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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.

Disposable Laryngeal Electrodes are non-invasive. The disposable device is constructed using a medical grade ink as electrode material suspended on a polyethylene substrate; a polyester connector with a separate available cable assembly or DIN 42802 connectors; The electrode is available in three sizes to suit different sexes and age groups. The 4/5mm electrode should be used with an 4 or 5mm endotracheal tube; the 6/7mm electrode should be used with a 6 or 7mm endotracheal tube; the 8/9mm electrode should be used with an 8 or 9mm endotracheal tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately. Using the laryngeal electrode lowers the risk of damage to the laryngeal or Xth cranial nerve (the Vagus nerve) during thyroidectomy or parathyroidectomy and, since it is noninvasive, it also lessens the risk of infection during the monitoring procedure.

The provided 510(k) summary for the Technomed Europe Laryngeal Electrode describes the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence, rather than providing acceptance criteria and a detailed study report. This submission does not contain a study that demonstrates device performance against specific acceptance criteria in the way typically found for AI/ML-enabled devices or performance studies with quantitative metrics.

Instead, the document focuses on establishing substantial equivalence based on design, materials, chemical composition, packaging, and other technological characteristics.

Here's an analysis of what information is present or absent based on your request:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) or clinical outcomes. The "acceptance" is implicitly defined by demonstrating equivalence to the predicate devices across various design and functional characteristics.
• Reported Device Performance: Not reported in quantitative terms. The document states that "Technomed Europe has been bench testing the Laryngeal Electrodes to confirm performance characteristics of this device" and that "The Technomed Europe Laryngeal electrodes are being bench tested in comparison to the predicated devices..." The characteristics to be tested include impedance and dimensions, among others. However, the results of these bench tests, or any performance metrics derived from them, are not provided in the summary. The "performance" is concluded to be "safe and effective" and "substantially equivalent" based on qualitative comparison.

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

• Not applicable. This submission does not describe a clinical performance study with a test set of patient data. The "testing" mentioned is bench testing of the electrode characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth establishment by experts is described as there is no human-interpreted test set data.

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

• Not applicable. No test set requiring expert adjudication is described.

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

• No. This device is a laryngeal electrode, not an AI/ML-enabled device. Therefore, no MRMC study or AI assistance is relevant here.

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

• No. This is a hardware device, not an algorithm.

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

• Not applicable. There is no ground truth data in the context of clinical performance described. The "ground truth" for the bench testing would be established by validated measurement standards and equipment against the defined physical and electrical properties of the electrodes.

8. The sample size for the training set

• Not applicable. This is a hardware device, not an AI/ML system requiring a training set.

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

• Not applicable. This is a hardware device, not an AI/ML system requiring a training set.

Summary of the Document's Approach:

The provided 510(k) summary is for a traditional medical device (laryngeal electrode), not an AI/ML-enabled diagnostic or therapeutic device. The "study" referenced is a bench testing comparison to predicate devices, focusing on demonstrating that the new device has "equivalent" design, materials, and functional characteristics to devices already on the market. The FDA's letter confirms substantial equivalence based on this comparison and the declared intended use.

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The Technomed Europe Kartush disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Kartush Disposable surgical stimulators are invasive devices used in the tissue dissection and monopolar stimulating. The instruments have different tip shapes for performing different dissection and stimulating procedures. The tip, tapered shaft, handle and connection pin are made of 1 pieces material. The instruments are designed for single-patient/multiple application use. The detachable lead wire has a safety DIN 42802 connector.

This document describes the premarket notification (510(k)) for Technomed Europe's Kartush Disposable Surgical Stimulators. It does not contain information about a study proving the device meets acceptance criteria in the way you've outlined for performance studies (e.g., diagnostic accuracy with medical imaging or other AI/software as a medical device).

Instead, this 510(k) submission establishes substantial equivalence to a predicate device (Medtronic Xomed Stimulus/Dissection Instruments, Ball-Tip Probes, K031003) for regulatory clearance. The "acceptance criteria" here are based on the comparison of characteristics between the proposed device and the predicate.

