(192 days)
The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.
The provided text describes the 510(k) summary for the EARP Nerve Cuff Electrode, a surgical nerve stimulator/locator. It does not pertain to an AI/ML medical device, but rather a physical medical device. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI/ML device's performance are not present in this document.
However, I can extract the information related to the acceptance criteria and the study that proves the physical device meets these criteria, based on the provided FDA 510(k) summary.
Here's an attempt to answer as much as possible given the limitations of the provided text, recognizing that it's for a traditional medical device, not an AI/ML one:
Acceptance Criteria and Device Performance for the EARP Nerve Cuff Electrode
Since this is a physical medical device submission, the "acceptance criteria" are based on non-clinical performance and biocompatibility testing, demonstrating the device's safety and effectiveness in its intended use, and its substantial equivalence to predicate devices. The "study" refers to the non-clinical testing performed.
1. A table of acceptance criteria and the reported device performance
The document lists "Summary of Non-Clinical Testing" which serves as the "study" proving the device meets the acceptance criteria. The acceptance criteria are implied by the "Conclusion" column (e.g., "no evidence of causing cell lysis or toxicity" for cytotoxicity), and the "Pass/Fail" column indicates whether the device met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (Conclusion) | Pass/Fail |
|---|---|---|
| Biocompatibility Testing: | ||
| Cytotoxicity (ISO 10993-5): No evidence of cell lysis or toxicity | The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity). | Pass |
| Sensitization (ISO 10993-10): No delayed dermal contact sensitization | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. | Pass |
| Irritation (ISO 10993-23): Acceptable difference in mean scores | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.1 for the SC and SO test article extracts, respectively. | Pass |
| Acute Systemic Toxicity (ISO 10993-11): No mortality or systemic toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. | Pass |
| Material-Mediated Pyrogenicity (USP, ISO 10993-11): Acceptable rise in rabbit temperatures | The total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP requirements. The test article met the requirements for the absence of pyrogens. | Pass |
| Other Non-Clinical Testing: | ||
| Dimensional characteristics, materials, function, intended use | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Tensile and flexural testing (mechanical integrity, continuity, isolation, visual appearance) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Electrical safety testing (high potential and electrical leakage per ISO 14708-1) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
| Electrode lead wire performance per 21 CFR 898.12 (IEC 60601-1) | Evaluated to ensure it performed as intended and supported substantial equivalence to predicate devices. (Specific performance values not detailed, but implied as 'Pass' overall.) | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of units, animals, or test replicates) for each test. It mentions "mice" and "guinea pig" for specific biocompatibility tests, implying the use of animal models according to the ISO standards.
- Data Provenance: The provenance is through laboratory testing conducted on the device components or extracts. The document does not specify the country of origin where the tests were performed, nor whether the data involved retrospective or prospective collection of patient data, as this is laboratory testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the type of device described. "Ground truth" established by experts is typically relevant for interpretative devices like AI/ML products where human experts provide labels or diagnoses for comparison. For a physical medical device like an electrode, the "ground truth" is established by adherence to recognized performance standards (e.g., ISO, IEC, USP) and validated laboratory test methodologies. The "experts" would be the qualified personnel performing and interpreting these specific laboratory tests.
4. Adjudication method for the test set
This concept is not applicable as there is no "adjudication" of human interpretations for this type of device. The results are based on objective measurements from standardized laboratory tests.
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
This concept is not applicable as this is not an AI/ML device, and no human reader study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as this is not an AI/ML device and does not involve an algorithm. The device's "standalone" performance is assessed through its physical characteristics and electrical/biocompatibility safety in laboratory settings.
7. The type of ground truth used
The "ground truth" for this physical device is established by:
- Established Performance Standards: Adherence to ISO, IEC, and USP standards for biocompatibility, electrical safety, and mechanical integrity.
- Objective Measurements: Laboratory measurements of physical, chemical, and electrical properties compared against pre-defined specifications derived from these standards or engineering requirements.
8. The sample size for the training set
This concept is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This concept is not applicable as this is not an AI/ML device that requires a training set.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.