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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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Electrodes Handpieces (VCT, RFTV, BMDT) are indicated for coagulation and ablation of tissue when used in conjunction with Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).

Electrodes Handpieces (VCT, RFTV, BMDT) are sterile, single-use electrosurgical electordes intended to be use in conjunction with with compatible radio frequency generator, mainly Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).

Electrodes Handpieces (VCT, RFTV, BMDT) consist of electrode tip, insulation part, handle.

Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (VCT, RFTV, BMDT), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.

This document describes a 510(k) premarket notification for Electrode Handpieces (VCT, RFTV, BMDT) and does not contain information about the acceptance criteria or a study proving that an AI/ML device meets those criteria. The provided text is for a traditional medical device (electrosurgical electrodes) and focuses on substantial equivalence to a predicate device through non-clinical performance data.

Therefore, I cannot provide a response with the requested information about acceptance criteria and a study for an AI/ML device from this document.

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The Electrode Market Disposable Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.

Electrode Market Disposable Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single use. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.

This document describes the FDA's 510(k) clearance for Electrode Market Disposable Surface Electrodes (K211839). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing studies to prove the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample sizes for test sets, data provenance, number of experts, qualifications of experts, and adjudication methods for establishing ground truth for test sets.
• Information regarding a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Information regarding a standalone algorithm-only performance study.
• The type of ground truth used (e.g., pathology, outcomes data) in the context of AI/ML.
• Sample size for training sets and how ground truth for training sets was established.

However, the document does contain information about the non-clinical tests performed to demonstrate the safety and effectiveness of the device as a medical electrode. This can be interpreted as the studies done to meet the acceptance criteria for a medical electrode.

Here's a summary of what's provided related to device performance and testing:

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

The document doesn't provide a table of acceptance criteria in the explicit format requested for AI/ML performance metrics. Instead, it refers to compliance with established standards for medical electrodes. The "performance" is demonstrated by meeting these standards.

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

The document does not specify sample sizes for the tests mentioned (Biocompatibility, Electrical Property, Shelf-life, Electrical Safety), nor does it describe data provenance in terms of country of origin or whether the studies were retrospective or prospective. These tests are typically laboratory-based and performed on representative samples of the manufactured device.

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. The tests performed are engineering and biological evaluations, not diagnostic interpretations requiring expert consensus for ground truth.

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

Not applicable. Adjudication methods are relevant for human-in-the-loop diagnostic studies, which this is not.

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 a disposable surface electrode, not an AI diagnostic tool.

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

Not applicable. This device is a disposable surface electrode, not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the requirements and measurement methods specified in the cited international and national standards (ISO, AAMI/ANSI, ASTM, IEC). For example, a successful biocompatibility test means the material does not induce a harmful biological response above a certain threshold as defined by the standard.

8. The sample size for the training set

Not applicable. There is no AI model or training set described.

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

Not applicable. There is no AI model or training set described.

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Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.

Electrodes Handpieces (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999).

Electrodes Handpieces (BT, JET) consist of electrode tip, insulation part, handle.

Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (BT, JET), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.

This document (K193355/S002) is not for an AI/ML medical device, but rather for "Electrode Handpieces (BT, JET)" which are electrosurgical electrodes used for coagulation and ablation of soft tissue. Therefore, the questions related to AI/ML device acceptance criteria, study details, and human-in-the-loop performance are not applicable.

However, I can extract the acceptance criteria and study details that were performed for this specific medical device from the provided text.

Here's a breakdown of the information found, specifically addressing the device's performance data and acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions, as this is not an AI/ML device, the following are not applicable or not mentioned in the document:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm. The "test sets" here refer to specific physical samples or experimental setups for the non-clinical tests (e.g., pig tissue for thermal effect, device components for biocompatibility). Specific numbers for these are generally not detailed in a 510(k) summary beyond the fact that testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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: For the non-clinical tests (e.g., thermal effect), the "ground truth" is derived from direct measurements, observations, and histological analysis of the treated biological tissue and physical properties of the device. For other tests like biocompatibility and sterility, it's adherence to international standards and validated methods.
8. The sample size for the training set: Not applicable (no AI/ML algorithm requiring a training set).
9. How the ground truth for the training set was established: Not applicable.

