FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

. Relaxation of muscle spasms
Prevention or retardation of disuse atrophy .
. Increasing local blood circulation
. Muscle re-education
. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion. .

For TENS waveform:

Relief of chronic, intractable pain .
Adjunctive treatment of post surgical or post traumatic acute pain .

Device Description

The COMBI family by CEC, is a line of multi-wave pulse generators, intended for medical purposes.

The COMBI generators are capable of producing different wave types, such as: three Russian currents (1:1, 2:1, 4:1), symmetric TENS, and symmetric in burst mode: asymmetric TENS, and asymmetric in burst mode; bipolar interferential; three types of impulses, rectangular, triangular, exp + direct current.

The devices deliver the predetermined electrical pulses through skin contact adhesive clectrodes, connected to up to four or eight independent body channels, depending on the specific model. (The prefixes 4 and 8 designate the number of channels, respectively).

Three different configurations of Multiwave Generator devices comprise the COMBI product line:

1. COMBI Digital
1. COMBI Trend
1. COMBI Max

AI/ML Overview

This document describes the regulatory submission for the CEC Electronica S.R.L. COMBI 8 MAX, a powered muscle stimulator. The information provided heavily focuses on regulatory compliance and substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study and its findings cannot be fully addressed from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for the device's clinical performance, nor does it present device performance data from a clinical study against such criteria. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices by comparing technological characteristics and intended use.

Acceptance Criteria (Explicitly Stated in the Document)	Reported Device Performance (as described for COMBI 8 MAX)
Intended Use identical to predicate devices.	COMBI 8 MAX has the same intended uses as the predicate devices (relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles, maintaining/increasing range of motion, and for TENS waveform: relief of chronic/intractable pain, adjunctive treatment of post-surgical/post-traumatic acute pain).
Fundamental scientific technology identical to predicate devices.	The device is a multi-wave pulse generator that produces various wave types (Russian currents, TENS, interferential, impulses, direct current) through skin contact electrodes, similar to predicate devices. Technological characteristics were provided and compared.
Modifications relative to predicate devices do not introduce any new hazards and do not affect mitigations and CAPA.	The submission asserts that modifications are adequately described and do not introduce new hazards.
Compliance with recognized standards (e.g., electrical safety).	The device is in compliance with IEC 60601-2-10 (1987-12) for medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators.
Labeling compliant with FDA guidance.	Device labeling was prepared according to Attachment II - Labeling guidance.
Software validation performed using FDA guidance.	Software validation was performed using the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

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

No clinical test set is described. The submission relies on a comparison of technological characteristics to predicate devices. There is no mention of a patient-based test set, its sample size, or its provenance.

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

Not applicable, as no clinical test set with a ground truth established by experts is described. The "ground truth" in this context refers to the technological specifications and safety standards defined by regulatory bodies and previous predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring 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:

Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study with human readers improving with AI assistance is not relevant to this submission.

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

Not applicable. The COMBI 8 MAX is a physical medical device, not an algorithm. Its performance is inherent in its design and ability to generate specific electrical pulses based on pre-programmed settings and user interaction.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this submission is established through regulatory standards, predicate device characteristics, and the documented scientific understanding of electrical stimulation for therapeutic purposes. It's based on:

FDA Guidance Documents: Such as the "Guidance Document for Powered Muscle Stimulator 510(k)s."
Recognized Standards: Like IEC 60601-2-10.
Predicate Device Compliance: The assumption that the predicate devices (K984114, K062354, K960969) are safe and effective.
Scientific Principles: The understanding of how various electrical waveforms affect muscle and nerve tissues.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that would require 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.

Summary of the Study (Based on Provided Information):

The submission for the COMBI 8 MAX is a 510(k) premarket notification aiming to demonstrate substantial equivalence to predicate devices. The "study" described is primarily a regulatory and technical comparison study, not a clinical efficacy trial in the traditional sense for this specific 510k submission.

The applicant provided:

A comparison of the device's technological characteristics (wave types, channels, outputs) to those of the predicate devices.
An assertion that the intended use is identical to the cleared predicate devices.
Documentation of compliance with relevant recognized standards (e.g., IEC 60601-2-10 for electrical safety).
Evidence that labeling and software validation procedures followed FDA guidance.

The "proof" that the device meets "acceptance criteria" (which are largely regulatory and technical in this context) is therefore based on this comprehensive comparison and adherence to established guidelines, demonstrating that it is as safe and effective as existing legally marketed devices without raising new questions of safety or effectiveness. There is no mention of a specific clinical trial conducted for this 510(k) submission to prove clinical efficacy against predefined acceptance criteria. Instead, the assumption of efficacy and safety is derived from its substantial equivalence to already approved devices.

Summary

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).