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Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

Electrodes with HF-cable 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 conductive irrigation fluid as part of a resectoscope system. 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 with HF cable 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 accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side. The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr, range in length from 261.8-336.7mm, and range in tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

This document is a 510(k) Premarket Notification from the FDA regarding Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable. It describes the device, its intended use, and its equivalence to a predicate device.

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

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as this is a traditional medical device (electrodes) rather than a diagnostic device or AI algorithm with such measures. Instead, the acceptance criteria are based on demonstrating comparable safety and effectiveness to the predicate device through various non-clinical performance and safety tests, and compliance with relevant standards.

Here's a summary of the performed tests as evidence of meeting safety and effectiveness requirements:

The study concluded that "The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device."

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

The document describes non-clinical performance and safety testing. It does not refer to "test sets" in the context of patient data. The samples for testing would be units of the device itself (electrodes and cables). The specific number of devices tested for each non-clinical test (e.g., how many electrodes were subjected to lifetime connection/disconnection tests) is not explicitly stated in this summary.

The provenance of this data is from regulatory submissions to the FDA, originating from the manufacturer, Olympus Winter & Ibe GmbH, which is located in Hamburg, Germany. The tests are non-clinical (laboratory/bench tests), not clinical studies; therefore, terms like retrospective/prospective or country of origin of patient data are not applicable.

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 is not applicable as the document describes non-clinical testing for a traditional medical device (electrosurgical electrodes and cables), not a diagnostic device or AI algorithm requiring expert-established ground truth from patient data.

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

This is not applicable for the reasons stated above.

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

This is not applicable for the reasons stated above. The device is an electrosurgical 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

This is not applicable for the reasons stated above. The device is a physical electrosurgical electrode and cable, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" or reference for evaluating performance is typically defined by:

• Engineering specifications and design requirements: For mechanical, electrical, and functional performance.
• Applicable national and international standards: For electrical safety (e.g., IEC 60601 series), sterilization (ISO 11135), packaging (ISO 11607-1, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and biocompatibility (ISO 10993 series).
• Comparison to the predicate device: The goal is to demonstrate that the subject device is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. The device is a traditional medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

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

The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system.

Specific indications:

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

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 accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side.

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr. range in length from 261.8-336.7mm, and range in compatibility with telescopes with a direction of view of 12° - 30°. The design of the HF cable plugs vary depending on which electrosurgical generator they are compatible with.

All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

The provided document is a 510(k) summary for Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable (K171965). This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a standalone clinical study involving acceptance criteria as typically understood for new major medical devices or AI algorithms.

Therefore, the acceptance criteria and study information typically requested for AI/ML performance are not present in this type of submission. This device is an accessory to electrosurgical units, and its substantial equivalence is primarily demonstrated through comparisons to predicate devices in terms of design, materials, indications for use, and adherence to recognized electrical safety and sterilization standards.

Here's how to interpret the available information against your request:

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

This document does not present "acceptance criteria" for device performance in the typical sense of a clinical outcome or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to a predicate device. The "reported device performance" refers to its ability to meet these standards and exhibit similar characteristics 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)

This information is not applicable and therefore not provided in the 510(k) summary. The submission focuses on engineering and bench testing, not clinical performance data that would involve a "test set" in the context of AI/ML or clinical trials. The performance data relies on testing previously reviewed and deemed acceptable in K152092.

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 is not applicable to the type of device and submission. There is no "ground truth" to be established by clinical experts for the electrical safety, sterilization, or shelf-life testing of these electrodes.

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

This is not applicable for the reasons stated above.

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

This is not applicable. This is a medical device accessory, not an AI/ML diagnostic or assistive tool.

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

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

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

For the technical aspects (electrical safety, sterilization, shelf life), the "ground truth" is adherence to established international and national standards (e.g., ISO, AAMI/ANSI IEC standards) and validated engineering test results. For substantial equivalence, the "ground truth" is the previously cleared predicate device (K152092) and its established safety and effectiveness.

8. The sample size for the training set

This is not applicable. There is no software algorithm or AI model being trained for this device.

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

This is not applicable.

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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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RESECTION ELECTRODES: The Omnitech HF Resection electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation, or removal of soft tissue and where hemostasis is required. The specific urological indications in the prostate, bladder and bladder neck. The procedures for which the devices can be used are: Transurethral resection in saline (TURis). Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, Transurethral incision of the prostate (TUIP) or bladder neck, Transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

VAPORIZATION ELECTRODE: The Omnitech HF Vaporization electrode for plasma vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethral Electro vaporization (TUVP), (TVP), (TVP), (TVP), (TVP), (TUEVP) also known as Transurethral Vapor Resection of the prostate (TUVRP), Transurethral Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

Not Found

I am sorry, but the provided text is a 510(k) summary document from the FDA for medical device clearance. It does not contain the detailed information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that you are requesting.

The document primarily focuses on:

• Device Identification: Trade/Device Name, Regulation Number, Product Code.
• Regulatory Determination: Substantial Equivalence (SE) to a predicate device.
• Indications for Use: What the device is intended for (resection and vaporization of soft tissue in urological procedures).
• Regulatory Compliance: General controls and other regulations the manufacturer must adhere to.

