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The Trabectome™ High Frequency Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.

The Trabectome™ High Frequency Generator/LP is a non-sterile, reusable electrosurgical generator. The device is designed to generate high frequency (radiofrequency "RF") high voltage and low amperage current. The device operates in either the monopolar or the bipolar mode. The device is available in two voltage models: 110 VAC or 220 VAC (for international use). The generator is activated through an input jack on the front panel. The activation can be via a footswitch or other single pole closure device with a compatible plug.

This document is a 510(k) Premarket Notification for a medical device called the Trabectome™ High Frequency Generator/LP. It is not a study that proves the device meets acceptance criteria derived from performance metrics. Instead, it is documentation submitted to the FDA to demonstrate substantial equivalence to a predicate device already on the market.

Therefore, most of the requested information (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.

Here's the relevant information that can be extracted:

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

• Not Applicable. This document establishes substantial equivalence to a predicate device, not performance against specific acceptance criteria. The primary "performance" characteristic discussed is the maximum power output, which is compared to the predicate device.

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

• Not Applicable. No test set or performance study is described. The submission is based on comparison to a predicate device and engineering documentation, not clinical or performance data from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No test set or ground truth determination by experts is mentioned in this submission.

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

• Not Applicable. No test set performance or adjudication 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. This device is an electrosurgical generator, not an AI or imaging device. No MRMC study was performed.

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

• Not Applicable. This device is an electrosurgical generator, not an algorithm. Standalone performance as described is not relevant.

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

• Not Applicable. No ground truth determination is mentioned in this substantial equivalence submission.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this is not an AI or machine learning device.

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

• Not Applicable. No training set or ground truth establishment is mentioned.

Summary of the Document's Purpose:

The provided document is a 510(k) Premarket Notification for the NeoMedix Corporation Trabectome™ High Frequency Generator/LP. Its core purpose is to demonstrate substantial equivalence to a previously cleared predicate device, the Aaron Medical Model 800 High Frequency Desiccator (K955681). The key arguments for equivalence are:

• Similar Indications for Use: Both are for electrosurgical applications.
• Similar Technology: Both operate in monopolar or bipolar mode at ~500 kHz.
• Design and Construction: Described as substantially equivalent.
• Difference Noted: The Trabectome™ has a lower maximum power output (6 watts) compared to the predicate device (30 watts), which is considered acceptable as it's intended for "low power microsurgical applications."

The FDA's letter confirms that based on the provided information, the device is considered substantially equivalent to a legally marketed predicate device. This is a regulatory clearance process, not a clinical study proving performance against specific acceptance criteria.

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The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.

The NMX-1000™ is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical tubing designed to operate in the bipolar model. The handpiece is ABS plastic and incorporates a stainless steel probe of low energy output control. The special production of the device model is supplied when connected to a compatible electrosurgical generator of the handpiece to standard irrigation and aspiration devices.

The provided text is a 510(k) Premarket Notification for the NeoMedix Corporation's NMX-1000™ electrosurgical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials with detailed acceptance criteria and performance data like those typically seen for AI/ML devices. Therefore, much of the requested information about acceptance criteria, study design, and performance metrics for a novel device is not available or applicable in this context.

However, I can extract the relevant information that is present in the document.

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

Since this is a 510(k) submission for a non-AI/ML device demonstrating substantial equivalence to a predicate, explicit "acceptance criteria" in the sense of predefined thresholds for diagnostic performance (e.g., sensitivity, specificity) for a novel AI algorithm are not provided. Instead, the device's "performance" is demonstrated by its equivalency to a predicate device and compliance with relevant safety standards.

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

Not applicable. This is not a study involving a "test set" of patient data for evaluating an algorithm's performance. The evaluations were engineering tests, biocompatibility studies, and comparisons to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for an AI/ML diagnostic device (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's safety and performance is based on engineering standards, material science, and regulatory compliance.

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

Not applicable. No "adjudication method" for interpreting data is mentioned as it's not a diagnostic study.

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 non-AI/ML electrosurgical device.

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

Not applicable. This is a non-AI/ML electrosurgical device.