Here's an analysis based on the provided document:

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

For a 510(k) for substantial equivalence, the "acceptance criteria" are effectively that the proposed device demonstrates characteristics that are "same as" or "equivalent to" the predicate device, especially regarding safety and effectiveness.

• Dimensional measurements (current density)
• Impedance tests (through saline)
• Material comparison
• Dielectric strength test (shaft and handle insulation) |

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

• Test Set Sample Size: Not applicable in the context of a clinical study or a labeled "test set" for performance evaluation against a ground truth. The evaluation was based on a comparison of device specifications and the results of bench testing for the proposed devices against the characteristics of the predicate device.
• Data Provenance: The bench testing was conducted by Technomed Europe (manufacturer located in The Netherlands). The document does not specify if external labs were used or the specific origin of materials, but the testing was conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert consensus for ground truth on clinical data. The "ground truth" for this 510(k) is the established performance and safety profile of the predicate device, as already cleared by the FDA.

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

Not applicable. There was no clinical study involving human readers or cases requiring adjudication.

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

Not applicable. This device is a surgical instrument (nerve stimulator/locator), not an AI-powered diagnostic tool. Thus, an MRMC study is not relevant.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for this substantial equivalence submission is based on the previously FDA-cleared predicate device's design specifications, materials, and established indications for use and safety/effectiveness profile, as demonstrated through non-clinical (bench) testing. The non-clinical data (bench testing) performed on the proposed device aimed to confirm that its performance characteristics (e.g., current density, impedance, insulation integrity) were equivalent to those expected from the predicate.

8. The sample size for the training set

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

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

Not applicable. There is no "training set" for an AI/machine learning model. The basis of comparison is the predicate device's established regulatory clearance and characteristics.

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The Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.

Disposable Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. There are two types of electrodes, one with fixed lead wire and the other without lead wire, tab electrodes. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations. Tab electrode can be connected, using a lead wire with alligator clip, to the gel free contact strip at the electrode end.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria with numerical targets or performance metrics for the device. Instead, it focuses on the device's adherence to intended use and its substantial equivalence to predicate devices, supported by bench testing.

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

• Sample Size for Test Set: Not specified. The document only mentions "bench testing" was performed, but no details on the number of samples or specific test cases are provided.
• Data Provenance: The testing was conducted by Technomed Europe, which is based in The Netherlands. It is implied to be internal (bench) testing, not necessarily human subject data. The study is retrospective in the sense that it's a summary of testing already performed, rather than a prospective trial design.

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

• The document does not mention the use of experts to establish a ground truth for any test set. The evaluation focuses on the physical and functional characteristics of the electrodes through bench testing and comparison to predicate devices, not on diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication is mentioned or implied, as the study relies on bench testing and comparison to predicate devices for electrode performance, not subjective interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• No MRMC study was done. This device (Cutaneous Electrodes) is a hardware component used in medical procedures, not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, there's no mention of AI assistance or human reader improvement.

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

• Not applicable. This is a hardware device (electrodes), not an algorithm or software. Its performance is assessed through physical and functional bench testing, not as an "algorithm only" study.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily engineering and manufacturing specifications, along with performance characteristics defined by relevant standards and the performance of the predicate devices. For example, the adhesive qualities, conductivity, material safety, and signal acquisition capabilities would be objectively measured without requiring a clinical "ground truth" like pathology or expert consensus.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.

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

• Not applicable. As there is no training set for an algorithm, there's no ground truth established for one.

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The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP) and the electroencephalographic/evoked potentials reading is a completely non-invasive procedure that can be applied repeatedly to patients, normal adults, and children with virtually no risk or limitation. The electrodes are delivered non sterile and are available in reusable and disposable versions.

This document describes the acceptance criteria and study information for Technomed Europe's Cutaneous Electrodes (Cup Electrodes).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text describes a 510(k) submission for a cutaneous electrode (Cup Electrodes). In the context of a 510(k) submission for this type of device, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is primarily achieved through non-clinical bench testing to confirm performance characteristics. The document does not provide specific quantitative acceptance criteria or detailed device performance metrics in a structured table.

