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RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch.

There are three handpieces. RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

This document is an FDA 510(k) clearance letter for an RF Electrosurgical Device (RFMagik). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain information about acceptance criteria, device performance results, sample sizes, expert ground truth establishment, or clinical study details. The section on "Clinical Testing" explicitly states: "Clinical testing is not a requirement and has not been performed."

The document focuses on:

• Regulatory details: Device classification, product codes, indications for use.
• Technological comparison: Detailed comparison of the subject device (RFMagik) with a primary predicate device (RFMagik Lite) and a reference device (AGNES). This comparison highlights similarities and differences in handpieces, electrodes, output power, etc., and explains why these differences do not affect substantial equivalence.
• Non-clinical testing: Biocompatibility, sterility, shelf-life, and performance bench testing. An "Ex Vivo Study" was conducted on tissue types (liver, skin, muscle) for thermal testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for the test set, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. This information is typically found in specific study reports or sections of a 510(k) submission that go beyond what is published in the clearance letter itself.

The document indicates that the substantial equivalence was primarily demonstrated through bench testing and comparison to predicate devices, rather than clinical trials or extensive human-in-the-loop performance studies.

Summary of what CANNOT be provided from the given document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size for the test set and data provenance: No clinical test set. Ex vivo study mentioned, but specific sample sizes are not detailed.
3. Number of experts and qualifications for ground truth: Not applicable as no clinical study with expert ground truth review was performed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical electrosurgical device, not an AI algorithm.
7. Type of ground truth used: Not applicable for a clinical study. Ex vivo study used physical tissue, but no "ground truth" akin to medical image labeling.
8. Sample size for the training set: Not applicable as there is no mention of an AI/ML algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

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Electrotherapy Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electrotherapy Electrodes are intended to be used with marketed Electrical Stimulators, (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation)) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

Electrotherapy Electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, flexible structures composed of laminated materials commonly used in the application:

1st layer: Insulation material: Tan fabric
2nd layer: Double sides adhesive tape
3rd layer: Conductive film (Carbon Film)
4th layer: Self-adhesive conductive hydrogel
5th layer: Plastic release film
Connection: Leadwire/Snap button

The electrodes are designed for single-patient & single application use. Because of the adhesive nature of the conductive hydrogel, no securing materials are required to secure the device to the patient's skin.

The provided FDA 510(k) clearance letter and summary for the Electrotherapy Electrodes (K250841) does not describe a study involving AI or human reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Therefore, many of the requested details about acceptance criteria for AI and human performance studies, expert involvement, adjudication, MRMC studies, standalone AI performance, and ground truth establishment cannot be found in this document.

However, I can extract the acceptance criteria and performance data related to the non-clinical tests that were performed to demonstrate substantial equivalence for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

The device, Electrotherapy Electrodes (K250841), is a Class II cutaneous electrode. The study described focuses on demonstrating its substantial equivalence to a predicate device (ZMI Self-Adhesive Electrodes, K180865) primarily through non-clinical performance and biocompatibility testing. No AI component or human reader study is discussed.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia.

The Electronic Sphygmomanometers, including ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24, is suitable for measurement of systolic blood pressure and diastolic blood pressure of adult person and adolescents 18 to 21 years old with arm circumference ranging from 22 cm to 42 cm by the oscillometric technique. The error is controlled within the range specified in IEC 80601-2-30 Non-invasive automated monitor. User can select the blood pressure unit mmHg or kPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated.

The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and cuff. And all models are powered by 4 AAA dry batteries (DC 6V).

The device has a memory function that automatically stores 2*99 sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function.

The seven models have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard; only appearance have some difference.

The provided FDA 510(k) clearance letter and synopsis for the Electronic Sphygmomanometers (K250185) primarily focus on demonstrating substantial equivalence to a predicate device, rather than detailing a specific clinical study with granular acceptance criteria for an AI-powered diagnostic device. The application is for a standard medical device (blood pressure monitor), not an AI/ML-driven diagnostic tool. Therefore, many of the requested points for an AI study (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect size of AI assistance, training set details) are not applicable or provided in this document.

However, I can extract and infer information relevant to the device's accuracy and performance validation using the provided text, particularly concerning the mentioned standards and the comparative clinical study.

Here's an attempt to describe the acceptance criteria and study as best as possible given the provided non-AI-specific document:

Device: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

Study Type: Comparative Clinical Study (for substantial equivalence to a predicate device and mercury sphygmomanometer) and Non-Clinical Performance Testing.

