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Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Spes Medica Subdermal Needle Electrodes are monopolar needles intented to use for Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals in example and they are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. The Subdermal Needle Electrodes are used for recording and stimulation (micro stimulation), this stimulation has no therapeutic purpose but has the purpose of activating an electrical response.

The provided text describes the acceptance criteria and performance testing of the Spes Medica Subdermal Needle Electrodes, but it largely focuses on biocompatibility, sterilization/packaging, and electrical safety standards rather than a comparative effectiveness study involving human readers or AI.

Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale clinical data will not be present in this document.

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

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

2. Sample size 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 general "test sets" or data provenance in the way one would for an AI or clinical study. The performance tests are laboratory-based and conducted on the device components or prototypes. The sample sizes for each specific test (e.g., number of units tested for tensile strength, number of samples for biocompatibility) are not explicitly stated, nor is the country of origin or whether they were retrospective/prospective.

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

Not applicable. This document describes performance testing for a medical device to establish its safety and effectiveness based on international standards, not the establishment of ground truth by clinical experts for diagnostic accuracy.

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

Not applicable. This is not a diagnostic study requiring expert 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 document does not describe an AI device or an MRMC study.

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

Not applicable. This is not an AI device.

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

For the various performance tests, the "ground truth" is defined by the requirements of the international standards (e.g., ISO, ASTM, IEC) that the device must meet. For biocompatibility tests, it's the biological response against established thresholds; for electrical safety, it's adherence to voltage and isolation limits; for mechanical tests, it's resistance to forces.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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The DMS Disposable Subdermal Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

The DMS Disposable Subdermal Needle Electrodes are supplied sterile and intended for single use. This subdermal needle electrodes can be used to record the neurological and neurophysiological evoked potentials. The connector is provided with touch-proof and cannot be connected to an AC outlet. This connector is designed for connecting the recording or monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals. The DMS Disposable Subdermal Needle Electrodes are supplied sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DMS Disposable Subdermal Needle Electrodes, formatted to answer your questions:

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

The document does not explicitly state acceptance criteria in terms of specific performance thresholds for each test (e.g., "stiffness must be X Newton-meters"). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion is that the device passes or meets the requirements of these standards and tests, demonstrating performance comparable to the predicate.

Note: The document states that the proposed device was "found to be similar to predicate device with regard to design, function, and technical characteristics" and "presented the substantial equivalence," implying all tests were successfully passed and demonstrated equivalency.

2. Sample size 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 the sample sizes used for any of the non-clinical tests (biocompatibility, performance, shelf-life). These are typically laboratory tests performed on a limited number of device samples. The data provenance (country of origin, retrospective/prospective) is not mentioned, but given it's a 510(k) submission from "Daehan Medical Systems Co., Ltd." in "Republic of Korea," it's highly probable the testing was conducted in South Korea or by certified labs on behalf of the company. These are non-clinical, controlled laboratory studies, not human clinical trials, so the terms "retrospective" or "prospective" are not generally applicable in the same way they would be for patient 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)

This information is not applicable to the type of studies described. The "ground truth" here is based on standardized test methods and measurement results rather than expert interpretation of medical images or patient outcomes. The studies are non-clinical (biocompatibility, mechanical performance, electrical properties, shelf-life).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly when interpreting ambiguous medical data. The tests performed here are objective laboratory measurements against established 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

Not applicable. MRMC studies are clinical studies involving human readers (e.g., radiologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. This submission is for a medical device (subdermal needle electrodes) and focuses on non-clinical testing to demonstrate substantial equivalence, not AI algorithm performance.

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

Not applicable, as this device does not involve an AI algorithm.

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

The ground truth for the non-clinical tests is based on established industry standards and test methods. For example:

• Biocompatibility: Ground truth is defined by the criteria within ISO 10993-5 (absence of cytotoxicity) and ISO 10993-10 (absence of irritation/sensitization).
• Performance (Stiffness, Breakage, Bond, Electrical Properties): Ground truth is defined by the expected physical and electrical characteristics as determined by engineering specifications and comparative data to the predicate device.
• Shelf-life: Ground truth is defined by the ability of the device and its packaging to maintain sterility and functional integrity after accelerated aging, conforming to ASTM F1980-07:2011.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

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

Not applicable.

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E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue.

The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM).

The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. There are three specifications for E-Shield Multi-paired Subdermal Needle Electrodes, 7mm, 13mm and 19mm. The sterilized PET box contains 2 sets of 5-paired, 2 sets of 4-paired or 1 set of single subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into multi-paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.

The provided text describes the regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes (K142470) and its substantial equivalence to a predicate device (K140200). It focuses heavily on non-clinical testing for safety and effectiveness rather than a clinical study evaluating diagnostic or prognostic performance.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, especially in the context of efficacy for a diagnostic or prognostic medical AI device, is largely not applicable to this submission as it pertains to a needle electrode, not an AI device.

