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Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in saline irrigation fluid.

Specific indications:

• transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
• lysis of intrauterine septa
• endometrial ablation .

The Olympus Resection Electrodes that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting.

The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, rollers, needles or buttons.

All subject Resection Electrodes are single-use electrodes and are delivered sterile and are used in combination with a reusable HF cable (the HF cable is not subject to this submission).

This device is a set of Resection Electrodes for gynecological applications. The submission states that the subject device is identical in design and manufacturing to the predicate device (K152092), and therefore, the current submission relies on performance testing, sterilization, and packaging validation testing previously reviewed and deemed acceptable in K152092.

As such, without access to the K152092 submission, I cannot provide details on the specific acceptance criteria, study design, sample sizes, expert qualifications, or ground truth methods. The provided document for K161600 only states that the performance data for K161600 is based on the performance data of K152092 without re-presenting the actual data for K152092.

However, based solely on the information provided in the K161600 document, I can infer the following about what would have been implicitly accepted given the "identical" claim:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in K161600 as it defers to K152092. It would typically include metrics related to electrosurgical performance (e.g., cutting efficiency, coagulation effectiveness, impedance characteristics, thermal spread, mechanical stability of the electrodes under stress, durability during use, material biocompatibility, and electrical safety).

2. Sample sizes used for the test set and data provenance: Not explicitly stated in K161600. These would have been part of the studies for predicate device K152092.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not explicitly stated in K161600. If clinical studies were part of K152092, expert evaluation would have been involved, likely by urologists (for the predicate device's original indication) or potentially other surgeons if generalized tissue effects were assessed.

4. Adjudication method for the test set: Not explicitly stated in K161600.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is more common for diagnostic imaging AI devices, not electrosurgical electrodes.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical tool, not an AI algorithm. Its performance is always in conjunction with human use.

7. The type of ground truth used: Not explicitly stated in K161600. For electrosurgical devices, ground truth might involve objective measurements of tissue effect (e.g., depth of coagulation, width of cut, histological analysis post-ablation), electrical parameters, and mechanical testing results, rather than expert consensus on diagnostic images.

8. The sample size for the training set: Not applicable. This device is an electrosurgical tool, not an AI/ML algorithm that relies on a training set.

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

However, the document does contain information about the regulatory review and basis for substantial equivalence:

Summary of Acceptance Criteria and Study (Implicitly from K152092):

Since K161600 claims identical design and manufacturing to K152092 and relies on K152092's performance data, the acceptance criteria and study would have been related to demonstrating the safe and effective performance of electrodes for electrosurgical cutting and coagulation.

Key Performance Data Categories (Inferred from industry standards for electrosurgical devices):

• Electrical Performance: Power output, impedance matching, current distribution, absence of arcing.
• Thermal Performance: Controlled tissue heating, minimal collateral thermal damage, effective coagulation/cutting.
• Mechanical Integrity: Durability of the electrode tip, insulation, and shaft during simulated use; resistance to bending and fracturing.
• Biocompatibility: Confirmation that materials are biocompatible (typically by testing or established use).
• Sterilization Validation: Ensuring the device can be consistently sterilized.
• Packaging Validation: Ensuring sterility is maintained until use and transit integrity.

How the Device Meets Acceptance Criteria:

The device meets the acceptance criteria by being identical in design and manufacturing to the previously cleared predicate device K152092, whose performance data was already deemed acceptable by the FDA for urological indications. The K161600 submission argues that despite different indications (gynecological vs. urological), the "intended use" is the same (electrosurgery in saline) and there is an "extensive knowledge base regarding the use of bipolar electrosurgery for gynecological applications." This implies that the fundamental performance characteristics demonstrated in K152092 are transferable and acceptable for the new indications.

The document explicitly states:

• "The subject device is identical in design and manufacturing to the predicate device (K152092). Therefore, the current submission relies on performance testing previously reviewed and deemed acceptable in K152092."
• "Sterilization is performed according to ISO 11135 and packaging conforms with ISO 11607-1. Since the subject device is identical in design and manufacturing to the predicate device, the current submission relies on sterilization and packaging validation testing previously reviewed and deemed acceptable in K152092."

Therefore, the "study that proves the device meets the acceptance criteria" is the original set of studies performed for the K152092 submission, which are not detailed in this document.

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The ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids.

The ConMed/Linvatec LightWave" Integrated Electrode Ablators are a modification of the currently marketed 3.2 mm UltrAblator electrode (Linvatec, K030720) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device. One version incorporates handcontrolled buttons to actuate the "cut" and "coag" functions of the electrosurgical generator. Another version is actuated by foot-control to control "cut" and "coag" functions of the electrosurgical generator. The hand-controlled and foot controlled version consists of an electrical insulation coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators in distribution.

A third version of the ConMedILinvatec LightWave™ Integrated Electrode Ablators incorporates a suction/aspiration feature and is a modification of the currently marketed 3.2 mm Ult Ablator electrode (Linvatec, K993885) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device, and is similar in technology to Heatwave Hand-Controlled Electrode (Conmed, K021299) and the VAPR™ 3.5mm 90° Suction Electrode (Mitek, K002422), which incorporate aspiration or suction. The device is similar to the hand-controlled device and will also have suction capability and attach to commonly available suction equipment. This electrode will be hollow allowing for the removal of irrigating fluids during surgical procedures.