Regulation/Standard for Accuracy: IEC 80601-2-30, ISO 81060-2 (including Amendment 1(2020)), and FDA Guidance No-Invasive Blood Pressure (NIBP) Monitor Guidance.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for non-invasive blood pressure monitors, as per ISO 81060-2 (which is explicitly listed as a standard the device complies with), relies on statistical analysis of difference between the device's readings and a reference standard (usually mercury sphygmomanometer readings or an established method). The key metrics are:

• Mean Difference (Bias): The average difference between the device reading and the reference reading.
• Standard Deviation of the Differences: A measure of the spread of these differences.

The ISO 81060-2 standard (for clinical validation of automated measurement type) typically requires:

• Mean difference between the test device and reference measurement: $\leq \pm 5$ mmHg
• Standard deviation of the differences (SD): $\leq 8$ mmHg

Note: The reported accuracy of $\pm 3$ mmHg or 2% of the reading for pressure is a general accuracy specification, not necessarily the mean difference and standard deviation from the clinical validation as per ISO 81060-2. However, achieving $\pm 3$ mmHg as a general accuracy implies that the device is likely to meet or exceed the ISO 81060-2 criteria. The document states compliance with ISO 81060-2, meaning it passed these criteria.

2. Sample Size and Data Provenance

• Test Set (Clinical Study): The document states, "We conducted a comparative clinical study to verify the performance of the proposed device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2."
  • Sample Size: ISO 81060-2 typically requires a minimum of 85 subjects for clinical validation. The document does not explicitly state the exact sample size used in their study, but implies it met the requirements of the standard it followed.
  • Data Provenance: Not specified (e.g., country of origin). The study is described as a "comparative clinical study," which generally implies a prospective data collection for the purpose of the validation.

3. Number/Qualifications of Experts for Ground Truth

• Not Applicable / Not Specified: For a blood pressure monitor, the "ground truth" for blood pressure measurements is typically established using a reference standard like a mercury sphygmomanometer or an auscultatory method performed by trained observers, as outlined in ISO 81060-2. This is a measurement comparison, not an expert-based image interpretation or diagnosis that would require multiple reading experts in the AI sense.

4. Adjudication Method

• Not Applicable / Not Specified: Since this is a direct physiological measurement comparison, adjudication methods commonly seen in AI/image interpretation studies (e.g., 2+1, 3+1 consensus) are not relevant here. The ISO 81060-2 standard defines precise measurement protocols by trained observers for comparison.

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

• Not Applicable: This type of study is relevant for AI-assisted diagnostic aids where human readers' performance (e.g., accuracy, efficiency) is evaluated with and without AI. This device is a standalone measurement tool, not an AI diagnostic aid for human readers.

6. Standalone (Algorithm Only) Performance

• Implicitly Done: The "Performance Data" section explicitly states compliance with "IEC 80601-2-30" and "ISO 81060-2." These standards define the requirements for the automated (standalone) measurement of non-invasive blood pressure, requiring the device algorithm (oscillometric technique) to provide accurate pressure readings independently. The clinical study compares the device's automated readings against a reference standard.

7. Type of Ground Truth Used

• Reference Standard Measurement: The ground truth for blood pressure measurements was established using a mercury sphygmomanometer (or an equivalent valid reference method) during the comparative clinical study, as per the ISO 81060-2 standard. This is a direct, objective physiological measurement.

8. Sample Size for the Training Set

• Not Applicable: This is a traditional medical device (blood pressure monitor) that utilizes a deterministic oscillometric algorithm, not a machine learning or AI model that requires a "training set" in the context of deep learning. Its algorithm is based on established engineering principles for detecting pressure oscillations.

9. How Ground Truth for Training Set Was Established

• Not Applicable: As there is no "training set" for a machine learning model, this point is not relevant for this device.

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The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single-site, natural orifice laparoscopic-assisted transvaginal and transabdominal benign surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment.

The representative uses of the Anovo Surgical System are indicated for the following benign procedures:

• Total benign hysterectomy with salpingo-oophorectomy
• Total benign hysterectomy with salpingectomy
• Total benign hysterectomy
• Salpingectomy
• Oophorectomy
• Adnexectomy
• Ovarian cyst removal
• Ventral Hernia

The Anovo Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy.

The Anovo Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy.

The Anovo Instrument ARM Curved Scissors and the Anovo Instrument ARM Hook Electrode are intended for use with the Anovo Surgical System.

