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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)

Based on the provided document, the following information is NOT available as the submission does not involve an AI or human reader performance study:

2. Sample sizes used for the test set and the data provenance: Not applicable to this type of non-clinical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective measurements against engineering and safety standards.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, "ground truth" refers to compliance with established industry standards (e.g., IEC, ISO, ASTM) and internal performance specifications.
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

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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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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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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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The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.

The EHL is a compact, table-top medical device designed for the fragmentation of biliary calculi. It operates by generating high-voltage electric pulses, which are transmitted through a compatible disposable EHL probe (sold separately) that is inserted into the biliary tract via an endoscope. The device features two operational modes: single pulse and continuous pulse. These electric pulses create hydraulic shock waves in a saline medium, causing fragmentation of biliary stones into smaller pieces that can either be naturally passed or removed endoscopically.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets such criteria.

The document is a 510(k) summary for an Electrohydraulic Lithotriptor (TCS-B3-II) and focuses on demonstrating substantial equivalence to a predicate device (EL27-Compact). It outlines various performance and safety tests conducted but does not provide specific acceptance criteria values or detailed study results in the format requested.

The "Performance Data" section mentions "Stone Fragmentation Test," "Shockwave Pressure Attenuation Test," "Acoustic Characterization Test," "Electrical Safety and Electromagnetic Compatibility (EMC) Testing," and "Software Verification and Validation." However, it only describes what these tests validated or complied with (e.g., "validated the system's ability to generate consistent high-voltage pulses," "tested for compliance with IEC 61846," "tested for compliance with IEC 60601-1"), rather than presenting quantitative acceptance criteria and the device's reported performance against them.

Therefore, I cannot populate the table or answer the specific questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details for any specific acceptance criteria from this text.

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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).

Electronic blood pressure monitor is a Noninvasive Blood Pressure Measurement System that is intended to measure blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record may be revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The electronic blood pressure monitor is small, portable and used in home or medical facilities environment. It consists of two parts: main unit and cuffs. The electronic blood pressure monitor is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

The provided text describes the acceptance criteria and the study that proves the device (Electronic Blood Pressure Monitor models D6606US, D6607US) meets these criteria, primarily by demonstrating substantial equivalence to a predicate device (HTD6602US, K223170).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards and are met by the device. The reported device performance is that it meets these standards.

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

The document states that a clinical study was performed on the predicate device (HTD6602US, K223170). The results of this study were transferred to the subject device (D6606US, D6607US) because the subject device has the same specifications, intended use, method of measurement, measurement type, critical components (e.g., air pump, sensor, cuff), and algorithm as the predicate device.

• Sample Size for Clinical Accuracy Testing: The document does not explicitly state the sample size. It only refers to "all the relevant activities were performed by designate individual(s)" as per ISO 81060-2. ISO 81060-2 specifies requirements for clinical investigation of automated non-invasive sphygmomanometers, which includes specific sample size requirements (e.g., typically at least 85 subjects with a distribution across blood pressure ranges). However, the exact number is not provided in this submission summary.
• Data Provenance: The clinical study data originates from the testing done for the predicate device K223170. The country of origin and whether it was retrospective or prospective are not specified in this document, but "clinical investigation" usually implies a prospective study.

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

The document mentions that for the clinical accuracy testing (performed on the predicate device), "all the relevant activities were performed by designate individual(s)". It does not specify the number of experts or their qualifications for establishing ground truth, but implicitly, highly qualified medical professionals/technicians are required to perform and verify measurements according to ISO 81060-2.

4. Adjudication method for the test set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For blood pressure measurement studies following ISO 81060-2, ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, with specific protocols for resolving discrepancies, although these details are not provided 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 MRMC Study: This device is an Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done as it is irrelevant for this type of device.

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

• Yes, a standalone performance assessment was done (implicitly). The primary study cited is the clinical accuracy testing of the predicate device against ISO 81060-2. This standard evaluates the accuracy of the automated device (algorithm only) compared to a reference measurement performed by trained observers, effectively assessing its standalone performance. The results of this standalone performance were deemed acceptable for the predicate and transferred to the subject device.

