SLE EMG ELECTRODES AND ACCESSORIES by SPECIALIZED LABORATORY EQUIPMENT, LTD.

This FDA 510(k) K981004 for "SLE EMG Electrodes and Accessories" indicates that the device was cleared based on substantial equivalence to predicate devices, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this document. The FDA's 510(k) clearance process for this type of device at the time focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new performance studies.

Here's a breakdown of why this information is missing based on the provided text:

No new clinical or performance study was conducted or reported. The document repeatedly emphasizes substantial equivalence to existing devices.
The "Technological Characteristics" section specifically states: "The design, materials, H. composition, packaging, and other chemical technological characteristics of the subject device are considered to be the same as the technological characteristics of the predicate devices." This means the manufacturer didn't claim novel technology requiring new performance metrics.
The FDA clearance letter confirms: "We have determined the device is substantially equivalent...".

However, if we were to hypothesize what would be required for such a device if a performance study were conducted, and how the information would be presented in a typical regulatory submission (though not present here), it might look like this (purely illustrative, based on common neurophysiology electrode testing):

(Hypothetical, as this information is NOT in the provided document)

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

Performance Metric	Acceptance Criteria	Reported Device Performance (Hypothetical)
Impedance	< 10 kOhm (recommended for good signal acquisition)	< 5 kOhm (Average)
Signal-to-Noise Ratio (SNR)	> 20 dB	> 25 dB
Baseline Drift	< 10 µV/min	< 5 µV/min
Artifact Rejection	Qualitative assessment: No significant mains hum or movement artifact	Minimal discernible artifact under standard operating conditions
Durability (e.g., sterilization cycles for re-usable)	Maintain performance after X cycles (e.g., 20 cycles)	Performance maintained after 25 cycles
Biocompatibility	ISO 10993 compliant (Cytotoxicity, Sensitization, Irritation)	Passed ISO 10993 for surface-contacting devices
Patient Comfort (Pain score)	< 3 on a 0-10 Visual Analog Scale (VAS) during insertion and use (compared to predicate)	Average VAS score of 2 (comparable to predicate)

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 (Hypothetical):
- Bench Testing: 50 units for electrical performance (impedance, SNR, drift). 10 units for durability.
- Biocompatibility: Standard number of animal samples as per ISO 10993.
- Clinical Use (if a new clinical study were required for substantial difference, not equivalence): 30 healthy volunteers and 20 patients (diagnosed with EMG-relevant conditions).
Data Provenance (Hypothetical):
- Bench Testing: In-house lab testing (United Kingdom).
- Biocompatibility: Third-party certified lab (e.g., USA).
- Clinical Use (if applicable): Prospective study conducted in a single neurology clinic in the UK.

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

Number of Experts (Hypothetical): 3 Neurologists/Clinical Neurophysiologists.
Qualifications (Hypothetical): Each expert would be a board-certified neurologist or clinical neurophysiologist with at least 10 years of experience in performing and interpreting EMG studies.

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

Adjudication Method (Hypothetical): For any subjective clinical assessments (e.g., signal quality grading, artifact presence, patient comfort), a consensus method would likely be used, where all 3 experts would independently assess and then meet to discuss and resolve any disagreements, reaching a final consensus. In some cases, if 2 of 3 agree, that might be taken, or a fourth adjudicator brought in (2+1, if 3 are primary readers). Given the nature of EMG, quantitative metrics are often primary, with experts providing qualitative input.

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:

MRMC Study: Not applicable to this device. This is a basic EMG electrode. MRMC studies are relevant for diagnostic algorithms (e.g., AI for image interpretation) where human readers interact with the output. This device is a passive sensor directly collecting physiological signals, not an interpretive AI system.

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

Standalone Study: Not applicable to this device. As above, this is a passive electrode, not an algorithm.

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

Ground Truth (Hypothetical):
- Electrical Performance: Established metrology standards and calibrated equipment (e.g., oscilloscopes, impedance meters).
- Biocompatibility: ISO 10993 standards and lab results.
- Clinical Performance (if applicable): Expert interpretation by the neurologists based on standard EMG diagnostic criteria, comparison against signals obtained from a legally marketed predicate device, and patient feedback.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is a passive electrode, not an machine learning or AI model that requires a training set.

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

Ground Truth for Training Set: Not applicable. As no training set is used.

In summary, the provided FDA 510(k) documentation for K981004 does NOT contain the details of acceptance criteria or a dedicated study because the device was cleared under the "substantial equivalence" pathway, meaning it was deemed as safe and effective as existing legally marketed predicate devices without requiring new performance evaluation studies explicitly documented in this summary.

Summary

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K 981004

SLE EMG Electrodes and Accessories

OCT 21 1998

510(K) SUMMARY

A. Manufacturer: Specialised Laboratory Equipment Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL United Kingdom
Ferguson Medical Submitted By: Consultant to Specialised Laboratory Equipment Limited
B. Contact Information: Phone : 44 181 681 1414 44 181 649 8570 FAX:
C. Classification Name: Electrode, needle, diagnostic electromyograph Common/Usual Name: Electrode, needle electrode, etc.
D. Classification Number: 89IKT

Proprietary Name:

E. Substantial Equivalence: Neuroline Disposable Concentric Needle Electrode, Medicotest A/S (K973529), Re-usable Concentric Needle, Chalgren (K953887), Re-usable Monopolar Needle, Ent., Inc. Chalgren Ent., Inc. (K953886), Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (K932059), Dantec Disposable Concentric Needle, Dantec Medical, Inc. (K931966), Disposable Monopolar Needle Electrode, Var Models, Chalgren (K912282), and Ent., Inc. EMG Electrodes and

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Extension Cords, Nihon Koden, Inc. (K870795), and others.

EMG Electrodes and Device Description: The SLE F. Accessories device consists of a variety of needle electrodes and accessories to be used in eletromyographic applications.
The SLE EMG Electrodes and Accessories G. Intended Use: device is intended to be used in recording muscle activity for electromyography applications.
Technological Characteristics: The design, materials, H. composition, packaging, and other chemical technological characteristics of the subject device are considered to be the same as the technological characteristics of the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Specialized Laboratory Equipment Limited Mr. Frank Ferguson Official Correspondent c/o Ferguson Medical 2581 California Park Drive, Suite 269 Chico, California 95928

Re: K981004 SLE EMG Electrodes and Accessories Trade Name: Regulatory Class: II Product Code: IKT July 6, 1998 Dated: Received: July 24, 1998

Dear Mr. Ferguson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

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Page 2 - Mr. Frank Ferguson

Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Whitton, Ph. D.

Witten, Ph.D., M.D. Celia M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10(k) Number (If known): K 98/00 4 SLE EMG Electrodes and Accessories Pevice Name: Indications For Use:

SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division of General Restorative Devices
510(k) Number K981004

rescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 890.1385 Diagnostic electromyograph needle electrode.

(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).