The Anovo Surgical System model 6Ne (6N enhanced) was the subject of the Premarket Notification K242157, which was cleared on October 21, 2024, for use based on the Anovo 6N (predicate) Indication for Use cleared at the time the Anovo 6Ne was submitted. A subsequent 510(k) clearance (K250591) addressed the addition of the Endoscope Arm as an off-the-shelf accessory.

The Anovo Surgical System Model 6N was the subject of the Premarket Notification K241907 for expanding the Indication for use to include transabdominal access and Ventral Hernia procedure, which was cleared on October 2, 2024.

The Instrument ARM Hook and Scissors were evaluated and found safe and effective for use with the Anovo model 6N (K243182) and with model 6Ne (K251056).

Under the scope of this submission, the Anovo Surgical System Model 6Ne, including Instrument ARM Curved Scissor and Hook Electrode, are the subject of labeling unification to include Ventral Hernia through transabdominal access.

The Anovo Surgical System model 6Ne (6N enhanced) is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMs during single site, natural orifice transvaginal and transabdominal laparoscopic-assisted benign surgical procedures.

The Anovo Surgical System Model 6Ne ("Subject Device") is an enhanced configuration of the Anovo Surgical System 6N ("Predicate Device"). The Anovo Surgical System Model 6Ne enhances the experience by incorporating Off-the-Shelf controllers to the Surgeon Console, including minor modifications in the Robotic Control Unit to support those controllers and allowing the use of an Off-the-Shelf Endoscope Arm as an optional accessory. Those modifications were performed mainly for commercialization and user experience and do not impact the key functionalities of the device. The system enhancements do not impact the system Instruments or accessories.

No changes were made to the Anovo Surgical System or its accessories for the scope of this submission. Additionally, there are no differences in the procedure for use of the system; the surgeon and surgical teams perform system set-up in the same manner as performed with the cleared Anovo 6Ne, where the only difference is transabdominal versus transvaginal access and the entry of the Instrument ARMs through these access ports, which is performed in the same manner as performed with the cleared Anovo 6N.

The provided FDA 510(k) clearance letter for the Anovo Surgical System describes a robotically-assisted surgical device, not an AI-powered diagnostic or treatment device. Therefore, the questions related to AI device performance metrics, such as ground truth establishment by experts, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.

The clearance focuses on demonstrating substantial equivalence to a predicate device (Anovo Surgical System model 6N) for an expanded indication for use (Ventral Hernia through transabdominal access) and the unification of labeling for existing instruments. The performance evaluation primarily involves non-clinical (cadaver) testing to confirm the system's compatibility, performance, and safety for the new indicated procedure.

Here's the breakdown of the information that can be extracted from the provided text, addressing the relevant aspects of the acceptance criteria and study, while noting the inapplicable questions:

Acceptance Criteria and Device Performance for Anovo Surgical System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't list specific quantitative acceptance criteria and corresponding reported device performance metrics in a typical tabular format as one would expect for an AI/diagnostic device. Instead, it describes a
qualitative acceptance criteria centered on the system's successful demonstration of compatibility, performance, and safety during Design Validation for the new indication.

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

• Test Set Description: Design validation was performed in female cadaver models.
• Sample Size: The exact number of cadaver models used is not specified in the provided text.
• Data Provenance: The text does not specify the country of origin of the cadaver models. The study was prospective in the sense of being a planned test to validate the changes.

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

• Not Applicable: This criterion relates to AI/diagnostic devices where expert consensus is used to label data. For a surgical system, "ground truth" is about the functional performance and safety observed during a surgical procedure simulation. The document mentions "trained physicians" are intended users, implying their involvement in the cadaver study, but does not specify their number or role in establishing a "ground truth" as it would be defined for an AI evaluation.

4. Adjudication Method for the Test Set

• Not Applicable: This criterion is for AI/diagnostic devices where multiple experts provide annotations, and a method (e.g., 2+1, 3+1) is used to resolve disagreements. For a surgical system validation, "adjudication" typically refers to the process of evaluating the successful completion of surgical tasks and safe operation, which would be part of the design validation protocol, but not in the sense of expert annotation adjudication.

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

• Not Applicable: An MRMC study is designed to assess how human reader performance (e.g., diagnostic accuracy) changes with or without AI assistance. This device is a surgical system, not a diagnostic AI. The study's purpose was to demonstrate the safe and effective performance of the surgical system itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

• Not Applicable: This criterion refers to the performance of an AI algorithm in isolation. The Anovo Surgical System is an instrument control system that assists human surgeons. Its function is inherently human-in-the-loop, so a "standalone" performance (without human interaction) is not relevant or possible for this type of device.