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

The ground truth for the clinical accuracy testing (following ISO 81060-2) is established by simultaneous or sequential measurements using a standardized reference method (e.g., mercury sphygmomanometer with trained observers) against which the automated device's readings are compared. This is a form of expert measurement/consensus in a controlled clinical setting.

8. The sample size for the training set

This information is not applicable/provided. The device is an Electronic Blood Pressure Monitor based on oscillometric measurement, not a machine learning or AI device that typically requires a "training set" in the conventional sense. The development of its algorithm would involve engineering and calibration, not statistical training on a dataset of labeled cases in the AI context.

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

This information is not applicable/provided for the same reasons as point 8.

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The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.

Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.

The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.

Here's an analysis of the acceptance criteria and study information for the Electronic Apex Locator (Alpha Apex I), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size used for the accuracy testing test set (e.g., number of teeth, number of measurements). It only mentions that "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted."

The data provenance is not specified. It is unclear if the data was collected retrospectively or prospectively, or its country of origin.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the performance testing.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or performed. The device is an electronic apex locator, which is typically used directly by a single dental practitioner, not for multi-reader interpretation of images or data.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Accuracy Testing" section states, "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted and demonstrated that the subject device meets the requirement of ±0.5mm." This indicates the algorithm's performance was evaluated independently.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used for the accuracy measurements (e.g., direct visual measurement through transparent tooth, X-ray confirmation, histological analysis). It only refers to "internal technical requirements" for verifying accuracy.

8. Sample Size for the Training Set

The document does not provide information on the sample size for any training set. This is likely because the Electronic Apex Locator is a hardware device based on electrical impedance principles, and while it contains a microprocessor and software, the core "measurement" algorithm is typically determined through engineering design and calibration rather than machine learning training on a large dataset in the way a diagnostic AI would be. The software validation (Alpha Apex I.1.0.0) focuses on general software development life cycle processes, not necessarily on a training and testing paradigm for an AI model.

9. How Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or implied for a machine learning model, there is no information on how its ground truth would have been established. The device relies on physical principles and calibrated measurements rather than a trained AI model in the conventional sense.

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The Electrode Pad is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Electrode Pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.

Electrode Pad is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate).

Electrode Pad is non-sterile and intended for single adult patient multiple application use. The electrode pad has various shapes and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Electrode Pad (K241512), focusing on the requested information.

It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI-powered medical device. Therefore, much of the requested information, particularly concerning AI device performance metrics, human reader studies, and detailed ground truth establishment for a test or training set, is not present in this type of document because the device is a simple "Electrode Pad" and not an AI-enabled diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes performance testing for a non-AI hardware device (an electrode pad). Therefore, the concept of a "test set" in the context of machine learning, with associated data provenance, is not applicable here. The tests conducted are non-clinical, laboratory-based tests on the physical device components and batches of manufactured electrodes. The document does not specify general "sample sizes" for all tests, but implies testing was sufficient to meet standard requirements. The provenance of the data is from the manufacturer's internal testing.

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

Not applicable. As this is a physical medical device, not an AI diagnostic tool, there is no "ground truth" derived from expert interpretation for a test set. Acceptance is based on meeting technical specifications and international standards.

4. Adjudication Method for the Test Set

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

Not applicable. This device is an electrode pad, not an AI system. No MRMC study was conducted.

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

Not applicable. This is a physical electrode pad, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:

• International Standards: Adherence to standards like ISO 10993 series for biocompatibility, ASTM F1980-16 for accelerated aging, and AAMI/ANSI ES 60601-1 / IEC 60601-2-2 for electrical safety and impedance.
• Predicate Device Specifications: Demonstrating performance within ranges or equivalent to a legally marketed predicate device (K182111 DL Adhesive Electrode) for key parameters such as impedance and adhesion.
• Design Specifications: The device met its own design specifications.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device. The concept of a "training set" is irrelevant in this context.

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

Not applicable, as this is not an AI/machine learning device and therefore has no "training set" or corresponding ground truth establishment.