The front switch contained in the hand-controlled devices provide the surgeon with electrosurgical cut (ablate) capability when depressed. The rear button activates electrosurgical coagulating (coag) current.

The provided text is a 510(k) submission for the LightWave™ Integrated Electrode Ablator and LightWave™ Integrated Electrode Suction Ablator. It aims to demonstrate substantial equivalence to previously marketed devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-driven device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: "ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids."
• Surgical Effect, Function, Materials of Construction, Patient Population, Compliance with Recognized Standards and Published FDA Guidance, and Manufacturing Methods.

The "study" in this context is the 510(k) submission process itself, which asserts that the new device is substantially equivalent to existing predicate devices, implying that its performance is implicitly acceptable because the predicates are already approved.

Therefore, many of the requested details about acceptance criteria for performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission for a Class II electrosurgical device relying on substantial equivalence to establish safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This document describes a new electrosurgical electrode and relies on demonstrating substantial equivalence to existing devices. It does not present a "test set" in the sense of clinical data points used to evaluate an AI or diagnostic device's performance.

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

• Not Applicable / Not Provided. Ground truth establishment by experts is not a component of this 510(k) filing for an electrosurgical device.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable / Not Provided. This is not an AI-driven device or one that involves human readers interpreting results.

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

• Not Applicable / Not Provided. This is an electrosurgical tool, not an algorithm.

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

• Not Applicable / Not Provided. The "ground truth" for this device's acceptance is its substantial equivalence to legally marketed predicate devices, which are presumed safe and effective based on their established clinical use. Testing typically involves bench testing (e.g., power output, insulation integrity, fluid flow for suction), electrical safety, and biocompatibility, not clinical "ground truth" for performance in the same way a diagnostic device would.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable / Not Provided. As per point 8, there is no training set mentioned.

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Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.

SterilMed's reprocessed electrosurgical electrodes are a monopolar electrosurgical instruments consisting of a tungsten tip, stainless steel housing, and several layers of insulation.

The provided text is a 510(k) summary for SterilMed's Reprocessed Electrosurgical Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria and performance metrics for a novel AI/software device.

Therefore, many of the requested items (e.g., AI performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies) are not applicable to this submission.

Here's an analysis of the available information:

Device: SterilMed Reprocessed Electrosurgical Electrodes

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the reprocessed device performs comparably to new, equivalent devices and meets safety standards for reuse. The submission emphasizes substantial equivalence rather than numerical performance against specific criteria.

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

The document indicates "representative samples" were used for bench testing. It does not specify a numerical sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not mentioned, as this is a reprocessed medical device submission, not a clinical study on patient data.

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

Not applicable. This submission doesn't involve establishing ground truth from expert interpretations of medical images or data. The "ground truth" here is the functional performance and safety of the reprocessed device, assessed through bench testing and process validation.

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

Not applicable, as this is not a study assessing interpretations of medical data. The evaluation is based on engineering and quality control tests.

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 an electrosurgical electrode, not an AI-powered diagnostic tool.

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" for this device's performance and safety is established through:

• Bench testing: Verifying functional characteristics (e.g., cutting ability).
• Process validation: Confirming the efficacy of cleaning, sterilization, and packaging procedures.
• Comparison to predicate devices: Demonstrating consistency in design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no "training set" for this type of device.

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The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:
Knee

1. Meniscectomy
2. Lateral Release
3. Chondroplasty
4. Synovectomy
5. ACL Debridement
6. Plica Removal
7. Meniscal Cystectomy
   Ankle
8. Fracture Debridement
9. Excision of Scar Tissue
10. Synovectomy
11. Chondroplasty
    Wrist
12. Synovectomy
13. Cartilage Debridement
14. Fracture Debridement
    Shoulder
15. Labral Tear Resection
16. Synovectomy
17. Excision of Scar Tissue
18. Acromioplasty
19. Bursectomy
20. Subacromial Decompression
21. Chondroplasty
    Elbow
22. Synovectomy
23. Tendon Debridement
24. Chondroplasty

The UltrAblator™ Electrode is a monopolar electrode which will be packaged individually or in a kit containing an UltrAblator™ Electrode, ConMed electrosurgical pencil, and a ConMed electrosurgical dispersive pad. The electrode is connected to an electrosurgical generator via the ConMed electrosurgical pencil. The device is inserted into the joint. Upon activation of the generator, the tip of the device electrosurgically ablates and coagulates tissue.
The UltrAblator™ Electrode is a modification of Linvatec's Ablator Electrode which received FDA clearance under 510(k)# K983652 on March 23, 1999. The electrode will be made available in a range of sizes from 2.4" to 6.3" inches in working length, and in three angles, 0°, 30°, & 90°. The insulating material will be changed from polyolefin shrink to Vitek powder coat.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria.