Additional Information from the document:

• No clinical studies were considered for this submission. This explicitly states that the substantial equivalence determination was based solely on non-clinical performance data and technological comparisons.

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ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.

ELECTRODES PAD transmit electrical current to patient skin, the electrical current is first transmitted via the snap button or lead wire then transmitted to the conductive hydrogel which is adhered to patient skin. ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only. And the PAD is designed for single-patient and multiple application use. The leadwire type electrode and snap type electrode both have six basic components. Both models are composed of an insulation backing layer, a double sides adhesive tape, conducting film, hydrogel and plastic film. The construction different between both is leadwire and snap.

The provided document is a 510(k) Pre-market Notification for the "ELECTRODES PAD" device. It describes the device, its intended use, and its comparison to predicate devices, along with performance data.

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

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 specific sample sizes used for the non-clinical tests (biocompatibility, adhesion, dispersion, shelf life, electrical safety). The nature of these tests (e.g., in-vitro for cytotoxicity, potentially animal or human for irritation/sensitization, accelerated aging for shelf life) implies a controlled testing environment, but details are not provided. The data provenance is derived from the performance testing conducted by the manufacturer, Shenzhen Bestpad Technology Development Co., Ltd. The document does not specify country of origin for the data beyond the manufacturer's location in Shenzhen, China. These studies are retrospective in the sense that they are conducted on manufactured samples for regulatory submission rather than as a prospective clinical trial.

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

This information is not applicable/not provided in the context of this 510(k) submission. The performance testing described (biocompatibility, electrical impedance, adhesion, shelf life, etc.) are objective, laboratory-based tests. They rely on established industry standards and test methods (e.g., ISO 10993, AAMI EC 12, IEC 60601-1, ASTM F1980) rather than expert consensus or ground truth derived from expert review of subjective data. There is no mention of human experts evaluating results for these specific performance criteria.

4. Adjudication Method for the Test Set

This is not applicable/not provided. As the acceptance criteria are based on objective, quantifiable measures from laboratory testing (e.g., numerical thresholds for impedance, time duration for adhesion, pass/fail for biocompatibility), there is no need for an adjudication method by human experts. The results are typically compared directly against the predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an "ELECTRODES PAD," a passive medical device intended to transmit electrical current. It does not involve any artificial intelligence (AI) or machine learning components, nor does it require human readers to interpret output from the device. Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant to this submission.

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

This is not applicable. As stated above, the device is a passive electrical electrode pad and does not contain any algorithms or AI components.

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

The "ground truth" for the performance criteria in this submission is the objective outcome of standardized laboratory tests and compliance with recognized industry standards. For instance:

• For biocompatibility, the ground truth is the absence of toxic effects, irritation, or sensitization as defined by ISO 10993.
• For electrical impedance, the ground truth is a reading below a specified ohmic value (< 300 ohms).
• For adhesion, the ground truth is maintaining adhesion for a defined duration and number of uses according to AAMI EC 12.
• For shelf life, the ground truth is maintaining material properties and performance after accelerated aging or real-time studies, as per relevant FDA guidance and ASTM F1980.

There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for these technical performance aspects.

8. The Sample Size for the Training Set

This is not applicable. The device is not an algorithm-based or AI-driven device, so there is no "training set" in the context of machine learning. The device's performance is based on its physical and electrical properties, tested through non-clinical methods.

9. How the Ground Truth for the Training Set was established

This is not applicable for the same reason as point 8. There is no training set for this type of device.

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The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.

The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient's skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode.

The provided document is a 510(k) summary for medical electrodes, not an AI/ML device. Therefore, it does not contain the information requested in points 2-9 regarding AI/ML model performance, training, and validation.

However, I can extract the acceptance criteria and reported device performance for the physical electrodes as presented in the "Test Summary" and "Comparison to predicate device" sections.

Acceptance Criteria and Reported Device Performance

Study Details (for physical device, not AI/ML):

The document describes a 510(k) submission, which demonstrates "substantial equivalence" to a legally marketed predicate device, rather than a clinical study proving new performance. The "Test Summary" indicates that safety and performance were evaluated by "lab bench testing."