7. Type of Ground Truth Used

• Functional Performance and Safety Assessment: The "ground truth" in this context is the successful and safe execution of representative surgical procedures (Ventral Hernia Repair) in cadaver models. This is assessed against predefined specific requirements for "transabdominal clinical compatibility, performance, and safety." It's not based on expert consensus on image labels, pathology, or patient outcomes data in the traditional sense of a diagnostic study.

8. Sample Size for the Training Set

• Not Applicable: This device is a mechanical/robotic surgical system, not an AI model that requires a training set of data. The "training" for such a system would involve engineering design, prototyping, and iterative testing, not the machine learning concept of a training dataset.

9. How Ground Truth for the Training Set Was Established

• Not Applicable: As there is no "training set" in the machine learning sense, this question is not applicable. The design and development of the surgical system are based on engineering principles and regulatory requirements for medical devices.

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Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.

Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.

This document is an FDA 510(k) Clearance Letter for "Electrosurgical Pads." It demonstrates no AI/ML algorithm in its description, and therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI-powered device is not applicable.

The document primarily focuses on demonstrating substantial equivalence of the Electrosurgical Pads to a predicate device and reference devices through:

• Indications for Use comparison: Showing the subject device has the same intended use as the predicate and highly similar indications for use as reference devices.
• Technological Characteristics comparison: Detailing material composition, size, corded/non-corded options, patient weight applicability, and safety/performance standards met.
• Non-clinical performance testing: Listing compliance with relevant IEC and ISO standards for electrical safety, EMC, performance, and biocompatibility.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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The gi2000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform cutting and/or coagulation, in flexible endoscopic applications.

The gi2000 is an electrosurgical generator for use in flexible endoscopic clinical settings, employing high-frequency energies to carry out cutting and coagulation of tissue during gastrointestinal surgical procedures. This isolated output electrosurgical unit (ESU) includes all standard features commonly utilized in a broad spectrum of gastrointestinal surgical procedures, encompassing monopolar cutting, monopolar coagulation, and monopolar spray coagulation, along with bipolar coagulation.

The gi2000 consists of the high-frequency electrosurgical unit with control panel and an operating foot switch. The handpiece (electrodes) and dispersive pad (return electrode) are not included with the gi2000. Instead, device labeling lists optional pieces that have been validated with the device.

The provided text is a 510(k) clearance letter for an electrosurgical generator (gi2000). While it describes the device, its intended use, and generally mentions that performance testing was completed, it does not contain the specific acceptance criteria or detailed study results as typically found in a clinical study report or a more comprehensive summary of safety and effectiveness data.

The 510(k) summary states, "Performance testing on the gi2000 was completed by three methods," and then lists the types of studies: ex-vivo comparative study, accessory compatibility study, and in-vivo preclinical test. However, it only references internal document IDs (e.g., "40-0036-11 DS, Predicate Device Comparative Study Report, gi2000") rather than providing the data itself.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and device performance, sample sizes, expert qualifications, or multi-reader multi-case studies from the provided text. The document confirms that performance testing was done and demonstrated substantial equivalence, but it does not present the specific data points to fill out your requested table and study details.

To address your request, I would need a document that contains the actual results of these performance tests, including the quantitative acceptance criteria and the values measured for the gi2000.

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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters:
Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device. Certain catheters may incorporate a lumen for balloon inflation.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

Needle / Cannula (Introducer):
The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits.

The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle is then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided FDA 510(k) clearance letter and summary describe the Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer). The submission is a "Special 510(k)" primarily focused on removing a warning label related to unknown electromagnetic compatibility (EMC) with low-frequency emissions.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core of this Special 510(k) is the demonstration of electromagnetic compatibility, specifically concerning immunity to proximity magnetic fields, to justify the removal of a previous warning label.

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

• Sample Size: The document does not explicitly state a numerical sample size (e.g., "N=X devices were tested"). It refers to "representative external pulse generator equipment and the sample Temporary Pacing Electrode devices." This typically implies a limited number of devices/systems sufficient to represent the product line for EMC testing as per regulatory guidelines for in-vitro/bench testing.
• Data Provenance: The study was a bench (in-vitro) test performed to a recognized international standard (IEC 60601-1-2). There is no patient data involved, so there is no country of origin or retrospective/prospective distinction.

