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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.

Disposable Subdermal Needle Electrodes, Corkscrew are single-patient use electrodes, delivered Ethylene Oxide (EtO) sterilized. They include a needle at one end which is connected to a lead wire with a 1.5 mm female safety DIN 42802 connector. The needle, which is fabricated using stainless steel, is formed into a corkscrew shape, with a regular bevel tip. The connecting lead wire, which may be supplied in different lengths and colors is terminated with a DIN 42802 connector to enable connection to recording or monitoring / stimulation equipment.

The document provided describes a 510(k) premarket notification for a medical device, specifically a "Disposable Subdermal Needle Electrode, Corkscrew." The purpose of this notification is to demonstrate substantial equivalence to an existing legally marketed predicate device. This type of submission relies on non-clinical testing to show that changes do not raise new questions of safety or effectiveness, rather than a clinical effectiveness study comparing the device to a gold standard.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of diagnostic accuracy, AI, and human reader performance, is not applicable to this submission. This document focuses on demonstrating that a modified version of an existing device is just as safe and effective as its predicate through various engineering and biocompatibility tests.

Here's a breakdown of why many of your questions cannot be answered from this document:

• Acceptance Criteria & Device Performance (Table): While the document lists "tensile strength" and "impedance" as performance metrics with target values (which can be considered acceptance criteria in an engineering sense), these are not diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that would be relevant to an AI/diagnostic device study. The reported performance is that the device "passed the tests and meets the set requirements."

  Acceptance Criteria and Reported Device Performance

• Sample Size for Test Set & Data Provenance: Not applicable as this is not a diagnostic device study. The "test sets" here refer to batches of devices used for various engineering and biocompatibility tests.
• Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth in this context would be engineering specifications and validated test methods, not expert consensus on diagnostic interpretations.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device.
• Standalone Performance: Not applicable. This is not an AI algorithm. Its "performance" relates to its physical and electrical properties, not diagnostic accuracy.
• Type of Ground Truth Used: The ground truth for the non-clinical tests is established by recognized international standards (e.g., ISO, ASTM, IEC) and internal test methods with defined specifications. For sterility, it's a Sterility Assurance Level of 10^-6. For biocompatibility, it's compliance with the ISO 10993 series.
• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning sense.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of Non-Applicable Information and Reasons:

The studies performed were non-clinical tests to ensure the device's physical, electrical, and biological safety and performance:

• Performance Testing: Visual, dimensional, electrical (impedance), and mechanical (torsion, pull force) aspects were tested using internal methods.
• Shelf Life (Accelerated Aging): Tested according to ASTM F1980-21, including mechanical, dimensional, electrical, visual, label assessment, and pouch integrity.
• Transit Testing: Electrical and mechanical assessment, label assessment, and pouch integrity after transit simulation (ISTA 3A).
• Electrical, Mechanical and Thermal Safety: Compliance with IEC 60601-1 (Ed. 3.2), specifically section 8.5.2.3.
• Biocompatibility: Extensive testing (Chemical characterization, cytotoxicity, intracutaneous reactivity, acute systemic toxicity, sensitization, pyrogenicity) performed by an external laboratory in accordance with the ISO 10993 series and related standards.
• Sterilization: Validation leveraged from the predicate device (ISO 11135:2014) as the changes did not affect sterilization.
• Pyrogenicity: LAL test performed after sterilization.
• Usability: Applied the "User Interface of Unknown Provenance" (UOUP) principle according to IEC 62366-1, considering the user interface remained unchanged from the predicate.

In conclusion, the document successfully argues for substantial equivalence based on rigorous engineering, material, and safety testing, but it does not contain the type of diagnostic performance data or AI study details you requested.

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This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.

Medical disposable sterile needle electrodes are sterile, single use products that penetrate the skin and directly contact the extracellular fluid during use, forming a good electrolyte interface. The pointed part of the needle electrode makes contact with the nerves, muscles, or other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires.

This appears to be an FDA 510(k) clearance letter for a Medical Disposable Sterile Needle Electrode. The document describes the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.

Crucially, this document is for a medical device (a physical needle electrode), not a software/AI-driven device that would involve a test set, ground truth experts, MRMC studies, or training sets in the way your request describes. Therefore, many of the requested criteria are not applicable.

However, I can extract the information that is present and explain why other sections are not relevant.

Here's an analysis based on the provided document:

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

The acceptance criteria for this type of device are primarily based on non-clinical performance (physical and biological safety) and demonstrating substantial equivalence to a predicate device. There isn't a "performance" metric in the sense of accuracy, sensitivity, or specificity as one would find for an AI algorithm.