• Sample size used for the test set and the data provenance: Not specified in terms of sample size for the tests, but the data would be from lab bench testing (likely within China, given the company's location). This is not retrospective or prospective in the sense of a clinical trial; it's product testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical/electrical tests with objective measurements, not judgment-based assessments requiring experts for ground truth.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device (electrodes), not an AI/ML diagnostic or assistive tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Physical measurements and adherence to specified performance standards (e.g., ISO 10993, IEC 60601-1, specific impedance/strength values).
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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Electrodes with silver conductive as Glove style, Wristbands Style, Wrist sleeve, Elbow Pads Style and Knee Pads Style, Elbow Sleeve, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.

Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.

This document is a 510(k) Summary for a medical device (Electrodes with silver conductive) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, reader studies, and sample sizes for training and test sets is not available in this type of regulatory submission.

The document primarily relies on bench testing and a comparison of technical specifications to a previously cleared predicate device to assert safety and effectiveness.

Here's the information that can be extracted or inferred from the provided text, along with an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, "acceptance criteria" predominantly revolve around demonstrating substantial equivalence to a predicate device, as well as meeting basic biocompatibility standards and electrical resistance specifications. The performance is reported in terms of these comparisons.

Regarding the specific questions you asked for deeper study details:

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/Not provided: This document relies on bench testing and comparison to a predicate device, not a large-scale clinical test set for performance evaluation in the way an AI/software device would. The "test summary" only mentions "Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards." These would involve in vitro (cell culture) and potentially in vivo (animal, not human) tests, but not a "test set" of human data in the context of device performance as you might expect for an AI algorithm. The provenance would be the lab where these biocompatibility tests were conducted.

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/Not provided: There is no "ground truth" derived from expert consensus on patient data described, as this is a physical device (electrodes) and not an AI or diagnostic tool requiring such expert review of images or clinical outcomes.

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

• Not applicable/Not provided: See explanation for #3.

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

• Not applicable/Not provided: This device is physical conductive electrodes, not an AI software. Therefore, MRMC studies are irrelevant here.

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

• Not applicable/Not provided: This is not an algorithm. Bench tests were done to evaluate electrical properties and biocompatibility.

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

• Not applicable/Not provided: For the physical and chemical properties assessed (e.g., impedance, biocompatibility), the "ground truth" is established by laboratory measurement standards (e.g., resistance meters, cell viability assays, irritation scores) rather than clinical expert consensus or pathology data.

8. The sample size for the training set

• Not applicable/Not provided: There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided: See explanation for #8.

Summary regarding the nature of this submission:

This document is a 510(k) Pre-market Notification, which primarily aims to demonstrate substantial equivalence to a predicate device already legally marketed. For devices like these electrodes, this often means showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "study" here is not a clinical performance trial in the sense of evaluating diagnostic accuracy or clinical outcomes, but rather a series of bench tests (e.g., impedance, physical dimensions) and biocompatibility tests to ensure the device performs as expected and is safe for contact with the human body, compared against established standards and the predicate device's performance.

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The Urinary Incontinence Probe, model PR-51 Vaginal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are the light weight cylinder consisting of two independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a handle for comfort positioning in vaginal/anal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The probe is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method as recommended in user manual.

To fit with different type of device connection, the lead wire of device was provided with three different type of wire connection terminals, 2mm pigtail, 3.5mm femelle and 2.35 mm femelle. Either of the PR-51 Vaginal Probe & PR-52 Anal Probe can be connected to any one of three connection terminals.

The provided document describes a 510(k) premarket notification for an "Electrode for Urinary Incontinence" (Models PR-51, PR-52). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study with acceptance criteria.

Therefore, many sections of your request related to acceptance criteria, sample sizes, ground truth, expert adjudication, and clinical study outcomes cannot be directly extracted from this document, as these types of studies were explicitly stated as "Not applicable" (# 9 Brief discussion of clinical tests: Not applicable).

