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

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

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

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

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

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

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

Not applicable. This device is a physical electrode, not an AI-assisted diagnostic tool.

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

Summary of what the document does convey:

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

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