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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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The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

• Somatosensory evoked potentials (SSEP)
• Motor evoked potentials (MEP),
• . Train-of-four neuromuscular junction (TO4),
• Triggered electromyography (tEMG) and ●
• . Free run electromyography (sEMG)

The provided text does not contain detailed information about specific acceptance criteria for the device's performance, nor does it describe a study that rigorously proves the device meets such criteria through a clinical validation or similar performance evaluation.

The document is a 510(k) premarket notification summary for the "SafeOp 3: Neural Informatix System." Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (SafeOp2: Neural Informatix System, K213849, and reference device Cascade IOMAX Intraoperative Monitor, K162199), rather than to present a full clinical performance study with defined acceptance criteria and detailed results.

Here's a breakdown of what the document does say, and what it lacks in relation to your request:

What the document provides:

• Device Name: SafeOp 3: Neural Informatix System
• Intended Use/Indications for Use: Monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ) during various surgical procedures.
• Technological Comparison: A table comparing the SafeOp 3 System to predicate and reference devices, focusing on technical specifications like monitoring modalities, amplifier channels, stimulation parameters (voltage, current, pulse duration, repetition rate), and filter ranges. This comparison primarily aims to establish that the differences in technology do not raise new questions of safety or effectiveness.
• Performance Data (Non-clinical): Mentions that "Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements." It also states "EMC and Electrical Safety Testing... was performed to ensure all functions... are electrically safe, and comply with recognized electrical safety standards." Usability testing was also performed.
• Clinical Information Disclaimer: Explicitly states, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

What the document lacks significantly for your request:

• A table of acceptance criteria and reported device performance: This is the most significant omission for your request. The document details technical specifications and comparisons but does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) against pre-defined acceptance thresholds for any of its functionalities (MEP, SSEP, EMG, NMJ). The performance data mentioned are non-clinical (functional, system, software, EMC, electrical safety, usability), not clinical performance metrics.
• Sample size used for the test set and data provenance: Since specific clinical performance studies are not detailed, this information is not provided.
• Number of experts used to establish ground truth and qualifications: Not applicable as a clinical ground truth establishment process for performance evaluation is not described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned or detailed.
• Standalone (algorithm only) performance: While the device is an "algorithm only" in a sense (it processes physiological signals), its performance isn't quantified in a standalone clinical evaluation or comparative study.
• Type of ground truth used: No clinical ground truth is described for performance evaluation.
• Sample size for the training set: Not applicable, as this is related to AI/ML development and training, which is not described. The device is a neuromonitoring system, not explicitly stated to be an AI/ML device in the context of this submission.
• How the ground truth for the training set was established: Not applicable.

Why this information is missing:

The FDA 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate, without necessarily requiring new clinical trials or detailed performance studies if the technological differences are minor and well-understood. The focus is on showing that any differences do not introduce new safety or effectiveness concerns.

In summary, based solely on the provided text, I cannot complete the table of acceptance criteria or describe a study that proves the device meets these criteria in a clinical performance context. The document focuses on demonstrating substantial equivalence through technical comparison and non-clinical testing, rather than presenting clinical performance metrics.

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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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The SafeOp 2: Neural Informatix System is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

The SafeOp™ 2: Neural Informatix System (SafeOp 2 System), formerly known as EPAD 2 (K182542), consists of the SafeOp head unit with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, and stimulating probe or clip contained in various kits. The SafeOp 2 System head unit contains a complete data acquisition system that has builtin stimulators, amplifiers, relays, A/D Converters, Digital Signal Processors, CPUs, and storage devices. The head unit interfaces with other equipment through communication ports and serves as the patient-contacting portion of the system where it is close to the surgical field. The head unit hardware contains an eight acquisition (input) channel and six-output channel Evoked Potential Stimulator that is used in the operating room to display nerve and muscle responses. The user can use these responses to diagnose insults to the peripheral or central nerves and to determine relative nerve location, proximity, and integrity data. The SafeOp 2 System application provides the primary graphical user interface and controls for the SafeOp 2 System. The application runs on a touchscreen tablet mobile device which connects to the head unit either via wired USB cable or wireless via Wi-Fi, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).

The provided text is a 510(k) summary for the SafeOp 2: Neural Informatix System. It primarily focuses on demonstrating substantial equivalence to a predicate device (EPAD™ 2 System, K182542) rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical performance.

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

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the typical sense of a clinical study measuring diagnostic accuracy or treatment efficacy. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various specifications. The "acceptance criteria" for this submission would broadly be that the device's specifications and performance are comparable to the predicate, with any differences not introducing new safety or effectiveness concerns.