Therefore, I cannot extract the information requested for point 1 through 9 from the provided text. This type of detailed study information is usually found in the supporting technical documentation submitted by the manufacturer to the FDA, not in the final clearance letter.

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Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.

Gynecology: Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in nonconducting irrigation fluid.

Specific intended use Gynecology:

• -Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
• -Lysis of intrauterine septa
• -Endometrial ablation

The Olympus Resection Electrodes that are subject to this submission are either monopolar or for application in saline. The main difference between monopolar electrosurgery and electrosurgery in saline is that while in monopolar electrosurgery a neutral electrode is required, whereas in electrosurgery in saline the (neutral) return electrode is part of the surgical device.

Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporisation 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, bands, rollers, needles or buttons.

All subject Resection Electrodes are single-use electrodes and are delivered sterile.

This document is a 510(k) Premarket Notification from the FDA for Olympus Winter & Ibe Gmbh's electrodes. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria in the typical sense of algorithm performance metrics.

Therefore, many of the requested sections about acceptance criteria and study design for performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device's technical specifications, indications for use, and a comparison to predicate devices based on safety and effectiveness, rather than a clinical performance study with numerical acceptance criteria.

However, I can extract information related to the safety and material performance testing mentioned in the document.

1. Table of acceptance criteria and the reported device performance

The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's clinical efficacy in the way an AI or diagnostic device submission might. Instead, the "acceptance criteria" are implied by adherence to recognized international standards for various non-clinical tests. The reported "performance" is that these tests were conducted and the device complied with the requirements of these standards, supporting its safety and effectiveness.

• AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010 (Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance).
• AAMI/ANSI/IEC 60601-2-2 2009 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety And Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories).
• IEC 60601-2-18:2009 (Medical Electrical Equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment). The implied acceptance is that the device is electrically safe for its intended use. | Electrical Safety was tested according to the listed standards. |
  | Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 and IEC 60601-2-2 for the resectoscope system. The implied acceptance is that the device, as part of the system, operates without causing or being unduly affected by electromagnetic disturbances. | EMC testing was conducted for the resectoscope system (not standalone electrodes). It was demonstrated that "the compatible resectoscope system complies with all requirements of IEC 60601-1-2 and IEC 60601-2-2." It is assumed that since electrodes are made of similar conductive materials and contain no electrical components, they will not affect the electrical properties of the system. |
  | Thermal Safety | Compliance with AAMI/ANSVIEC 60601-2-2 2009 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories). The implied acceptance is that the device does not reach unsafe temperatures during operation. | Tested according to AAMI/ANSVIEC 60601-2-2 2009. |
  | Sterilization | Compliance with ISO 11135 for the EtO sterilization cycle and conformity with AAMI ANSI ISO 11607-1:2006 for packaging. A Sterility Assurance Level (SAL) of 10-6 must be reached. EtO residuals must be within limits. | Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated, and an SAL of 10-6 was reached. EtO residuals are within limits. |
  | Shelf Life | Adequate performance and package integrity over the declared shelf life. | Shelf life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 5 years. |
  | Performance Testing Bench | Mechanical and electrical performance, resection/coagulation effectiveness, durability, and transport/packaging integrity. Implied acceptance is that the devices perform their intended functional tasks reliably and safely. | Conducted tests include mechanical and electrical performance testing, resection/coagulation testing, durability testing, and transport/packaging testing. (No specific numerical results or thresholds provided, but the statement indicates compliance was achieved to support substantial equivalence). |

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

This document describes non-clinical performance and safety testing. It does not refer to a "test set" in the context of diagnostic performance or AI model evaluation. The tests mentioned (biocompatibility, electrical safety, thermal safety, sterilization, shelf life, bench testing) were conducted on device samples to ensure compliance with standards. The sample sizes for these engineering and materials tests are not specified in the summary but would be determined by the specific test protocols for each standard. Data provenance is not applicable as it is laboratory testing for device characteristics, not patient data.

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 is not applicable to the type of testing described. "Ground truth" in the context of expert consensus on medical images or diagnoses is not a component of this submission for an electrosurgical device. The ground truth for the performance tests would be the established scientific and engineering principles and the requirements defined within the referenced international standards.

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

Not applicable. This concept applies to human reader studies or similar diagnostic performance evaluations, which were not part of this 510(k) submission.

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

Not applicable. This is a premarket notification for electrosurgical electrodes, not an AI-assisted diagnostic device. No MRMC study or AI component is mentioned.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for this submission is based on adherence to recognized international standards and engineering principles. For example:

• Biocompatibility: Defined by ISO 10993-1.
• Electrical Safety: Defined by AAMI/ANSI ES 60601-1, AAMI/ANSI/IEC 60601-2-2, IEC 60601-2-18.
• EMC: Defined by IEC 60601-1-2 and IEC 60601-2-2.
• Sterilization: Defined by ISO 11135 and AAMI ANSI ISO 11607-1:2006.
• Thermal Safety: Defined by AAMI/ANSVIEC 60601-2-2.
• Functional Performance: Evaluated against design specifications and predicate device performance.

There is also a "Clinical Evaluation" mentioned, which was a "comprehensive literature review" rather than new clinical data or expert consensus on cases.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's a medical device, and the testing outlined is for manufacturing, material properties, and safety.

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

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

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