However, based on the information provided, the implicit acceptance criteria are:

• Substantial Equivalence: The design, materials, chemical composition, packaging, and other technological characteristics are equivalent to the predicate device (K061148: Rhythmlink Disc Electrodes).
• Performance Characteristics: The device confirms its performance characteristics through bench testing.
• Safety and Effectiveness: The device is deemed safe and effective for its intended use.

The reported device performance is that the "comparison to the predicate devices demonstrate that the cup electrodes are safe and effective and are substantially equivalent to the predicate devices."

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

The document states, "Technomed Europe has been bench testing the Cup Electrode to confirm performance characteristics of this device."

• Sample Size for the Test Set: Not specified. The document does not provide a number of units tested or a breakdown of the tests conducted.
• Data Provenance: The bench testing was conducted by Technomed Europe. This is a non-clinical, in-house study. The country of origin for the data is The Netherlands, where Technomed Europe is located. The study is prospective in nature, as it involves testing a newly developed device.

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

This information is not applicable. The device is a cutaneous electrode, and its performance evaluation for substantial equivalence primarily relies on non-clinical bench testing rather than the establishment of a "ground truth" by experts in the context of diagnostic interpretation. The evaluation focuses on physical and electrical properties, not interpretive results requiring expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where multiple readers or experts evaluate a case and their opinions need to be reconciled to establish a ground truth. Since this product involves bench testing and not clinical interpretation by experts, an adjudication method is not relevant.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Technomed Europe Cup Electrodes are physical medical devices (electrodes) used for signal acquisition, not diagnostic interpretation, and therefore, an MRMC study is not relevant to their evaluation. Furthermore, the device does not involve AI.

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

No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI system. It is a physical medical device. The "performance" assessment focuses on its physical and electrical characteristics through bench testing, not algorithmic performance.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically understood in diagnostic AI (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For this device, the "ground truth" or reference standards for performance are established through:

• Predicate Device Characteristics: The design, materials, and technological characteristics of the legally marketed predicate device (K061148: Rhythmlink Disc Electrodes) serve as a de facto reference for substantial equivalence.
• Bench Testing Standards: Industry standards and accepted methodologies for evaluating the physical and electrical performance of cutaneous electrodes would be the "ground truth" for the non-clinical tests performed.

8. The Sample Size for the Training Set:

This information is not applicable. A "training set" refers to data used to train machine learning models. This device is a physical electrode and does not involve any machine learning components, so there is no training set.

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

This information is not applicable, as there is no training set for this device.

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To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Disposable pedicle screw probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The disposable pedicle screw probes are supplied sterile and are for single use only. The disposable pedicle screw probes are connected to an electrical stimulator using a flexible lead wire and a "touch-proof" safety connector on the distal end. Disposable pedicle screw probes require a separate stimulator return electrode. Disposable pedicle screw probes are used by the surgeon to locate and identify spinal nerve roots and to assess nerve function. The disposable pedicle screw probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The disposable pedicle screw probes shaft may be bent to allow viewing access under a microscope.

Technomed Europe Disposable pedicle screw probes consist of an insulated probe shaft mounted to plastic handle. The probe shaft is electrically connected to a DIN 42802 "touch-proof" safety connector on the other end. The electrode is supplied in a sterile pouch.

The provided text is a 510(k) summary for the Technomed Europe Needle electrodes (Disposable pedicle screw probe). A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies.

Based on the provided document, the device is considered substantially equivalent to K062996. Therefore, the information requested, which pertains to detailed performance studies with acceptance criteria, expert ground truth, and training sets, is not present in this type of submission.

Here's an explanation based on the available information:

• Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or provide detailed performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device.
• Study That Proves the Device Meets Acceptance Criteria: The document mentions "Non-clinical data: Technomed Europe has been bench testing the Disposable pedicle screw probe for stimulating electrode to confirm performance characteristics of this device." However, it does not provide details of these bench tests, their methodology, sample sizes, or results against specific acceptance criteria.

