(92 days)
The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user.
The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating.
The provided document is a 510(k) summary for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing. It does not describe an acceptance criteria and study proving device meets acceptance criteria in the context of clinical performance or accuracy of an AI/ML device.
Therefore, I cannot extract the specifically requested information regarding acceptance criteria and study details as they pertain to such a device type because this information is not present in the provided document.
The document discusses:
- Manufacturing and material equivalence: The new dilators are made of conductive silver ink, aluminum alloy, and dielectric coating and are compared to existing predicate devices.
- Performance testing (non-clinical): This includes electrical safety testing (IEC 60601-1), functional performance testing (insulation effectiveness and electrical resistance), and reprocessing validation. All samples passed acceptance criteria for these tests.
- Biocompatibility testing: Evaluated per ISO 10993-1 for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.
None of these tests involve "device performance" in terms of clinical accuracy, AI/ML output, or human-in-the-loop effectiveness.
However, I can extract the information that is present about the non-clinical performance testing:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety Testing and/or Evaluation | In accordance with IEC 60601-1: 2005(R)2012 | All samples passed acceptance criteria |
| Functional Performance Testing and Verification | Not explicitly stated, but includes: | All samples passed acceptance criteria |
| - Insulation Effectiveness | - Meets functional requirements (implied by passing) | |
| - Electrical Resistance | - Meets functional requirements (implied by passing) | |
| Reprocessing | Cleaning validation or adoption study based on AAMI | All samples passed acceptance criteria |
| TIR30:2011 | ||
| Steam sterilization validation or adoption performed | ||
| per ANSI/AAMI/ISO 17665-1:2006/(R)2013 |
2. Sample size used for the test set and the data provenance: Not applicable. The tests mentioned are laboratory-based electrical, functional, and reprocessing tests, not clinical studies with patients or data sets with provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and sterilization tests, not expert-adjudicated clinical assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical or image-based adjudication, not engineering 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: Not applicable. This device is an accessory instrument, not an AI/ML diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory instrument, not an AI/ML algorithm.
7. The type of ground truth used: Not applicable in the context of clinical accuracy or AI performance. For the engineering tests, "ground truth" would be the specifications and requirements of the applicable standards (e.g., IEC 60601-1, AAMI TIR30, ANSI/AAMI/ISO 17665-1).
8. The sample size for the training set: Not applicable. This device is not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML product.
§ 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.