Let's break down what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing categories and the standards applied. The "performance" here refers to meeting these safety and manufacturing standards, not analytical or clinical performance in the sense of accuracy, sensitivity, or specificity commonly associated with AI/diagnostic devices.

The overall reported performance is: "All the test results demonstrate E-Shield Multi-paired Subdermal Needle Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses."

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

This section is Not Applicable in the context of an "AI device" test set. The testing performed was non-clinical for safety, sterility, biocompatibility, and material properties. Sample sizes for these types of engineering and materials tests are typically determined by relevant ISO/ASTM standards and Good Manufacturing Practices (GMP) for device validation, not by patient data samples. The data provenance is from laboratory and manufacturing validation processes, not country of origin of patient data or retrospective/prospective studies.

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

This is Not Applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic performance evaluation. The "ground truth" for this device's testing was established by adherence to the specified international and national standards by qualified testing facilities and personnel.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth for diagnostic tasks. This device underwent non-clinical testing against established 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

Not Applicable. This device is a needle electrode, a hardware medical device for signal acquisition, not an AI algorithm designed to assist human readers in interpreting medical data. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not Applicable. This is a physical medical device (needle electrode), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's regulatory clearance is compliance with the detailed standards and regulations listed for sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance (e.g., ISO, ASTM, USP, IEC standards).

8. The sample size for the training set

Not Applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. As above, this is a physical medical device, not an AI algorithm requiring a training set with established ground truth.

Summary for the provided document:

The regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes demonstrates its safety and effectiveness through non-clinical testing against a comprehensive set of national and international standards. These tests cover sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance. The device was found to meet all pre-defined acceptance criteria derived from these standards. No clinical trial data or AI/algorithm performance studies were conducted or required, as the device is a needle electrode and not a diagnostic or AI-driven system. The substantial equivalence argument relies on comparing the device's intended use, design, technological characteristics, and materials to a legally marketed predicate device, with the only difference being the addition of a new needle length specification and revised product categories, which did not raise new safety or effectiveness concerns after testing.

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E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM). The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. Each sterilized PET box contains 2 sets of 5-paired subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into 5 paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.

The manufacturer, NeuroInvent Inc., established acceptance criteria and conducted non-clinical testing to demonstrate that "E-Shield Multi-paired Subdermal Needle Electrodes" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many electrodes were tested for biocompatibility, sterility, etc.). It only lists the standards to which the tests were conducted.

The data provenance is from non-clinical testing performed by NeuroInvent Inc. There is no mention of patient data or specific geographic origin for the test materials beyond the product being manufactured by a company based in Mountain View, CA, with contact information in Taiwan.

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

This information is not applicable as the study involved non-clinical, bench testing rather than studies requiring expert interpretation of patient data to establish ground truth. The acceptance criteria were based on recognized international and national standards for medical devices.

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

This information is not applicable as the study involved non-clinical, bench testing. Adjudication methods are typically employed in clinical studies or studies involving human readers to resolve discrepancies in interpretations.

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 comparative effectiveness study was done. The document explicitly states: "No clinical test data was used to support the decision of safety and effectiveness." The device is a physical medical electrode, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical medical electrode, not a standalone algorithm. The non-clinical testing evaluated the physical and material properties of the electrodes.

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

The "ground truth" for the non-clinical testing was established by adherence to established international and national standards and regulations for medical devices (e.g., ISO, ASTM, USP, IEC, GB/T). The tests performed according to these standards (e.g., cytotoxicity tests, pyrogen tests, seal strength tests, electrical resistivity tests) provide the "ground truth" for the device's physical and material properties.

8. The sample size for the training set:

This information is not applicable. There was no training set, as the study involved non-clinical, bench testing of the physical device to meet predefined standards, not machine learning model training.

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

This information is not applicable as there was no training set.

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Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

Needle Electrodes are passive devices used for recording, monitoring and stimulation during EEG, EMG, nerve conducting studies and IONM. The Needle Electrodes have different tip shapes for performing different recording and stimulating procedures.

The Needle Electrodes are disposable and designed for single use and are labeled accordingly. The disposable Needle Electrodes are delivered sterile and can be used after opening of the sterile package.

The needles are comprised of a stainless steel or platinum alloy needle, electrically connected to a lead wire. or with a connector for connection to a separate lead wire. Monopolar needles are coated with a polytetrafluoroethylene coating. In case of a pre-connected lead wire the other end is a regular industry standard DIN 42802 safety connector.

The needles are invasive as they are used subcutaneously. Positioning and use is under supervision of a licensed physician.

