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510(k) Data Aggregation
(63 days)
Spes Medica Subdermal Needle Electrodes
Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
Spes Medica Subdermal Needle Electrodes are monopolar needles intented to use for Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals in example and they are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. The Subdermal Needle Electrodes are used for recording and stimulation (micro stimulation), this stimulation has no therapeutic purpose but has the purpose of activating an electrical response.
The provided text describes the acceptance criteria and performance testing of the Spes Medica Subdermal Needle Electrodes, but it largely focuses on biocompatibility, sterilization/packaging, and electrical safety standards rather than a comparative effectiveness study involving human readers or AI.
Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale clinical data will not be present in this document.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Description/Standard) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5) | No reactivity |
| Skin Irritation (ISO 10993-10) | Negligible irritation response |
| Hemolysis test (ISO 10993-4) | Does not cause hemolysis |
| Skin Sensitization (ISO 10993-10) | Not sensitizing |
| Systemic Toxicity (ISO 10993-11) | No toxic symptoms, satisfies requirements |
| Pyrogenicity test (ISO 10993-11) | Meets requirements for absence of pyrogens |
| Sterilization/Packaging | |
| Packaging Validation Protocol (5 years shelf-life) | No substantial alterations after aging process, devices remain sterile (Tested against ASTM D4332, ASTM D4169, ISO 11135-1, 11737-1, 11737-2) |
| Packaging validation test (Sterility test) | All samples met seal strength requirements per ASTM F88 |
| Electrical Safety | |
| Electrical Safety - Isolation (IEC 60601-1: 3rd Ed + CORR 2:2007 + A1:2012 clause 8.5.2.3) | Isolated and in compliance with requirements for electrically safety |
| Impedance test and dielectric strength | Stimulation doesn't affect or reduce the needle and its performance |
| Physical Performance | |
| Cable tensile testing | Very high strength force (average 40.1 N) during pull-out test, ensuring manufacturing process safety and strength of use |
| Shipment Tests (Handling, Vehicle Stacking, Loose Load Vibration, Vehicle Vibration, Concentrated Impact) | No damage to the product observed |
| Climatic Tests (Changing temperature and relative humidity) | No damage to the product observed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify general "test sets" or data provenance in the way one would for an AI or clinical study. The performance tests are laboratory-based and conducted on the device components or prototypes. The sample sizes for each specific test (e.g., number of units tested for tensile strength, number of samples for biocompatibility) are not explicitly stated, nor is the country of origin or whether they were retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes performance testing for a medical device to establish its safety and effectiveness based on international standards, not the establishment of ground truth by clinical experts for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic study requiring expert adjudication.
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 document does not describe an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the various performance tests, the "ground truth" is defined by the requirements of the international standards (e.g., ISO, ASTM, IEC) that the device must meet. For biocompatibility tests, it's the biological response against established thresholds; for electrical safety, it's adherence to voltage and isolation limits; for mechanical tests, it's resistance to forces.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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