The document is a 510(k) premarket notification for a medical device (UltrAblator™ Electrode) seeking clearance from the FDA based on substantial equivalence to a predicate device. This type of submission typically focuses on ensuring safety and efficacy through comparison to an already marketed device, rather than through a detailed study proving performance against explicit acceptance criteria.

Here's what the document does provide and why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: Not present. The document describes the device, its intended use, materials, manufacturing processes (sterilization, packaging), and identifies a predicate device (Linvatec's Ablator Electrode, K983652). It also mentions "Engineering testing will be performed per ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993" for tests like Dielectric Withstand, Voltage Withstand, Run Test, and Resection Effectiveness Test, but it does not provide the acceptance criteria for these tests nor the results that demonstrate the new device meets them. It merely states that the protocols are included in an exhibit (which is not provided in the input text).

2. Sample size used for the test set and the data provenance: Not present. Since no performance study is detailed, there's no mention of a test set, its sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This information would be relevant for clinical performance studies, which are explicitly stated as "not required" for this submission.

4. Adjudication method: Not present, for the same reasons as point 3.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not present. This type of study is more common for diagnostic imaging AI systems to assess human reader improvement with AI assistance, which is not applicable to this electrosurgical electrode.

6. Standalone (algorithm only without human-in-the-loop performance) study: Not present. This is a physical electrosurgical device, not an algorithm.

7. Type of ground truth used: Not applicable, as there's no clinical performance study involving ground truth.

8. Sample size for the training set: Not applicable, as there's no AI/algorithm being trained.

9. How the ground truth for the training set was established: Not applicable, as there's no AI/algorithm being trained.

In summary, the provided document is a 510(k) notification focused on demonstrating substantial equivalence, not a detailed performance study with explicit acceptance criteria and results for the device's functional performance. It references engineering tests and biocompatibility tests but does not include the results or specific acceptance criteria within the provided text.

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The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

The HeatWave™ Electrode is a sterile, single-use, monopolar electrode designed to be used in conjunction with an electrosurgical generator via an electrosurgical pencil and a dispersive pad. The HeatWave Electrode will be sold individually and/or in a kit containing an electrode, electrosurgical pencil and an electrosurgical dispersive pad.

The provided document describes a 510(k) submission for the HeatWave™ Electrode. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence, rather than conducting new clinical studies with defined acceptance criteria and performance outcomes.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or specific performance metrics from a comparative effectiveness or standalone study.

Instead, the submission focuses on:

• Device Description: A sterile, single-use, monopolar electrode for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures.
• Intended Use: As stated above.
• Substantial Equivalence: Claimed to be substantially equivalent in design, function, and intended use to the TAC™ Probes (ORATEC Interventions, Inc.) and ArthoWand CAPS (ArthroCare Corporation).
• Testing for Safety and Effectiveness: The document briefly states, "Testing has been done to prove safety and effectiveness of the devices," but it does not provide details of this testing, including acceptance criteria or results. It is typical for 510(k) submissions to rely on non-clinical bench testing, biocompatibility testing, and electrical safety testing, but specific results are not included in this summary.
• Comparison to Predicate Devices: A table highlights similarities and dissimilarities in materials, dimensions, and sterilization methods between the HeatWave Electrode and its predicate devices.

In summary, none of the specific details about acceptance criteria, study design, statistical analysis, or expert involvement for proving device performance are present in this 510(k) summary. The FDA's clearance (K991830) is based on a finding of "substantial equivalence" to existing, legally marketed devices, not on a new clinical study demonstrating specific performance against predefined acceptance criteria.

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Device is used for cutting and/or coagulation during open surgical procedures.

Not Found

I apologize, but the provided text is a 510(k) clearance letter from the FDA for an electrosurgical device. It primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device.

The document does not contain information about:

• Acceptance criteria for a study.
• Detailed study design or methodology.
• Device performance metrics from a study.
• Sample sizes for test or training sets.
• Ground truth establishment methods.
• Information on expert qualifications or adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval, not a scientific study report.

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The bipolar ball electrodes are designed for electrosurgical coagulation of soft tissue in a bloody, irrigated or wet surgical field.

Bipolar Ball Electrodes

The provided text describes the regulatory clearance of a medical device (Bipolar Ball Electrodes) not an AI device, and therefore does not contain information about acceptance criteria, study data, or performance metrics in the way one would typically describe for a software algorithm or AI model.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against pre-defined acceptance criteria, especially not in the context of an AI device.

Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: Not mentioned. The document relies on the opinion of an expert and general descriptions of the technology's benefits compared to monopolar electrosurgery.
• Sample Size (test set), Data Provenance: Not applicable/not mentioned. No specific test set data is presented.
• Number of Experts, Qualifications, Adjudication Method: Not applicable/not mentioned.
• MRMC Comparative Effectiveness Study: Not applicable/not mentioned.
• Standalone Performance: Not applicable/not mentioned.
• Type of Ground Truth: Not applicable/not mentioned for device performance. The "ground truth" for 510(k) historically is substantial equivalence to a predicate.
• Sample Size (training set), Ground Truth (training set): Not applicable/not mentioned.

The text primarily summarizes the safety and effectiveness features of the bipolar ball electrodes and the FDA's clearance decision.

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