Here's a breakdown of the acceptance criteria and study information for the Disposable Monopolar and Subdermal Needle Electrodes (K130136), based on the provided 510(k) summary:

This device is a Class II medical device (Needle Electrode, product codes GXZ and IKT) and its approval is based on establishing Substantial Equivalence (SE) to predicate devices, rather than a clinical effectiveness study with strict acceptance criteria often seen in AI/algorithm-driven devices. Therefore, the "acceptance criteria" here refer to meeting the characteristics and performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The electrodes are sterile and for single patient use only.

Xian Friendship Electronics Co., Ltd.s' Subdermal Needle Electrodes are disposable (for "Single Use Only"),sterile devices used to detect electrophysiological signals or provide electrical stimulation subcutaneously.

The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment.

The safety connector is an industry standard DIN 42802 protected, "touch proof connector and cannot be connected to an AC outlet.

Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.

Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.

The provided document is a 510(k) summary for the Xian Friendship Electronics Co., Ltd.'s Subdermal Needle Electrodes, seeking clearance from the FDA for substantial equivalence to predicate devices. It does not contain information about a study proving device performance against specific acceptance criteria in the context of AI/ML or comparative effectiveness. Instead, it relies on demonstrating similarity to already cleared predicate devices.

Therefore, many of the requested sections (e.g., specific acceptance criteria for performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) are not applicable or not provided in the document.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance Study for Xian Friendship Electronics Co., Ltd.'s Subdermal Needle Electrodes

This submission primarily focuses on demonstrating substantial equivalence to predicate devices through similarities in materials, design, and function, rather than presenting a de novo study with explicit performance acceptance criteria typical of novel or AI/ML-driven devices.

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, explicit performance acceptance criteria and reported numerical performance metrics are not provided as they would be for a direct performance study. The "acceptance criteria" here are implicitly meeting the safety and effectiveness standards demonstrated by the predicate devices. The device meets these by being "identical" or "similar" in key characteristics.

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

• Sample Size: Not applicable. There was no formal "test set" of patient data or images in the context of evaluating performance metrics.
• Data Provenance: Not applicable. The submission relies on design and material comparisons to predicate devices, not on data from specific patients or studies.
• Retrospective or Prospective: Not applicable.

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

• Number of Experts: Not applicable. No ground truth establishment by experts was detailed for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable as no such study was performed or described.

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

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical medical electrode, not a software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the traditional sense of AI/ML or diagnostic device evaluation. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, which this new device aims to match through identical or similar design, materials, and function.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This document does not describe the development or evaluation of an AI/ML model, so there is no "training set."

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

• Ground Truth Establishment: Not applicable. There was no training set for an AI/ML model.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (implicit) acceptance criteria for safety and effectiveness is primarily a non-clinical comparative analysis against legally marketed predicate devices (Axon Systems, Inc.'s Subdermal Needle Electrodes (K050194), Rhythmlink International Subdermal Needle Electrodes (K022914), and Medtronic Functional Diagnostics A/S Disposable Monopolar Needle Electrodes (K990375)).

The manufacturer states:

• "The materials of construction of the Subdermal Needle Electrodes are identical to those for the Axon Systems, Inc.'s Subdermal Needle Electrodes and Rhythmlink International Subdermal Needle Electrodes."
• "The safety feature and other functional and performance characteristics of the Subdermal Needle Electrodes are identical to those 'Predicate Devices'. Those features and characteristics were already verified and validated."
• "Clinical studies were not deemed necessary regarding the Subdermal Needle Electrodes due to their similarity in materials, design and function to those 'Predicate Devices'."
• "The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use." (No further details on this simulated use test were provided, such as sample size, methodology, or specific criteria).
• Biocompatibility relies on the known biocompatibility of the materials (medical grade 304/316 series Stainless Steel) and prior testing reported in the predicate device 510(k) submissions.

In essence, the "study" is a justification for substantial equivalence based on direct comparison of design specifications and materials to already cleared devices, coupled with a brief mention of a simulated use test.

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Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment. The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet. Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.

The provided text describes a 510(k) premarket notification for Axon Systems' Subdermal Needle Electrodes. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device.

Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training) are not applicable to this type of submission as the core of a 510(k) is about demonstrating similarity to existing, legally marketed devices.

However, I can provide information based on what is available in the document:

1. Table of Acceptance Criteria and the Reported Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate devices, or that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states: "Axon Systems' Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This is the core performance claim in the context of a 510(k). Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided as they are typically not required for this type of submission unless a significant new technological feature is being introduced that affects performance beyond that of the predicate.

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

• Not Applicable: This was a 510(k) submission focused on substantial equivalence to predicate devices. There is no mention of a "test set" in the context of a performance study with human subjects or a dataset. The evaluation likely involved technical comparisons and analysis of the device's design, materials, and intended use against the predicate devices.

