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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

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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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Electrode/extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

Electrode/Extension Cables, Models ATAR™

The provided text is a 510(k) clearance letter from the FDA for Electrode/Extension Cables. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device's AI or algorithmic component.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. This document is a regulatory approval letter, not a study report.

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E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.

The provided text describes a 510(k) summary for E Surgical Coated Electrodes. It outlines the device's indications for use, predicate devices, and a summary of its technological characteristics. However, the document primarily focuses on regulatory approval and substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria in the way a clinical study or robust scientific experiment would.

Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not explicitly stated in the provided 510(k) summary. The summary highlights safety and performance data in a general sense, aligning with regulatory requirements rather than providing a detailed study protocol and results.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document lists "Safety and Performance Data" but these are presented as characteristics the device meets rather than clearly defined acceptance criteria with numerical performance targets and reported results against those targets.

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

• Sample size for test set: Not specified. The document does not describe a formal "test set" in the context of a clinical or comparative study. The listed performance data (e.g., coating bend test) likely refers to in-house testing, but the sample sizes for these tests are not provided.
• Data provenance: Not specified. Given the nature of a 510(k) summary focusing on substantial equivalence and general safety/performance, the data provenance for the internal tests is not detailed (e.g., country of origin, retrospective/prospective).

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

Not applicable. The document does not describe a test set requiring expert-established ground truth in a clinical or diagnostic context. The performance claims are based on engineering and material characteristic tests rather than diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. No clinical or diagnostic test set requiring 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 electrode, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is an electrosurgical electrode and does not involve algorithms or AI for standalone performance evaluation in that context.

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

Not applicable in the conventional sense of diagnostic performance. The "ground truth" for the reported performance criteria would be:

• ANSI/AAMI HF 18: Compliance with the standard.
• Coating integrity: Visual inspection against cracking.
• Cutting/coagulation initiation: Likely observed by engineers or trained personnel during testing.
• Easy to clean properties: Subjective assessment or a defined cleaning protocol with a pass/fail criterion.
• Biocompatibility: Documentation/certification of meeting ISO 10993.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, for the same reason as above.

In summary: The provided 510(k) document is a regulatory submission for substantial equivalence. It confirms the device meets general safety and performance requirements and is comparable to predicate devices but does not contain the detailed study protocols, sample sizes, expert involvement, or statistical analyses typically found in clinical studies or papers proving specific performance against quantitative acceptance criteria for diagnostic devices.

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The ECG electrode is intended to monitor patients. The electrode monitors and relates body functions through a monitoring device. The electrode senses functions in the body, gathers information, and relates that information to the device with which it is connected. The information gathered by the electrode can then be assessed by medical personnel in order to aid in determining the proper medical course of action.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an "Electrode" device, identified by the trade name "FlectraMold". This document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results or acceptance criteria.

Therefore, the requested information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment is not available within this document.

This type of FDA letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. It does not typically include a detailed report of clinical or performance studies with specific acceptance criteria and their fulfillment.

To obtain the detailed information requested, one would need to refer to the original 510(k) submission (K050248) or the testing documentation submitted by Electramold.

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The device is intended to acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool. As with the predicate, the information transferred to EEG will be stored, interpreted and printed with commercially software programs available with Nihon Kohden marketed products.

The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional. The device will be available on all patient populations, including pediatrics.

The device is intended to record, measure and display the physiological data required for EEG and sleep studies (Polysmonography or PSG). These data, may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional on all patient populations.

The availability of new option, CO2 Sensor and accessory provides the physician the ease of connecting the CO2 adapter directly to the amplifier instead of separately connecting to a monitor. The product design and function is equivalent to the predicate in acquisition and data development. The same sensor design is utilized in both devices. The processing unit housed within the CO2 adapter, processes data, to continously monitor non-intubated patcint's CO2. The status of real time CO2 pressure, ETCO2, expiration, and the suction point, can be transferred by the elcctrode junction box to a Nihon Kohden's EEG monitor.

The provided text describes a 510(k) submission for an Electrode Junction Box (JE-921A Series) with an added CO2 input. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria.

Therefore, many of the requested elements for describing acceptance criteria and a study cannot be directly extracted from this document, as it is a regulatory submission for device clearance based on equivalence, not a performance study report.

However, I can provide information based on what is stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for a diagnostic claim) or numerically reported performance for such criteria. Instead, it states compliance with general and voluntary standards and successful completion of internal verification and validation testing.

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

The document does not describe a clinical test set or data provenance in the context of diagnostic performance or clinical accuracy. The testing mentioned refers to engineering and quality assurance tests.