Therefore, most of the specific questions cannot be answered from the provided text.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document only mentions "bench testing."
• Data Provenance: Not applicable, as no clinical study or specific test set with provenance is detailed.

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

• Not applicable, as no expert-derived ground truth for a test set is mentioned.

4. Adjudication method for the test set:

• Not applicable, as no test set with adjudication is mentioned.

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

• No. This is a medical device (electrode probe), not an AI diagnostic tool, so an MRMC study is not relevant here.

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

• No. This is a medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable, as no ground truth for performance evaluation is specified beyond the implicit demonstration of substantial equivalence to a predicate device based on its intended use and design characteristics.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

The drug used should be Botox Botilium Toxin type A.

Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.

The disposable hypodermic EMG needle electrode is designed for single use only. It consists of a stainless steel cannula electrically insulated with a PTFE coating, except for the lancet point and the inner surface of the tube. The coating is to ensure easy skin penetration and to ensure electrical insulation on the entire cannula, except for the point.
A husk fitting together with a wire with connection to an extension cable has been attached to the cannula. This cable will enable the electrical signal to be transferred to a stimulating or recording device.

The provided text describes a 510(k) premarket notification for a "Disposable hypodermic EMG needle electrode" (K062437) from Technomed Europe. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it outlines a regulatory submission for a medical device that has a long history of use and is compared to existing, legally marketed predicate devices.

Here's an attempt to answer the questions based on the available information, noting where data is absent:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study for a novel diagnostic algorithm would. The basis of this 510(k) submission is "substantial equivalence" to predicate devices, meaning the device performs similarly without raising new questions of safety or effectiveness.

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

• Sample Size: Not applicable. This submission relies on bench testing and comparison to predicate devices, not human or patient data in a "test set" as would be used for an AI or diagnostic algorithm.
• Data Provenance: Not applicable. The "non-clinical data" refers to "bench testing" performed by Technomed Europe (Netherlands).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of expert consensus or pathology is not relevant for this device's type of regulatory submission (a physical medical device establishing substantial equivalence). The determination of equivalence is made by the FDA based on the submitted information.

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

Not applicable. There is no human-involved "test set" and thus no adjudication method described.

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

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted or is relevant to this submission.

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

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

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

The "ground truth" for this type of submission is essentially regulatory compliance and demonstrating that the device is as safe and effective as existing, legally marketed predicate devices. It relies on:

• Bench testing results to confirm performance characteristics.
• Comparison of design, materials, and technological characteristics to established predicate devices (K973444: Teca Myoject disposable needle electrode; K002992: Medtronic Disposable Hypodermic Needle Electrode).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an algorithm being developed or tested.

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

Not applicable. There is no "training set."

Summary of what can be extracted from the document:

The document describes a 510(k) submission for a manual disposable hypodermic EMG needle electrode. The manufacturer, Technomed Europe, sought to demonstrate that their device is "substantially equivalent" to two existing predicate devices (Teca Myoject and Medtronic Disposable Hypodermic Needle Electrode).

The "study" in this context consisted of:

• Non-clinical bench testing to confirm performance characteristics. The specific tests and results are not detailed in this summary.
• Detailed comparison of the device's design, materials, chemical composition, packaging, and other technological characteristics to the predicate devices, concluding that they are equivalent.

The FDA's review of this information led to a determination of substantial equivalence, allowing the device to be marketed. The document does not describe a clinical trial, an AI algorithm, or patient data-driven performance metrics, which are often the focus of the requested information.