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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 ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws).

The document provided is a 510(k) premarket notification for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, functionality, and performance testing. However, it explicitly states:

"Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This means the submission does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human-in-the-loop studies involving AI. The acceptance criteria and performance data provided are related to functional, electrical safety, biocompatibility, and reprocessing aspects of the surgical instruments themselves, not their performance in a clinical diagnostic or prognostic context with AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/clinical performance study.

The document covers the following types of acceptance criteria and proven performance for the ATEC IOM Accessory Instruments (which are surgical tools, not an AI diagnostic device):

1. Table of Acceptance Criteria and Reported Device Performance (Summary of Engineering/Safety Tests):

The document does NOT provide information for the following points, as they are not relevant to a device submission for surgical instruments focused on substantial equivalence based on material and functional safety rather than AI performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Ives MR Conditional Cup Electrodes are intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.

The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning.

The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging.

The cutaneous surface electrode (CPE) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, conductive plastic and Ag-Ag/Cl, materials that have long been used for this intended purpose throughout the industry and compatible to the MR environment. The conductive cup electrode is permanently connected to a PVC insulated copper lead wire varying in length from 6" to 9". This joint is then covered in a heatshrink tube to provide a strain relief. The lead wires are staggered in length (6" to 9") and terminate in a small mass connector that conforms to DIN 42-802 for electrical safety. A blue sponge is provided to locate the lead wire termination off of the scalp and at the top of the patient's head. To permit EEG monitoring, this small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802. The Harness is disconnected for imaging. The electrode lead length is as short as possible to connect directly with the 10-20 EEG scalp site. This prevents coiling of the lead wires and as short as possible lead length to reduce or eliminate the RF heating antenna effect during MR scanning sequences. Electrode and lead materials are selected to avoid use of any magnetic ferrous metals.

The provided document describes the FDA 510(k) premarket notification for the Ives MR Conditional Cup Electrode, focusing on its substantial equivalence to predicate devices and its MR Conditional properties.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one might expect in a detailed study report. However, it implicitly defines acceptance criteria through its claims of MR Conditional compatibility and the supporting non-clinical testing.

Here's a reconstruction of the implicit acceptance criteria and the device's performance based on the non-clinical testing section:

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

• Sample Size for Test Set: The document mentions "clinical testing" for image artifact, but does not specify the sample size (e.g., number of electrodes, number of subjects/patients) used for this testing.
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA submission and the company name ("Ives EEG Solutions, Inc." and "Newburyport, Massachusetts"), it is highly probable the testing was conducted in the United States. The document is a regulatory submission, not a research paper, so detailed provenance is not typically included here unless specifically requested by the FDA for certain study types. The testing described is non-clinical (thermal, electromagnetic compatibility) and clinical (image artifact assessment), implicitly making it prospective for the purpose of this submission.

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

This information is not provided in the document. The testing described focuses on physical properties (heating, artifact) rather than diagnostic accuracy or interpretation requiring ground truth established by medical experts for a test set. The "clinical testing" mentioned for image artifact would typically be assessed by radiologists, but the number and qualifications are not stated.

4. Adjudication Method for the Test Set

This information is not provided in the document. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation of data, such as diagnostic accuracy studies, which is not the primary focus of the non-clinical and basic clinical compatibility testing described here.

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

No, an MRMC comparative effectiveness study was not done and is not applicable here. This document is about the MR compatibility and basic safety of an EEG electrode, not about the diagnostic effectiveness of an AI algorithm or human readers. The device itself is an electrode, not an AI diagnostic tool.

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

No, a standalone study of an algorithm performance was not done. The device is an electrode, not an algorithm.

7. Type of Ground Truth Used

For the non-clinical testing (thermal, magnetic compatibility), the "ground truth" is established by:

• Physical measurements and scientific principles: Temperature rise is directly measured. Magnetic field interactions are assessed based on material properties and measured forces/torques.
• Established MR safety standards: Testing methods and thresholds are derived from recognized industry standards and regulatory guidance for MR compatibility.

For the "clinical testing" of image artifact, the "ground truth" implicitly refers to the direct observation and measurement of the artifact on MR images by qualified personnel (likely radiologists or MR physicists), compared against a baseline expectation or standard for acceptable artifact. It's not ground truth in the sense of a disease diagnosis but rather a direct physical effect.

8. Sample Size for the Training Set

Not Applicable. This device is a physical medical instrument (an electrode), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The non-clinical and clinical testing performed relates to the physical safety and compatibility of the device.

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

Not Applicable. As there is no AI algorithm and no training set, there is no ground truth to be established for a training set.

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