(72 days)
The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories to the Lorenz Biotech Aptiva™ and are intended to be used for electrical stimulation. They are non-sterile and for single patient use only.
The Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes are accessories for Lorenz Biotech Aptiva™. The silver/silver chloride conductors are covered with Apti-Gel, a medical hydrogel coupling agent. The FREMS™ SSC Disposable Electrodes are provided with either foam or non-woven backing in sealed pouches of 30 electrodes.
The provided text is a 510(k) summary for the Lorenz Biotech S.p.A. FREMS™ SSC Disposable (Foam and Non-Woven) Electrodes. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain details about specific acceptance criteria, a formal study design with sample sizes, expert qualifications, or ground truth establishment in the way typically expected for a medical device performance study, especially for complex algorithms or diagnostic tools.
Instead, the "Performance Testing" section states: "Performance testing of the FREMS™ SSC Disposable Electrodes demonstrates that they meet prospectively defined design and performance specifications. Side-by-side testing of impedance demonstrates comparable results to those obtained with the predicate devices."
This indicates that the acceptance criteria are likely related to electrical impedance and the study involved a comparative test with predicate devices. Without further details, specific numerical acceptance criteria or performance metrics are not provided.
Given this limitation, I will extract the available information and indicate where specifics are missing.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific criteria not explicitly stated beyond meeting "prospectively defined design and performance specifications." | "Side-by-side testing of impedance demonstrates comparable results to those obtained with the predicate devices." |
| Likely criteria related to electrical impedance characteristics suitable for "cutaneous stimulation electrodes" (as inferred from the device classification and intended use). | The device's impedance "demonstrates comparable results to those obtained with the predicate devices" (NeuroEase, Snap Ease). |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document generaly refers to "side-by-side testing of impedance."
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): "Prospectively defined design and performance specifications" suggests a prospective approach to defining criteria, but the nature of the impedance testing itself (e.g., in vitro, ex vivo, in vivo) and its specific origin are not detailed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. For a device like electrodes, "ground truth" would typically refer to established technical standards or physical measurements (e.g., using calibrated equipment to measure impedance), rather than expert clinical consensus.
- Qualifications of Experts: Not applicable/not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not specified. Adjudication methods are typically used for interpreting image or clinical data where human judgment is involved, which is not described for this impedance testing.
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human interpretation, which is not the function of these electrodes.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. This device is an accessory (electrodes) for electrical stimulation, not an AI algorithm. The performance evaluation focuses on its physical and electrical properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for impedance testing would likely be technical measurements against established standards or direct comparisons with the measured performance of legally marketed predicate devices, as implied by "comparable results to those obtained with the predicate devices." It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a "training set."
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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 Device Safety and Effectiveness Demonstration:
The approval of the Lorenz Biotech S.p.A. FREMS™ SSC Disposable Electrodes (K080902) appears to be based on demonstrating substantial equivalence to existing predicate devices (NeuroEase, Snap Ease) in terms of:
- Intended Use: Used for electrical stimulation.
- Indications for Use: Same as intended use.
- Operational Characteristics: Implied to be similar.
- Fundamental Technological Characteristics: Described as "silver/silver chloride conductors covered with Apti-Gel" with foam or non-woven backing, similar to predicate devices.
- Performance Characteristics: Demonstrated through "side-by-side testing of impedance" showing "comparable results" to the predicate devices. This suggests that the impedance of the new electrodes falls within an acceptable range or is statistically equivalent to the impedance of the predicate devices, which are deemed safe and effective for their intended use.
The 510(k) pathway relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate. For accessories like these electrodes, technical performance data (like impedance) demonstrating similarity to approved devices is the primary evidence provided, rather than extensive clinical efficacy studies or complex AI validation methods.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).