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

This information is not applicable to this type of device. The "tests" mentioned are physical and chemical laboratory tests on manufactured samples of the device, not clinical data sets of patients. There is no concept of "data provenance" in the context of clinical images or 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 is not applicable. There is no "ground truth" established by experts in the context of an electromyography needle electrode. The performance is assessed through standardized laboratory tests.

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

This is not applicable. There is no "test set" requiring adjudication in the context of an electromyography needle electrode.

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. This is a physical medical device, not an AI software. MRMC studies are used for evaluating diagnostic imaging AI.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

As mentioned, "ground truth" in the AI/software sense is not applicable. For this device, the "truth" is established by adherence to recognized international standards for biocompatibility (ISO 10993 series), sterilization (ISO 11135), and general physical performance testing (e.g., surface quality, sharpness, electrical conductivity).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device.

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

This is not applicable. There is no "training set" or associated "ground truth" for a physical medical device. The "truth" is established through engineering design, material science, and adherence to established manufacturing and testing standards.

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Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.

TSI's Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes. They are supplied sterile, are non-pyrogenic, and are intended for single use only.

This document is a 510(k) premarket notification for a medical device called "Phantom XL Insulated Dilators". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific performance metrics like sensitivity, specificity, or AUC.

Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device performance studies (which would involve metrics like sensitivity, specificity, human reader performance, etc.) is not applicable to this submission.

This submission focuses on engineering-level performance testing to demonstrate that changes made to the existing predicate device (Phantom XL Insulated Dilators, K140088) do not raise new questions of safety or effectiveness. The changes are minor:

• Change in packaging: from backer card/Tyvek pouch/Shelf Box to preformed tray sealed in Tyvek Lid placed in Shelf Box.
• Extended shelf life: from 2 years to 5 years.

The acceptance criteria and studies described relate to these specific physical changes and their impact on the device's ability to maintain sterility, packaging integrity, and functionality over its extended shelf life.

Here's a breakdown of the information provided, reframed to fit the context of this 510(k) submission:

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

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one might expect for a diagnostic or AI device (e.g., sensitivity > X%, specificity > Y%). Instead, it lists the types of changes made to the device and the standards/tests performed to ensure these changes do not negatively impact safety and effectiveness. The "acceptance criteria" are implied by compliance with the referenced ASTM, ISO, and AAMI standards. The "reported device performance" is that the device "demonstrates that the TSI Phantom XL Dilators are safe for use perform comparably to the predicate device that is currently marketed for the same intended use" after these tests.

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

The document does not specify exact sample sizes for each test listed (e.g., how many packages were tested for seal strength). The studies mentioned are engineering/bench tests on the device and its packaging components, not human subject studies. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not relevant here.

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

This is not applicable. The "ground truth" for this type of submission is defined by the technical specifications of the device and its packaging, and ensuring compliance with recognized industry standards (ASTM, ISO, AAMI). There is no "ground truth" to be established by medical experts (e.g., radiologists interpreting images) as this is not a diagnostic device with performance metrics relying on human interpretation. The testing is performed by engineers and technicians following standard protocols.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when there's ambiguity in establishing a ground truth (e.g., for disease diagnosis from images) or for resolving disagreements among multiple human readers. This submission describes physical and performance tests against standards, not diagnostic performance.

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. This device is a surgical instrument (an insulated dilator used for nerve stimulation/localization during spine surgery), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

This is not applicable. As stated above, this is a surgical instrument, not an algorithm or AI device.

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

The "ground truth" in this context is the compliance with established engineering and medical device standards (ASTM, ISO, AAMI). For example, for packaging, the "ground truth" is that the seal strength meets the requirements specified by ASTM F88, or that the sterility assurance level (SAL) meets the requirements of ANSI/AAMI ST67 after ethylene oxide sterilization. It's about meeting predefined technical specifications and standards, not a medical condition.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI or machine learning model. There is no "training set."

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

This is not applicable. As there is no training set for an AI or ML model, this question does not apply.

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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), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use.

Guardian Needle™ Electrodes are a sterile, single-use device. The electrodes are applied during the study of biopotentials such as electromyography (EMG), electroencephalography (EEG), nerve conduction and stimulation/response. The electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The needle is housed inside a sheath until application and secured to the patient during use with adhesive tape.