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The Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The ES-100 and ES-300 Electrosurgical Generator are advanced high-frequency surgical devices designed to provide versatility and safety in various surgical procedures. Both models offer a range of operating modes, including monopolar electrosurgical excision modes, monopolar electrocoagulation modes, and bipolar modes, catering to the diverse needs of surgeons. The maximum output power of the ES-100 is 100 W, while the ES-300 offers increased output power of up to 300 W, providing surgeons with enhanced capabilities for cutting and coagulation in various surgical procedures. Both models are equipped with manual and foot switch controls, allowing for seamless operation during surgeries. They feature volume control for adjusting the device's audio output, memory functions for storing recent settings, and built-in return electrode monitor systems for real-time safety monitoring.

This document is a 510(k) summary for an Electrosurgical Generator, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, and performance metrics for an AI/ML powered device cannot be extracted from this document.

The document describes the regulatory submission for electrosurgical generators (ES-100 and ES-300 models) and compares them to a predicate device (Bovie IDS-310 High Frequency Electrosurgical Generator). The core of the submission is to demonstrate "substantial equivalence" to the predicate device, not to prove performance against specific acceptance criteria for an AI/ML algorithm.

Here's how each of your requested points relates to the provided document:

1. A table of acceptance criteria and the reported device performance: This document does not specify "acceptance criteria" in the context of an AI/ML study. Instead, it presents a comparison table of technical characteristics between the subject device and the predicate device (pages 7-8). The "performance" mentioned refers to electrical safety, electromagnetic compatibility, output performance, and thermal damage characteristics of the electrosurgical unit itself, not an AI/ML algorithm's diagnostic performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document is about hardware medical devices and their electrical/thermal performance, not an AI/ML algorithm that processes 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): Not applicable. "Ground truth" in the context of expert consensus for AI/ML validation is not a component of this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for electrosurgical generators would be physical measurements of electrical output and thermal effects, verified through accredited testing, not expert consensus on medical images or patient outcomes data.

8. The sample size for the training set: Not applicable. This is for an electrosurgical hardware device, not an AI/ML model.

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

In summary, the provided document is a 510(k) premarket notification for electrosurgical generators, demonstrating substantial equivalence to a predicate device through non-clinical testing (electrical safety, EMC, bench testing for output performance, and preclinical thermal damage assessment). It does not contain any information related to AI/ML device validation.

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The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.

The Electroporation System consists of Electroporation Power Generator, Electroporation Trigger Probe, Electroporation Standard Probe, Electroporation Fixator support and Foot Switch. The single-use Electroporation Trigger Probe with EO sterilization is the same as Electroporation Standard Probe and Electroporation Fixator support. The Electroporation Power Generator and Foot Switch are non-sterile and reusable. With the Electroporation System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts, pulse width, pulse frequency and the distance between probes. Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot switch, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

The provided text is an FDA 510(k) premarket notification for a medical device, the "Electroporation System (N3000)". It outlines the device description, indications for use, comparison to a predicate device, and various tests performed to demonstrate substantial equivalence.

However, the document does not contain information regarding acceptance criteria and a study to prove the device meets these criteria in the context of AI/ML device performance metrics (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance).

The document primarily focuses on:

• Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601 series.
• Biocompatibility Testing: Compliance with ISO 10993-1.
• Sterilization & Shelf Life: Compliance with ISO 11135 and ISO 11607.
• Software Validation: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Functions.
• Animal Testing: An in-vivo animal study on porcine models to compare ablation volume and ECG trigger mode, and potential thermal ablation effect, between the subject and predicate devices.

The "Animal testing" section states: "The results show that the safety and efficacy of the tested articles are similar to those of the control articles." This is the closest the document comes to a performance claim, but it's not quantitative or related to AI/ML acceptance criteria.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide information about the specific types of studies listed (MRMC, standalone algorithm performance, AI assistance effect size, etc.) because these details are not present in the given document.

The document clearly states: "Clinical studies were not required to demonstrate the substantial equivalence of the Electroporation System and the predicated device." This further indicates that no human clinical performance study, often where metrics like sensitivity/specificity and MRMC studies would be conducted for AI/ML devices, was performed or presented in this 510(k).

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