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

• Not Applicable: See point 2.

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

• Not Applicable: See point 2.

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 Subdermal Needle Electrode, which is an invasive medical device for recording and stimulating biopotential signals. It is not an AI-powered diagnostic imaging device or software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not Applicable: This device is hardware and is used by a licensed physician or technologist. It does not operate as a standalone algorithm in the way AI software would.

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

• Not Applicable: The concept of "ground truth" as used in performance studies (e.g., for diagnostic accuracy) is not relevant here. The "truth" in a 510(k) is established by successfully demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it shares their fundamental safety and effectiveness profile.

8. The sample size for the training set:

• Not Applicable: See point 2. There is no mention of a "training set" as this is not an AI/machine learning device requiring such a component.

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

• Not Applicable: See point 8.

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Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Rhythmlink International Subdermal Needle Electrodes are single patient use, disposable, sterile devices. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue.

The electrodes consist of a stainless steel needle with a lead wire attached. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet.

The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.

This submission is for a Class II medical device, Subdermal Needle Electrodes, and as such, the provided text does not contain the level of detail regarding device performance studies, acceptance criteria, or ground truth establishment that would be present for a complex AI/ML-based diagnostic device. The documentation primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Therefore, many of the requested categories cannot be filled as they are not applicable to this type of device clearance given the provided information.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission for a Subdermal Needle Electrode. Regulatory clearance for this type of device relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance metrics from a clinical study with acceptance criteria as one would find for an AI/ML diagnostic or a novel therapeutic. The "performance" here relates to the device's technological characteristics being similar enough to the predicates that no new questions of safety or effectiveness are raised.

If we were to infer "acceptance criteria" for a physical device like this, it might involve:

• Material Compatibility: Biocompatibility of materials (stainless steel, lead wires).
• Sterility: Ability to maintain sterility.
• Electrical Conductivity/Impedance: Ability to reliably transmit biopotential signals.
• Mechanical Integrity: Strength of the needle and lead wire attachment.
• Safety Connector: Proper function of the safety connector to prevent connection to AC power.

However, the provided document does not include explicit test results or acceptance criteria for these aspects. The statement "The characteristics of Rhythmlink International Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised." is the overarching "performance" claim.

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

Not applicable. There is no "test set" in the context of a clinical performance study as described for AI devices. The submission relies on a comparison of the device's design and materials to predicate devices. There wouldn't be a "data provenance" as it's not a data-driven device; it's a physical medical instrument.

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

Not applicable. There is no test set or ground truth in the context of a clinical performance study using expert consensus. The "ground truth" for this type of device is established through engineering and materiological standards, and the safety track record of similar predicate devices.

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

Not applicable. No test set requiring adjudication of findings is mentioned.

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 physical electrode, not an AI-assisted diagnostic tool.

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

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

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

For this type of device, the "ground truth" is typically understood through:

• Engineering Standards: Electrical, mechanical, and material properties confirmed through bench testing (not detailed in this summary).
• Biocompatibility Standards: Ensuring the materials are safe for human contact.
• Predicate Device History: The long-standing safe and effective use of the identified predicate devices provides the basis for substantial equivalence.

The document does not detail specific "ground truth" establishment as would be done for diagnostic accuracy claims.

8. The sample size for the training set

Not applicable. This device is a physical electrode and does not involve AI/ML training.

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

Not applicable. This device is a physical electrode and does not involve AI/ML training or a training set.

Summary of what the document does convey:

• Device: Rhythmlink International Subdermal Needle Electrodes
• Intended Use: For use with recording, monitoring and stimulation equipment for the purpose of recording biopotential signals (e.g., EMG, EEG, Nerve potential signals). Sterile, single-patient use.
• Technological Characteristics: Stainless steel needle with a lead wire, terminating in a safety connector that prevents connection to AC power. Invasive (subcutaneous or in contact with nerve/muscle).
• Predicate Devices:
  • K990015 (Technomed Europe, Various Needle Electrode)
  • K010019 (Nicolet Biomedical, Sterile Subdermal Needle Electrodes)
• Basis for Clearance: Substantial equivalence to predicate devices, asserting that no new questions of safety or effectiveness are raised. This is the "study" and the "acceptance criteria" presented in the context of this 510(k).

Ask a specific question about this device

The Neuroline Subdermal Needle Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are sterile and for single patient use only.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Neuroline Subdermal Needle Electrode. This type of letter declares substantial equivalence to a predicate device and permits marketing. It is not a study report or a summary of acceptance criteria and performance data.

Therefore, the requested information (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, ground truth establishment, training set size) is not available within this document.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailing the technical specifications and clinical study results that would typically contain the information you've requested.

Ask a specific question about this device

Ask a specific question about this device