ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C by MED LABS, INC.

First, we wish to change the type of battery from a 67.5 volt to a 9 volt.
Second, we are changing the electrode connectors from .080" pin plugs and pin jacks to a safer design as recommended by the F.D.A.. The new connector will be a 3.5mm right angle phone plug, which is physically too large to fit into a standard 120 volt outlet.
The third change will add a new circuit to limit the on-time (Pulse Width) and duty cycle in the Interrupted D.C. (Galvanic) mode.

AI/ML Overview

This document is a 510(k) summary for the EMS-1C and EMS-2C electrical muscle/neuromuscular stimulators, dated January 22, 1996. It details the device's background, description of changes from previous models, and claims of substantial equivalence.

Based on the provided text, the device is an Electrical Muscle/Neuromuscular Stimulator, and the document describes changes to existing devices (EMS-1A and EMS-2A) rather than a study proving the device meets specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text. The document is essentially a submission explaining minor design changes to a previously "grandfathered" device, arguing for its substantial equivalence without presenting new performance studies or acceptance criteria for those changes.

Here's an attempt to answer what can be extracted from the text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
No specific quantitative acceptance criteria or performance metrics are provided for the new models (EMS-1C/EMS-2C) in this document.	The document primarily states that the new versions will maintain the original specifications, safety, and efficacy of the pre-amendment "grandfathered" devices (EMS-1A/EMS-2A) while incorporating minor technological improvements.

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

Not applicable. The document does not describe a new study with a test set. It describes minor design changes to an existing device.

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

Not applicable. No ground truth establishment for a new test set is described.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication method 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 is an electrical muscle stimulator, not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This is an electrical muscle stimulator; it does not involve algorithms or human-in-the-loop performance in the context of AI.

7. The type of ground truth used:

Not applicable. No new ground truth is established as no new performance study is detailed. The substantial equivalence is based on the existing efficacy and safety of the "grandfathered" devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this device is not an AI/machine learning product and no new performance study is detailed.

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

Not applicable. No training set or ground truth establishment is mentioned.

Summary of what the document DOES state regarding "acceptance" and "proof":

The core of this 510(k) submission is to establish Substantial Equivalence to legally marketed predicate devices (EMS-1A and EMS-2A).

Acceptance Criteria (Implicit): The implicit acceptance criteria are that the modifications (battery change, connector change, pulse width limit) do not alter the fundamental safety and effectiveness of the device as established by the pre-amendment "grandfathered" predicate devices. The changes are intended to be "minor" and "technological improvements" that either enhance convenience, improve safety, or maintain existing specifications.
Proof: The "proof" is largely by assertion and logical deduction:
- Battery Change: "This change is for the convenience of our customers, and will not have any effect on the specifications, safety, or efficacy." (Assertion)
- Connector Change: Based on an FDA recommendation for a safer design, implying an improvement in safety without affecting efficacy. "It is not necessary to wait for 510(k) approval before making this change. However, we should notify the F.D.A. when we make the change."
- Pulse Width/Duty Cycle Limiter: "This change will also have no efficacy, since it will simply prevent the user from delivering a wider pulse than is recommended in the current instructions. It will, however, improve safety and comfort." (Assertion and safety improvement).

The document is a request for the FDA to acknowledge that the EMS-1C and EMS-2C are "substantially equivalent in efficacy and safety" to the existing, "grandfathered" models, based on shared "equipment, specifications, indications, and contraindications, with improved technology." They are not presenting new clinical or performance data to meet novel acceptance criteria, but rather arguing that the existing safety and efficacy profile a applies to the slightly modified devices.

Summary

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MED LABS, INC

28 Vereda Cordillera, Goleta, California 93117

510 (k) SUMMARY: EMS-1C / EMS-2C

JANUARY 22, 1996

K960457

Contact Person: Philip D. Norvell, Chief Engineer

SEP - 6 1996

· Proprietary Names: EMS-1C and EMS-2C
· Common Name: Electrical Muscle/Neuromuscular Stimulator
· Classification Name: Stimulator, Muscle, Powered

Background: The EMS-2A is capable of both Interrupted Direct Current and Pulsed stimulation. The EMS-1A is identical, except that it is only capable of Interrupted D.C. stimulation. Both models have been marketed by Med Labs, since 1969. We are planning the release of two new versions of these instruments, at as early a date as possible. The new versions will be called the EMS-1C and the EMS-2C.

Description: The new versions will incorporate three changes, all of which we believe to be minor, and may be accurately described as technological improvements.

1. First, we wish to change the type of battery from a 67.5 volt to a 9 volt. This will make battery replacement much easier and much less expensive for our customers. Initially, several companies made the 67.5 volt battery, but now, it is only available from Eveready. In addition, Eveready has recently increased the price of this battery by about 80%. It is now more cost-effective to use a D.C. to D.C. Converter powered by an inexpensive and readily available 9 volt battery.
  This change is for the convenience of our customers, and will not have any effect on the specifications, safety, or efficacy.
1. Second, we are changing the electrode connectors from .080" pin plugs and pin jacks to a safer design as recommended by the F.D.A.. The new connector will be a 3.5mm right angle phone plug, which is physically too large to fit into a standard 120 volt outlet. In an F.D.A. letter from Susan Alpert, M.D., Ph.D., Director, Office of Device Evaluation, dated February 15, 1995, manufacturers were told that it is not necessary to wait for 510(k) approval before making this change. However, we should notify the F.D.A. when we make the change.
1. The third change will add a new circuit to limit the on-time (Pulse Width) and duty cycle in the Interrupted D.C. (Galvanic) mode. This will prevent a user from exceeding the recommended ontime. This in turn, will limit the RMS current and power dissipated in the patients skin and surrounding tissue, and therefore keep the skin irritation to a minimum.

This change will also have no efficacy, since it will simply prevent the user from delivering a wider pulse than is recommended in the current instructions. It will, however, improve safety and comfort.

NOTE: With the EMS-1A and EMS-2A, the pulse width and duty cycle in the Interrupted D.C. mode are manually controlled (by how long the user presses the switch). Our current instruction manual states that the push-button switch should be pressed for about 1/4 second.

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510 (k) SUMMARY: EMS-1C / EMS-2C

Substantial Equivalence: These units are substantially equivalent in efficacy and safety to the Powered Muscle Stimulators which MED LABS, Inc. currently markets, since they are based on the same equipment, specifications, indications, and contraindications, with improved technology.

COMPANY MED LABS, Inc. MED LABS, Inc. PRODUCT EMS-1/EMS-1A EMS-2/EMS-2A

510K NUMBER "Grandfathered"

"Grandfathered"

NOTES Pre-amendment Device Pre-amendment Device

We request that the EMS-1C be accepted as equal in safety and effectiveness to the above equipment.

If you have any questions or require further documentation, please feel free to call us at (805) 968-2486.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).