The Rhythmlink International Guardian Needle™ Electrode (subject device) is compared to the predicate device, Subdermal Needle Electrodes (K022914), to demonstrate substantial equivalence. The document primarily focuses on non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences: The subject device includes a needle sheath (thermoplastic polyester elastomer sheath) and adhesive tape, which differ from the predicate device (PVC tube for sheath, no adhesive tape). These differences were assessed through testing and determined not to adversely impact safety or effectiveness.

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

The document does not specify exact sample sizes for the functional performance benchtop tests (Electrical Continuity and Adhesion Testing). However, it states that "The test methods were identical to those used to assess the predicate device."

For sterilization, reevaluation of EtO residuals was performed, but the sample size is not explicitly stated.

The data provenance is from non-clinical benchtop testing conducted by Rhythmlink International, LLC. The document does not indicate any country of origin for the data that would suggest external sources. All testing appears to be retrospective relative to the submission date, as it's part of a 510(k) premarket notification.

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

This information is not provided in the document. The document describes non-clinical benchtop tests and compliance with recognized standards. There isn't an explicit "test set" in the context of expert review for establishing ground truth, as the criteria are based on engineering and biocompatibility standards.

4. Adjudication method for the test set

This information is not applicable as the document does not describe a test set requiring expert adjudication for ground truth (e.g., image interpretation). The evaluation relies on established engineering and biocompatibility testing methodologies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)" and "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3)."

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

This question is not applicable as the device is a physical invasive medical electrode, not a software algorithm or AI system.

7. The type of ground truth used

The "ground truth" for demonstrating the device meets acceptance criteria is primarily based on:

• Compliance with recognized industry standards: ANSI/AAMI/ISO 10993-7:2008/(R) 2012 for EtO residuals, ISO 10993 for biocompatibility, IEC 60601-1-1: 1988/a1: 1991/A2 :1995 § 56.3(c) per CFR 898.12, DIN 42802, ISO 14971, ISO 15223-1, and TIR 28:2009 Guidance for sterilization.
• Predicate device characteristics: Substantial equivalence is established by demonstrating the subject device has identical technological characteristics, intended use, and performance to a legally marketed predicate device, with differences (needle sheath, adhesive tape) assessed not to adversely impact safety or effectiveness.
• Benchtop test results: Electrical continuity and adhesion testing against predetermined acceptance criteria.

8. The sample size for the training set

This question is not applicable as the device is not an AI/ML product that undergoes training.

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

This question is not applicable as the device is not an AI/ML product that undergoes training.

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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 PressOn™ Electrode Headset is intended for use in the recording of electroencephalogram (EEG), evoked potential (EP), or as a ground and reference in an EEG or EP recording. The device is provided sterile for single patient use only.

The PressOn™ Electrode Headset is intended to be used in medical environments where quick EEG electrode application is required. The device provides a workflow solution where the availability of technologists or other specialty-trained EEG staff is limited for applying EEG electrodes.

The headset comprises between 2 to 48 PressOn™ Electrodes, each loaded into individual button applicators, which are positioned in predetermined locations and interconnected by elastic netting, altogether forming the headset. The predetermined electrode positions are arranged by generally referencing the 10-20 Positioning System, but with flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, and other separate devices. Like the predicate, the subject device is minimally invasive and does not directly contact neural tissues.

The PressOn™ Electrode Headset is placed on the patient's head and is oriented and secured using a nasion marker and chinstrap. The distal end of the device contains the array of PressOn™ electrodes in predetermined locations that are placed on the scalp by minimal insertion of the micro needles into the epidermis layer of the skin for use during monitoring procedures. The PressOn™ electrodes in the subject device are inserted in an identical fashion as the predicate device (K130220). Minor material and dimensional changes have been made to the original applicator to allow for multiple applicators to be connected to form the headset.

At the proximal end of the subject device is a multipin connector where the electrode leadwires terminate. The multipin connector interfaces with color-coded extension cables (identical to those used in another previously cleared Rhythmlink device, reference device K172503) that terminate into single pin connectors, which are then connected to monitoring equipment.

The leadwires are constructed of ribbon cable arrays with electrode attachment points at various distances based on the predetermined locations. These features are designed with the intent for quick application by non-neurological based medical personnel with signal quality equivalent to predicate device [K130220].

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format that directly maps to "AI performance metrics" commonly seen in such tables (e.g., sensitivity, specificity, AUC). Instead, it discusses functional performance equivalency to a predicate device based on benchtop tests.