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The disposable probe is used:

• to locate and identify cranial motor nerves during ENT and intra-cranial procedures
• to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots
• to locate, identify and monitor cranial motor nerves during surgery
  The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

There are three types of disposable probes: Concentric, Bipolar and Monopolar
Disposable Concentric probe The Concentric probe is very precise and has a diameter of only 1 mm. They are especially useful when working with the microscope, and allow the surgeon to differentiate between cranial nerves, to stimulate within the Internal Auditory Canal, or to stimulate fine fibers of the extra-cranial nerve without stimulating surrounding tissue.
Disposable Bipolar probe The Bipolar probe has both the active and return electrode builds in to the probe. Both tips of the Bipolar probe must come into contact with tissue in order for the stimulation current to flow. The Bipolar probe will stimulate through a small amount of tissue. The Bipolar probe may be used in skull-base surgery and those involving peripheral motor nerves.
Disposable Monopolar probe The Monopolar probe has a single active electrode, but must have a remote return electrode connected to the patient. The Monopolar probe is insulated to a tip free coating length of 2 mm, so it is capable of very precise stimulation. The probe should be touched onto the tissue until the nerve is located. The Monopolar probe is designed to be used to stimulate the tumor mass or when a large spread is required.

The provided document describes a 510(k) premarket notification for "Needle electrodes" (Proprietary Name) or "Disposable probe" (Common/usual Name) by Technomed Europe. This document focuses on establishing substantial equivalence to previously marketed devices and does not contain information about studies proving the device meets acceptance criteria. The information provided is primarily for regulatory clearance and outlines the device's description, intended use, and technological characteristics.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or details about test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Details of standalone algorithm performance studies.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document's structure is typical for a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the medical device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It generally does not include detailed clinical study results or performance metrics in the way that would typically be found in a clinical trial report or a performance validation study.

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A RF Injection Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radio frequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radio frequency lesion may be made.

There are four types of needles: SMK, CXE, CX and RCN

SMK is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows an injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then place into the cannulae to create the lesion. The length of the cannula is insulated except for a section of the tip. The RF energy is then transferred from the electrode through this uninsulated portion which heats the surrounding tissue to create a lesion.

CXE is used for percutaneous facet denervations. The device consists of a shaft of hypodermic tubing, which is insulated except for 5mm at the tip. Plastic tubing and an electrical lead are unitized in a single flexible leader portion, which connects to the shaft. The lead is insulated and feed through the plastic tube. A Luer hub on the tubing allows injection of local anesthetic. The needle can be connected to a Radionics generator for stimulation and lesioning. The RF pole does not allow for temperature monitoring.

CX is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.

RCN is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hvoodermic tubing attached PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needle field.

The provided 510(k) summary for the "RF Injection Needles" does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity, or specific functional benchmarks).

This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on:

1. Intended Use: The device shares the same intended use as predicate devices: percutaneous nerve blocks with local anesthetic solution or radiofrequency lesioning, with nerve localization via electrical stimulation or contrast medium injection and radiography.
2. Technological Characteristics: The manufacturer states that "The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices."

Therefore, the requested information elements related to performance criteria, study design, expert involvement, and ground truth are not applicable to this specific 510(k) submission as no performance study was conducted or reported.

Here's a breakdown of why each point is not addressed by the provided text:

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

• Not Applicable: The document does not define specific performance acceptance criteria for the RF Injection Needles nor does it report any associated performance metrics like accuracy, sensitivity, or specificity. The submission aims to show substantial equivalence through intended use and technological characteristics rather than quantitative performance.

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

• Not Applicable: No test set or performance evaluation study is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: No ground truth establishment is mentioned as there was no performance study.

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

• Not Applicable: No test set adjudication is mentioned.

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

• Not Applicable: This is not an AI-enabled device; no MRMC study was conducted.

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

• Not Applicable: This is a physical medical device (needles), not an algorithm or software. Standalone performance is not relevant in this context.

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

• Not Applicable: No ground truth was established for performance evaluation within this 510(k) submission.

8. The sample size for the training set

• Not Applicable: This device is not an algorithm, so there is no training set in the context of machine learning.

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

• Not Applicable: As above, this is not an algorithm, so no training set or ground truth for it.

In summary: The provided 510(k) is a submission for a physical medical device demonstrating substantial equivalence to previously cleared predicate devices based on shared intended use and technological characteristics. It does not contain a performance study with acceptance criteria, test sets, or ground truth as these are typically required for novel performance claims or AI/software devices.

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