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510(k) Data Aggregation
(88 days)
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
This 510(k) summary describes a submission for the Gemore IF True Sine Interferential Stimulator (Models GM3A001F/GM3A10IF/GM3A20IF/GM3A50IF). The submission aims to demonstrate substantial equivalence to a predicate device (Gemore IF TENS, Model GM322IF, K032719).
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define specific "acceptance criteria" in terms of measurable performance metrics and then report the device's achievement against these in a table format. Instead, it relies on demonstrating compliance with recognized standards and similarity to the predicate device to establish substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit) | Reported Device Performance/Evidence |
|---|---|---|
| Intended Use | Identical to predicate device | "The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain." This is stated as the intended use, and the submission claims it's the same as the cleared device. |
| Technological Characteristics | Output characteristics and controls identical to predicate device | "The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF have output characteristics and controls that are identical to those of the predicate device." |
| Safety - Electrical & EMC | Compliance with recognized electrical safety and electromagnetic compatibility standards | "Compliance to applicable voluntary standards includes ANSI/AAMI. NS4-1985, as well as IEC 60601-1, and IEC 60601-1-2 requirement." |
| Software Validation | Follow FDA software guidance | "In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance." |
| Differences from Predicate | Changes do not affect intended use or alter fundamental scientific technology. | Differences noted: new housing design, firmware/software/operation interface change (digital to analog), maximum intensity adjustment range changed from 60mA to 70mA, operation modes reduced from 9 to 4. Conclusion: "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device. In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device." |
2. Sample Size Used for the Test Set and the Data Provenance
The summary does not provide details on a specific "test set" in the context of clinical or performance data for the device. The testing mentioned largely refers to engineering verification and validation against standards and comparisons to the predicate device's specifications. Thus, there is no disclosed sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical or performance "test set" in the sense of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the submission. The submission focuses on substantial equivalence through engineering changes and compliance with standards, not on clinical performance evaluated against expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided. As there is no clinical or performance "test set" with ground truth established by experts discussed, an adjudication method is not applicable here.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a stimulator, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance study, typically for AI or software-based diagnostic devices. The Gemore IF stimulator is a physical electrical stimulation device. While it has firmware/software, the primary "performance" is the electrical output. The summary indicates "software verification has been carried out according to the FDA software guidance," but this is about the software itself functioning correctly, not about a standalone clinical performance evaluation of an algorithm in the sense of AI.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to diagnostic or prognostic devices is not directly applicable or detailed in this submission. The "truth" for this submission revolves around:
- Compliance with engineering standards: The device's electrical output and safety features meet established international and voluntary standards (e.g., ANSI/AAMI. NS4-1985, IEC 60601-1, IEC 60601-1-2).
- Verification of software functionality: The software operates according to design and FDA guidance.
- Substantial equivalence to the predicate: The device's intended use and fundamental technological characteristics are equivalent to the previously cleared predicate device, despite stated modifications.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is an electrical stimulator, not a machine learning or AI-based device that would typically involve a "training set" for model development.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As there is no AI/ML component with a training set, the establishment of ground truth for such a set is not relevant to this submission.
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