches styles. It is constructed with medical grade stainless steel (branches), coated with Polyamid PA 11 as electrical insulator and possesses a tip made of silver alloy that is not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is designed to grasp, manipulate and coagulate selected tissue. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.

The provided text describes a 510(k) summary for the "Sutter Bipolar Forceps - SuperGliss," an electrosurgical tool. This document outlines the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the information provided, here's a detailed breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the sense of specific thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to predicate devices, implying that its performance is comparable and acceptable for its intended use. The performance testing section mentions "determination of coagulation areas for various tip sizes and statistical analysis of the results," but no specific numerical results or targets are provided in this summary.

The "Features" table below highlights the comparative performance and design aspects, showing that the Sutter SuperGliss meets the characteristics of the predicate devices.

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

The document states, "Non-clinical laboratory performance testing was done on different types of meat with determination of coagulation areas for various tip sizes and statistical analysis of the results."

• Sample Size: Not specified. The phrase "different types of meat" suggests multiple samples were used, but the exact number is not provided.
• Data Provenance: Not specified, but generally, bench testing results conducted by the manufacturer are not typically tied to a specific country of origin in the same way clinical trial data might be. This was a non-clinical laboratory performance test. It's implicitly retrospective as it was conducted by the manufacturer for the submission.

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

Not applicable. This device is an electrosurgical instrument, and the performance testing involved physical measurements of coagulation areas on meat, not human interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the testing involved physical measurements, not observational assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is a surgical instrument, and its performance was assessed through non-clinical laboratory tests.

6. Standalone Performance Study

Yes, a standalone performance study was performed in the form of "Non-clinical laboratory performance testing... on different types of meat with determination of coagulation areas for various tip sizes and statistical analysis of the results. Bench testing according to standards series IEC 60601 has also been performed." This describes the device's performance in isolation from a human operator, focusing on its functional capabilities.

7. Type of Ground Truth Used

For the non-clinical laboratory performance testing, the ground truth was direct physical measurement of "coagulation areas" on "different types of meat." For compliance with IEC 60601, the ground truth rested on fulfilling the requirements of that established standard.

8. Sample Size for the Training Set

Not applicable. This is a medical device (surgical instrument), not an AI/ML algorithm that requires a training set. The performance testing aims to demonstrate the device's functional integrity and equivalence, not to train a model.

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

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

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To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.

Sutter Electrosurgical Cables are electrosurgical accessories designed to transfer electrosurgical power to monopolar and bipolar instruments from an electrosurgical generator. The cables are designed to fit standard monopolar/bipolar instruments and generator connectors. Sutter Electrosurgical Cables are supplied non-sterile, and can be reused after cleaning and steam sterilization.

This 510(k) summary is for electrosurgical cables, which are accessories for a medical device. The document states that the cables were validated through "testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission." However, the provided text does not contain Section 17, nor does it detail specific acceptance criteria or the reported device performance in a quantifiable manner. It primarily asserts substantial equivalence to predicate devices based on design concepts, technologies, and materials, and general safety and effectiveness claims.

Therefore, much of the requested information cannot be extracted from the provided text.

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

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

• Acceptance Criteria: Not explicitly stated in the provided text. The submission refers to "Standards mentioned in Section 17," which is not included.
• Reported Device Performance: Not explicitly stated in the provided text in a quantifiable manner (e.g., specific thresholds or measurements). The conclusion states: "Testing demonstrates that these devices are as safe, as effective, and perform as well as or better than the legally marketed devices."

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: Not specified.
• Data Provenance: Not specified. The submitter is "Sutter Medezintechnik GmbH, Tullastrasse 87, 79108 Freiburg Germany," suggesting the testing might have occurred in Germany, but this is not explicitly stated as the provenance of the test data. The submission also states the cables are "supplied non-sterile, and can be reused after cleaning and steam sterilization," which implies certain sterilization validation tests would have occurred, but details are not provided.

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 mentioned. This type of information is typically relevant for studies involving subjective interpretation of medical images or clinical outcomes, which is not the case for electrosurgical cables. Testing for such devices usually involves engineering and performance standards.

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

• Not applicable/Not mentioned. This is typically used in clinical studies with human assessors.

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-enabled device.

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

• Not applicable. This is not an AI-enabled device. This refers to the performance of the electrosurgical cables themselves in a simulated or actual use environment according to engineering standards. The document only generically states "testing," without providing specifics of whether it was standalone performance or involved human components of a system.

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

• Not applicable in the human interpretation sense. For electrosurgical cables, "ground truth" would likely refer to established engineering performance standards (e.g., electrical conductivity, insulation integrity, mechanical strength, biocompatibility, sterilization efficacy) as defined by the "Standards mentioned in Section 17." The document explicitly states "Sutter Electrosurgical Cables were validated through testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission."

8. The sample size for the training set

• Not applicable. This is not an AI-enabled device that uses a "training set."

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

• Not applicable. This is not an AI-enabled device that uses a "training set."

Summary of available information:

The provided 510(k) summary for Sutter Electrosurgical Cables primarily focuses on demonstrating substantial equivalence to predicate devices. It states that "Sutter Electrosurgical Cables were validated through testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission." However, the specific details of these standards, the acceptance criteria derived from them, and the quantitative performance results are not included in the provided text. The document asserts that "Testing demonstrates that these devices are as safe, as effective, and perform as well as or better than the legally marketed devices."

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