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

The "ground truth" or basis for affirming the device's safety and effectiveness relies on:

• Compliance with recognized standards: IEC 60601-1, ANSI/AMI HF-18, ISO 10993-1.
• Engineering testing: Hydroblister testing for integrity, tip bend resistance.
• Material history: "established history of safe use in similar medical devices."
• Substantial equivalence: Direct comparison to legally marketed predicate devices (NeoMedix MicroSurgical Bipolar Handpiece (K024304) and Storz Maumenee Goniotomy Knife Cannula).

8. The sample size for the training set

Not applicable. This is a non-AI/ML electrosurgical device. There is no "training set."

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

Not applicable. This is a non-AI/ML electrosurgical device.

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The NeoMedix SupraFlow Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired. The device is not indicated for liposuction use.

The Console contains a roller pump to provide aspiration from the surgical site and a pinch valve to initiate the flow of irrigation fluid simultaneously with the optional foot switch con switch con be used to activate both actions.

This document describes the NeoMedix SupraFlow Console Aspiration Pump (K040239).

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics and their targets (e.g., flow rate must be X L/min +/- Y%). Instead, it states that "Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols."

The "performance" discussed is primarily related to safety and functionality, comparing it to predicate devices.

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

The 510(k) summary does not provide information regarding a "test set" in the context of clinical data, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are based on engineering and safety testing.

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

This information is not applicable or provided in the context of this 510(k) submission, as it focuses on device functionality and safety rather than a clinical study requiring expert ground truth for, e.g., diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable or provided for the reasons stated above.

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

No, an MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is typically for evaluating the impact of AI or new diagnostic tools on human reader performance, which is not relevant for an aspiration pump.

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

No, a standalone algorithm performance study was not performed or described. This device is a mechanical aspiration pump, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering specifications and test protocols: The device must meet its designed performance specifications (e.g., flow rate, pressure, safety features).
• Compliance with consensus standards: Specifically IEC 60601-1 for electrical safety.
• Comparison to predicate devices: Functionality and aspiration capabilities are shown to be similar to legally marketed predicate devices.

There is no mention of pathology, outcomes data, or expert consensus in the clinical sense for establishing "ground truth" for the device's technical performance.

8. The Sample Size for the Training Set

This information is not applicable or provided. The device is a physical pump, not an AI algorithm that requires a "training set."

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

This information is not applicable or provided as there is no "training set" for this device.

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The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.

The Handpiece is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical grade tubing with standard luer fittings. The Handpiece is ABS plastic and incorporates a stainless steel probe designed to operate in the bipolar mode when connected to any compatible bipolar electrosurgical generator capable of low energy output control. The irrigation and aspiration sets provide for connection of the handpiece to irrigation and aspiration devices.

The provided text describes a 510(k) premarket notification for a medical device, the NeoMedix MicroSurgical Bipolar Handpiece. However, it does not include a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/algorithm-based device would.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with established standards for safety.

Therefore, for aspects like "AI/algorithm performance," "sample size for test/training sets," "expert ground truth establishment," or "MRMC studies," the information is not present because this is a traditional medical device submission, not an AI/software device submission.

Here's an analysis of the available information:

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

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

• Not applicable / Not provided. This type of information (sample size, data provenance) is typically for studies involving data analysis or algorithm performance, which is not the primary focus of this 510(k) submission. The "testing" here refers to engineering and safety tests rather than clinical data sets.

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 relevant for diagnostic or AI-driven devices. This submission relies on engineering standards and physical testing.

4. Adjudication method for the test set

• Not applicable / Not provided. Adjudication methods are relevant for expert review processes, which are not detailed here.

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, as this is not an AI-assisted diagnostic or interpretive device.

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

• No. This device is a surgical handpiece, not an algorithm.

7. The type of ground truth used

• Physical/Engineering Standards and Biocompatibility Testing. The "ground truth" for this device's performance is compliance with established international and national standards for material safety (biocompatibility), electrical safety, and mechanical integrity.

8. The sample size for the training set

• Not applicable / Not provided. This refers to training data for algorithms, which is not relevant to this device.

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

• Not applicable / Not provided. This refers to ground truth for training data for algorithms, which is not relevant to this device.

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