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

Not applicable. This was a bench-top engineering test evaluating electromagnetic compatibility against a defined international standard (IEC 60601-1-2). "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant here. The "ground truth" is the established test methodology and performance limits defined by the IEC standard.

4. Adjudication Method for the Test Set

Not applicable. As a bench test against objective standards, there is no expert adjudication process like those used in clinical studies for diagnostic accuracy. The results are objectively measured against the specified limits of the IEC standard.

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

Not applicable. This device is a passive pacing electrode catheter and introducer, not an AI-powered diagnostic or therapeutic tool with a human-in-the-loop component.

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

Not applicable. The device is a medical hardware component, not an algorithm. The testing focused on the physical and electrical compatibility of the hardware with relevant external equipment.

7. The Type of Ground Truth Used

The "ground truth" for this study is compliance with international consensus standards for electromagnetic compatibility, specifically IEC 60601-1-2 (Edition 4.1): 2020, with particular focus on Clause 8.11 and the methods specified in IEC 61000-4-39 (2017). This standard defines objective tests and acceptance limits for device performance under various electromagnetic conditions.

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set.

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The Anovo Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy.

The Anovo Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy.

The Anovo Instrument ARM Curved Scissors and the Anovo Instrument ARM Hook Electrode are intended for use with the Anovo Surgical System.

The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below.

The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo Surgical System are indicated for the following benign procedures:

• Total Benign Hysterectomy with Salpingo-Oophorectomy
• Total Benign Hysterectomy with Salpingectomy
• Total Benign Hysterectomy
• Salpingectomy
• Oophorectomy
• Adnexectomy
• Ovarian cyst removal

The Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode ("Subject Device") are optional instruments for the Anovo Surgical System.
The purpose of this submission is to update the product labeling of the Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode to include compatibility with the Anovo Surgical System Model 6Ne.
The Anovo Surgical System Model 6N and Model 6Ne are almost identical, with the main difference being in the user interface. Both models are endoscopic instrument control systems that are intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.
Both system's models comprise a Surgeon Console operated by a non-sterile surgeon, two sterile instruments (Instrument ARMS) actuated by the non-sterile, Robotic Control Unit (RCU). Both systems allow the physician to operate the Instrument ARMS from the Anovo Surgeon Console by manipulating the ARMS Controllers under visual guidance.

The provided FDA 510(k) clearance letter (K251056) for the Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode indicates that this submission is primarily for a labeling update to include compatibility with a new system model (Anovo Surgical System Model 6Ne), rather than a submission for a novel AI/software device requiring extensive performance studies typically associated with AI/ML-based medical devices.

Therefore, the information regarding acceptance criteria and performance study details (e.g., sample sizes, expert ground truth, MRMC studies) as requested in the prompt, are not explicitly present within this 510(k) summary letter. The letter focuses on demonstrating substantial equivalence based on the device being identical to the predicate in design and function, and that the compatibility with the new system model was validated.

However, I can extract the relevant information implied by the document and address the requested points to the best of my ability based on the provided text, while highlighting what is not present for this specific type of submission.

Device Background and Purpose of Submission (K251056):

The Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode are surgical instruments intended for tissue manipulation (cutting, dissecting, coagulating) using monopolar energy. They are used with the Anovo Surgical System, which is an endoscopic instrument control system for transvaginal benign surgical procedures.

The primary purpose of this specific 510(k) (K251056) is not to introduce a new device or a new AI/software component, but to update the product labeling of already cleared instruments (Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode, previously cleared under K243182) to include compatibility with a newer version of the Anovo Surgical System, Model 6Ne. The submitter states: "No changes were made to the Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode or any of the Anovo Surgical System Components for the scope of this submission."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the validation of compatibility and continued safety/performance with the new system model, rather than the initial performance validation of an AI algorithm or a novel surgical instrument's core functionalities.

Acceptance Criteria and Study for K251056 (Compatibility Validation):

Given the nature of this 510(k) (labeling update for system compatibility), the "acceptance criteria" revolve around demonstrating that the instruments perform as intended when used with the new system model (6Ne) and remain as safe and effective as with the predicate system. The study conducted appears to be a design validation focused on this compatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: "female cadaver models" (plural, indicating more than one, but no specific number is provided).
• Data Provenance: The study was conducted on "female cadaver models." No country of origin is specified for the cadavers themselves, but the submitter is based in Israel. The description indicates a prospective evaluation of compatibility.

