(28 days)
The Checkpoint Guardian Intraoperative Lead is a single-use, sterile medical device accessory intended to be used with Checkpoint Stimulators to provide electrical stimulation of exposed motor nerves or muscle tissue to identify nerves and to test nerve and muscle excitability.
The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.
The provided text describes a 510(k) premarket notification for the Checkpoint Guardian Intraoperative Lead, a medical device accessory. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a specific performance level of the new device itself through a diagnostic study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) is not available from this document. The document primarily details nonclinical testing to ensure the device's safety and functionality are equivalent to the predicate.
Here's an analysis based on the information provided, recognizing that it doesn't fit the typical diagnostic device evaluation framework:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, or accuracy) for the Checkpoint Guardian Intraoperative Lead. Instead, testing focused on engineering, safety, and compatibility standards. The "performance" is reported as meeting these standards.
| Acceptance Criteria Category | Specific Criteria (Implied from standards/testing) | Reported Device Performance |
|---|---|---|
| Functional/Electrical | Meet Checkpoint's mechanical & electrical specifications | All requirements met |
| Maintain electrical stimulation parameters/waveform (IEC 60601-2-10:2012+A1:2016 compliant) | Compliant | |
| Electrical Safety/EMC | Meet IEC 60601-1:2005 +A12013, IEC 60601-1-2:2014 standards | Meets system electrical design specifications and statutory regulations when used in conjunction with associated accessories |
| Biocompatibility | Conform to limits of BS EN ISO 10993-1:2018 (limited exposure) | All endpoints conforming to limits of BS EN ISO 10993-1:2018 and 2016 FDA guidance, and relevant biocompatibility endpoints met for wire/connector |
| Robustness/Design | Correct implementation of design intent and device robustness | Design Analysis and Evaluation Testing evaluated, ensuring correct implementation and robustness |
| Sterilization/Shelf Life | Maintain sterility via validated ETO cycle, achieve 2-year shelf life | Supplied Sterile via SAME validated and monitored ETO cycle; 2 Years Shelf Life |
| Packaging | Maintain integrity and functionality (same as stimulator) | Adopted into the same sterilization cycle as the stimulator; same sterile barrier system, sales, and shipping packaging used |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "a battery of bench and user tests" and "Design Verification Testing (DVT)" but does not specify the sample size (e.g., number of leads tested) for these tests. Data provenance, such as country of origin or whether it was retrospective/prospective, is not mentioned. It is implied these were internal, prospective engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the study was not a diagnostic study requiring expert ground truth for interpretation. The "ground truth" here would be established by validated engineering specifications and international standards, and results would be interpreted by qualified engineers and compliance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a diagnostic study involving human interpretation needing 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 device is an accessory for intraoperative nerve stimulation, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the nonclinical testing described was adherence to established industry standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility), internal design specifications, and functional performance requirements.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.