However, we can infer the acceptance criteria and reported performance from the "Summary of Non-Clinical Tests" section:

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

The document explicitly states: "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)."

Therefore:

• Sample size for test set: Not applicable (no clinical test set).
• Data Provenance: Not applicable (benchtop testing on synthetic materials, not human data).

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

Not applicable, as no clinical tests were conducted and the "ground truth" was established based on engineering specifications and benchtop performance against predetermined criteria.

4. Adjudication Method for the Test Set

Not applicable, as no clinical tests were conducted involving expert adjudication.

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

No. The document explicitly states: "No Clinical Tests were conducted." Therefore, no MRMC study was performed, and no effect size for human readers with and without AI assistance is reported. This device is a hardware electrode headset, not an AI algorithm.

6. Standalone (Algorithm Only) Performance Study

No. The device is a physical electrode headset, not an AI algorithm. Therefore, a standalone algorithm-only performance study is not relevant and not reported.

7. Type of Ground Truth Used

The "ground truth" for evaluating the device's performance was established via:

• Engineering specifications and predetermined acceptance criteria for mechanical and electrical properties.
• Comparison to the predicate device (K130220) for functional equivalency, implying the predicate's established performance served as a baseline.
• Benchtop measurements and visual assessments on synthetic skin and head phantoms.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (electrode headset) and not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of 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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The MR Conditional PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is provided sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.

The design of the Rhythmlink Disposable MR Conditional PressOn electrode is identical to the existing PressOn electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures.

The device consists of a disk shaped electrode with three sets of flat tyne or micro needles made from Nitinol. The Electrode is permanently attached to a leadwire which is 10cm (100mm) in length. An accessory cable is supplied to attach to the 10cm electrode leadwire to create a 1.0, 1.5, 2.0 or 2.5 meter traditional lengths during the Monitoring procedure. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment at any time. A significantly shorter lead wire of 10cm is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length of the RF component. This condition reduces the probability of matching the RF wave length to the leadwire length and reduces the likely hood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures.

The provided text describes a 510(k) summary for a medical device, the "MR Conditional PressOn™ Electrode." This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and simulated testing related to MRI compatibility, rather than clinical efficacy studies. Therefore, many of the requested details regarding clinical study design, ground truth establishment, expert adjudication, and MRMC studies related to AI performance are not applicable to the information provided.

Based on the information given, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The primary acceptance criterion for this device, as stated, is related to temperature rise during MRI exposure, with the performance being compared against the IEC 60601-1-1 §11.1.2 standard.

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

The "test set" in this context primarily refers to the conditions simulated and tested for MRI compatibility, not a clinical patient dataset for evaluating diagnostic accuracy.

• Sample Size:
  • Simulation (SIMCAD X with FDTD modeling): Three different electrode types were simulated: Cup Electrodes, WEBB Electrodes, and PressOn™ Electrode. The PressOn™ electrode was determined to be the "worst-case configuration." The simulation data was then compared to actual MRI testing, using field strengths of 1.5T and 3.0T, and 68 MHZ and 128 MHZ respectively.
  • Real-time MRI Physical Testing: This testing was conducted using the "known worst-case configuration" (the PressOn electrode). The exact number of physical tests or specimens is not specified beyond this.
• Data Provenance: Not specified regarding country of origin. The studies were non-clinical (bench and simulation testing) and prospective in the sense that they were specifically conducted for this submission to evaluate the redesigned device's MRI compatibility.

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

Not applicable. This device submission focuses on the physical properties and safety during MRI exposure, not on diagnostic accuracy requiring expert interpretation or ground truth derived from clinical experts for image analysis. The "ground truth" here is the physical measurement of temperature and torque under defined MRI conditions.

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

Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation (e.g., radiologist reads) to establish consensus on challenging cases. For physical testing (temperature, torque), the results are objective measurements.

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 submission is for a neurological electrode, not an AI-powered diagnostic device. No human reader studies (MRMC) were conducted as part of this submission. The device's function is to record EEG/EP signals and remain safe in an MRI environment, not to assist human interpretation of medical images or data.

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

Not applicable. This is not an algorithmic device. Performance was evaluated for the physical device itself (its interaction with the MRI environment).

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

The ground truth used was objective physical measurements and simulations based on established engineering principles and standards (e.g., temperature measurements, torque measurements, and FDTD modeling). The performance was compared against a defined safety standard (IEC 60601-1-1 §11.1.2 for temperature).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As noted above, this is not an AI/ML device requiring a training set with established ground truth in the context of expert labels or outcomes.

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