The document primarily addresses non-clinical performance and biological evaluation.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. No specific acceptance criteria (e.g., in terms of clinical efficacy, sensitivity, specificity, accuracy) or reported performance metrics are listed because no clinical performance study was conducted or required for this 510(k) submission. The submission focuses on substantial equivalence based on technological characteristics and non-clinical testing.

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/Not provided. No clinical test set. The non-clinical tests (biological evaluation and standards compliance) do not typically refer to "test sets" in the same way clinical studies do. The manufacturer is Guangzhou Finecure Medical Equipment Co., Ltd. from China.

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/Not provided. No clinical test set requiring expert ground truth.

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

Not applicable/Not provided. No clinical test set requiring adjudication.

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 for urinary incontinence, not an AI diagnostic imaging device. No MRMC study was conducted or is relevant.

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

Not applicable. This device is a medical electrode, not a software algorithm.

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

Not applicable. For the non-clinical tests, the "ground truth" would be compliance with the standards referenced (e.g., biocompatibility testing for ISO 10993).

8. The sample size for the training set

Not applicable/Not provided. No clinical study was conducted.

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

Not applicable/Not provided. No clinical study was conducted.

Summary of what the document does provide regarding device performance and acceptance:

The device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Everyway Incontinence Stimulation Electrode, K122194) and compliance with specific non-clinical standards.

Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission strategy):

Study Proving Device Meets Acceptance Criteria:

The "study" in this context refers to the non-clinical tests and analysis performed to demonstrate substantial equivalence and safety/effectiveness.

• Non-Clinical Testing: The document explicitly states that the "Electrode for Urinary Incontinence conforms to the following standards:" and then lists the three ISO 10993 standards mentioned above. This indicates that appropriate biocompatibility testing was performed and passed, leading to compliance with these standards.
• Comparison to Predicate Device: The 510(k) submission itself is a "study" of comparison, wherein the manufacturer presents arguments and data (including the declaration of compliance with standards) to demonstrate that their device is "substantially equivalent" to an already cleared predicate device. The FDA's review and clearance (K140265) indicate that they agreed with this assessment.

In conclusion, this regulatory document focuses on establishing substantial equivalence for market clearance, rather than reporting on a clinical effectiveness study with defined acceptance criteria for efficacy. The "acceptance criteria" are compliance with relevant safety standards (biocompatibility) and demonstration of similar technological characteristics and intended use as an existing cleared device.

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The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.

This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.

This 510(k) submission (K130489) is for a design and labeling change to an existing device, the PRECISION Endoscopic Infrared Coagulator™ with SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE. The submission explicitly states that there are no technology differences between the submission device and its predicate devices, and no changes to the intended use or indications for use.

Therefore, the study performed is focused on demonstrating that the design changes do not affect the safety and effectiveness of the device, rather than proving performance against new acceptance criteria for a novel technology.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a design change with no technological differences or changes to intended use, the acceptance criteria are implicitly that the device continues to meet the safety and effectiveness profile of the predicate devices. The reported performance is verification that these standards are maintained.

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

The document does not specify a quantitative sample size for the "bench testing" performed. It generally states that "Verification testing results for the design changes were completed and all tests passed."

• Sample Size: Not explicitly stated (likely refers to a number of test articles/units for bench testing).
• Data Provenance: The testing was "Bench testing," implying it was conducted in a laboratory or engineering setting by the manufacturer (Optim LLC in Sturbridge, MA). It is retrospective in the sense that it's verifying changes to an existing design, not gathering new clinical data on patients.

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

This type of information is not applicable to this 510(k) submission.

• This submission is not for an AI/ML device, diagnostic device, or a device that requires human interpretation of outputs to establish ground truth.
• The "verification testing" described is bench testing, which assesses engineering and functional performance against defined specifications, not against expert-established ground truth related to clinical outcomes or interpretations.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above. There's no interpretive test set requiring adjudication.

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 infrared coagulator, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or image interpretation.

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

Not applicable. This device does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is typically defined by engineering specifications, established performance parameters of the predicate device, and compliance with relevant consensus standards. For example, ground truth for power output might be a specific wattage as measured by calibrated equipment, or ground truth for light guide flexibility might be its ability to withstand a certain bend radius without damage. The document indicates verification was against the safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The Electrode Arrays Cap is intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.