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

Not applicable, as no clinical test set requiring expert ground truth establishment for a diagnostic claim is described.

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

Not applicable, as no clinical test set requiring 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 Electrode Junction Box and accessories, not an AI-powered diagnostic tool. There is no mention of AI or MRMC studies.

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

Not applicable, as this is hardware and does not involve a diagnostic algorithm.

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

For the internal testing described, the "ground truth" would be the engineering specifications and established standards (e.g., IEC standards, product specifications) against which the device's technical performance was measured. There is no mention of clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

Not applicable, as there is no mention of machine learning or deep learning models requiring a training set.

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

Not applicable, as there is no training set involved.

Summary of what the document does provide regarding "proof of meeting acceptance criteria":

The document primarily relies on:

• Compliance with established regulatory and voluntary standards: IEC 60601 series, 21 CFR Part 898.
• Internal verification and validation testing: This includes environmental, EMI/EMC, safety, and general performance testing, as well as software verification. The "acceptance criteria" for these tests were established based on "product specifications and applicable standards."
• Substantial Equivalence: The core argument for regulatory clearance is that the device is substantially equivalent to legally marketed predicate devices, implying similar safety and effectiveness parameters without requiring new extensive clinical performance studies. The CO2 module uses the "same sensor design" as a previously cleared module, and the overall design is "equivalent to the predicate in acquisition and data development."

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Technomed Europe diagnostic needle electrodes are intended to be inserted in the subdermal, muscle or nerve tissue to sense bio-electric, EMG or EEG, signals distally, and are intended to be proximal be connected to electromyography / electroencephalogram recording equipment.

The intended use of the Technomed devices are consistent with Code of Federal Regulations title 21, volume 8 part 882.1350.

Technomed Europe Needle electrode's and accessories consist of a variety of needle electrode's and accessories to be used for bioelectric sensing in the diagnostic field of EEG or EMG.

This document is a 510(k) premarket notification for Technomed Europe's EEG/EMG needle electrodes. It serves to establish substantial equivalence to previously marketed devices. The content provided does not describe a study involving acceptance criteria, device performance, AI, or ground truth establishment. Instead, it focuses on regulatory information required for FDA clearance.

Therefore, I cannot provide the requested information because the provided text does not contain details about: Acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, or how ground truth was established for training data.

The document explicitly states: "{1}------------------------------------------------ J) Intended use: Technomed Europe diagnostic needle needle electrode's are intended to be inserted in the subdermal, muscle or nerve tissue only to sense bio-electric, EMG or EEG, signals distally, and will proximal be connected to: Electromyography/electroencephalogram recording equipment K) Technological Characteristics: The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices." This sentence, in particular, indicates that the submission relies on the technological equivalence to predicate devices rather than new performance studies with specific acceptance criteria.

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The Cardima EP SELECT Switchbox is an accessory intended to provide selective connection of multi-electrode catheters for electrogram recording and pacing during diagnostic electrophysiology studies.

The Cardima EP SELECT Switchbox is a passive switching unit used in conventional electrophysiology (EP) diagnostic procedures. It is designed to provide a convenient means by which the user can record or pace from multiple unipolar or bipolar intracardiac electrodes. The device is designed to be placed on a horizontal surface or at the patient's side. It is designed to accept up to eight electrodes using standard pin connectors typically found in the EP lab. Switching between record or pace modes is accomplished by a simple switch for each electrode.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" in the context of clinical or performance data using a sample of devices. The safety and effectiveness study was based on conformance to an engineering standard. Therefore, traditional sample size and data provenance for a test set (e.g., country of origin, retrospective/prospective) are not applicable in the way they would be for a clinical study involving patient data. The study primarily involved testing the device itself against engineering specifications.

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

This information is not applicable. The ground truth was established by conformance to an industrial safety standard (IEC-60601-1), which involves engineering testing and evaluation, not expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable as the "test set" refers to the device being evaluated against an engineering standard, not a clinical dataset requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a passive switching unit, not an AI or diagnostic tool that would typically involve human readers interpreting cases.

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

No, a standalone (algorithm only) performance study was not conducted for an AI component. The device is a hardware component with a specific electrical function, not an algorithm. The study was focused on the device's electrical safety and functionality.

7. Type of Ground Truth Used:

The ground truth used was conformance to established engineering and safety standards, specifically International Electrotechnical Commission (IEC) electromechanical standard IEC-60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.

8. Sample Size for the Training Set:

This information is not applicable. The device is a hardware product, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This information is not applicable as there is no training set for a machine learning model. The safety and effectiveness were established through
"Declaration of Conformity" with a recognized consensus standard.

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