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

• Not Applicable / Not Specified: This validation study is for compatibility of surgical instruments with an control system, not for an AI/ML diagnostic or image analysis device where "ground truth" typically involves expert annotations or diagnoses. The "ground truth" here is the direct observation of the instruments' functional performance and compatibility during the simulated surgical procedures in cadavers. While trained physicians are mentioned as users of the system for clinical use, their role in establishing ground truth for this specific validation study is not detailed, beyond their likely involvement in conducting and assessing the simulated procedures.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Specified: Given the nature of a cadaveric performance and compatibility study for surgical instruments, formal adjudication methods (like 2+1 or 3+1 used for reader studies in AI) are not typically employed or detailed in the publicly available summary for this type of submission. The successful meeting of "predefined specific requirements" implies an agreed-upon assessment.

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

• No, not for this submission. This is not an AI/ML diagnostic device requiring an MRMC study to assess human reader improvement with AI assistance. It's a re-clearance for hardware compatibility.

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

• No, not applicable. This is not an algorithm, but rather surgical instruments used with a control system, inherently requiring a human "in the loop" (the surgeon).

7. The Type of Ground Truth Used:

• Direct Observation and Performance Assessment: The ground truth for this compatibility study was based on the direct observation of the instruments' performance (cutting, dissecting, coagulating, and proper function within the system) in cadaveric models. This confirms whether the system and instruments work as intended and meet safety and performance specifications.

8. The Sample Size for the Training Set:

• Not Applicable: This is a hardware compatibility validation, not an AI/ML submission. Therefore, there is no "training set" in the context of machine learning. The instruments and system were likely developed and refined through extensive R&D and previous testing, but that's not a "training set" in the AI sense.

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

• Not Applicable: As there is no training set for an AI/ML model, this question does not apply.

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Electro Lube™ NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue sticking and eschar on electrosurgical instruments, including robotic assisted electrosurgical instruments.

Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to reduce sticking. It is intended to be used by professional practitioners of electrosurgery in clinical environments where electrosurgery is performed.

Electro Lube NXT is sterilized by irradiation and provided to the end user in an individual sterile barrier package with one bottle containing 4mL of the solution and one foam pad for application of the solution during use included in each pack. The foam pad includes an adhesive backing and barium filament strand of material for radiopacity.

The provided FDA 510(k) clearance letter for Electro Lube NXT does not contain the detailed information necessary to answer all sections of the request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, it lists criteria for various non-clinical tests but does not provide the reported device performance for these tests, nor does it describe a clinical study (like an MRMC study) or details about ground truth establishment, expert qualifications, or sample sizes for clinical data.

The document primarily focuses on non-clinical performance and substantial equivalence to a predicate device, which is typical for a 510(k) submission for this type of device (an electrosurgical accessory).

However, I can extract and infer some information based on the provided text.

Here's an attempt to answer the questions based only on the provided document. For many points, the answer will be "Information not provided in the document."

Acceptance Criteria and Device Performance Study for Electro Lube NXT

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

The document lists various acceptance criteria for non-clinical tests. However, it does not report specific quantitative device performance results against these criteria. Instead, it generally states that the "proposed device is as safe, as effective and performs at least as well as the legally marketed predicate device."

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

• Sample Size for Test Set: Information not provided. The tests described are laboratory/benchtop performance tests, not clinical studies involving patient data.
• Data Provenance (Country of origin, retrospective/prospective): Information not provided. These are non-clinical lab tests, so typical data provenance details like "country of origin" for 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

Information not provided. The "ground truth" for these performance tests would be established by the test protocols themselves and measured by laboratory equipment or validated methods, not primarily by expert consensus in a clinical image interpretation setting. For subjective evaluations (e.g., visual inspection for appearance, odor profile), the experts would be the lab personnel or qualified assessors, but their number and specific qualifications are not detailed.

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

Information not provided. Adjudication methods are typically used in clinical studies with human assessors (e.g., radiologists reviewing images) to resolve discrepancies. This is not applicable to the described non-clinical performance 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

No. An MRMC study was not done. The device is an electrosurgical accessory (a lubricant), not an AI-powered diagnostic imaging device. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.

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

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

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

For the non-clinical tests described, the "ground truth" would be established by:

• Standardized test methods and protocols (e.g., ASTM standards, ISO standards for biocompatibility).
• Quantitative measurements (e.g., weight loss, force measurements, temperature readings).
• Visual inspection against predefined specifications (e.g., clear and homogenous, no particulates).
• In-vitro or benchtop simulations (e.g., tissue models for adherence, eschar removal).

8. The sample size for the training set

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

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

Not applicable. No training set is used for this device.

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