The Electrode Array Cap comprises an electrode placement system for positioning electrodes. The density of electrodes will vary, but in general will conform to the 10-20 to 5-5 positioning system (Oostenveld & Praamstra, 2005). The electrode will be compatible with all standard AC/DC EEG amplifiers The Electrode Array Cap will consist of an elastic can, electrode holders, sintered Ag/AgCl electrodes, and shielded wires. The Electrode Array Cap will fit all head shapes and will be comfortable to wear. Shielded wires will terminate into a standardized connector designed. Separate shielded cables, tailored to each amplifier system, will mate with the standardized cap connector. Located in each connector will be a passive memory chip that will read out the serial number and other device information.

The provided text is a 510(k) summary for a medical device called "Electrode Array Cap." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing direct acceptance criteria and performance against those criteria in the way a novel algorithmic device would.

Therefore, the study described does not involve AI, human-in-the-loop performance, or complex ground truth establishment as it would for an algorithm. Instead, it relies on demonstrating that the new device has "the same technological characteristics" and "intended use" as already approved devices.

Here's an analysis based on the provided text, addressing your questions to the extent possible given the nature of the document:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

Since this is a 510(k) for a physical medical device (an electrode cap) demonstrating substantial equivalence, the "acceptance criteria" are primarily that the device is as safe and effective as its predicate devices, based on having similar technological characteristics and intended use. Performance is implicitly accepted if these similarities are established.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The provided document describes a "510(k) Summary," which is an executive summary of a submission to the FDA seeking clearance for a medical device based on substantial equivalence to a predicate device already on the market. It is not a clinical study report in the traditional sense, especially not for an AI/algorithmic device. Therefore, many of your questions related to algorithmic performance metrics (like sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's an attempt to address the questions based on the information available and the nature of a 510(k) for a physical, non-AI device:

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

   • See the table above. The "acceptance criteria" for a 510(k) of this nature are that the device is substantially equivalent to legally marketed predicate devices in terms of intended use and technological characteristics, and that it does not raise new questions of safety or effectiveness.

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 document describes a physical medical device (an electrode cap) and demonstrates substantial equivalence. It does not refer to a "test set" of data in the context of an algorithm's performance evaluation. The "study" here is a comparison of the new device's specifications and intended use against those of 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. There is no "ground truth" establishment in the context of an algorithmic test set for this device type and submission. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices based on their prior clearance or pre-amendment status.

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

   • Not applicable. No test set or adjudication process as described for an algorithm is mentioned or required for this type of device submission.

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

   • Not applicable. This is not an AI device, and no MRMC study is mentioned.

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

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

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

   • Not applicable in the AI sense. For this 510(k), the "ground truth" for the new device's safety and effectiveness is its direct comparison to legally marketed predicate devices whose safety and effectiveness are already established. The justification relies on the similarity of design, materials, and intended use to these pre-existing devices.

8. The sample size for the training set:

   • Not applicable. There is no "training set" for this physical device.

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

   • Not applicable. There is no "training set" or corresponding ground truth establishment for this physical device.

Summary for the Electrode Array Cap:

The Electrode Array Cap achieved FDA clearance (K071446) based on demonstrating substantial equivalence to two predicate devices:

• Electro-Cap (510(k) K780045)
• Quik-Cap (510(k) K000865)

The "study" presented in this 510(k) summary is a detailed comparison of the new device's intended use and technological characteristics with those of the predicate devices. The core argument for acceptance is that the Electrode Array Cap shares the same intended use (rapid placement of EEG electrodes in routine clinical settings) and similar technological features (elastic cap, sintered Ag/AgCl electrodes, shielded wires, compatibility with EEG amplifiers), while also conforming to relevant industry standards (AAMI EC53-1995, IEC 60601-1 subclause 56.3 (c)). The specific design choices, such as internal lead wires and PVC electrode holders, are presented as consistent with or minor variations from the predicate devices, not raising new questions of safety or effectiveness.

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