(113 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 provided document is a 510(k) Premarket Notification for the ATEC IOM Accessory Instruments. This document focuses on demonstrating substantial equivalence to predicate devices based on design, technology, and performance data, not clinical performance data. Therefore, the information typically required to describe acceptance criteria and a study proving a device meets these criteria in the context of clinical performance (e.g., sample size for test sets, expert adjudication, MRMC studies, ground truth establishment) is largely absent.
However, the document does contain information about performance testing for non-clinical aspects. Below is an interpretation of the available information in the context of your request.
Please note: The document explicitly states "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means that the study you are asking about, which would typically involve human subject data and clinical endpoints, was not conducted or submitted for this 510(k) clearance. The performance data presented refers to engineering and safety testing.
Acceptance Criteria and Device Performance (Non-Clinical)
The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test Category | Test Method Summary | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety Testing | Evaluation and testing in accordance with IEC 60601-1: 2005. | "All samples passed acceptance criteria" (Implicitly, compliance with IEC 60601-1) | All samples passed acceptance criteria |
| Reliability Testing | Testing to verify no adverse effect on safety or effectiveness based on intended environment and storage conditions. | "All samples passed acceptance criteria" (Implicitly, device remains safe and effective after reliability tests) | All samples passed acceptance criteria |
| Functional Performance Testing | Insulation Effectiveness; Electrical Resistance | "All samples passed acceptance criteria" (Implicitly, functional specifications for insulation and resistance met) | All samples passed acceptance criteria |
| Biocompatibility Testing | Per ISO 10993-1, including Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility. | "All samples passed acceptance criteria" (Implicitly, compliance with ISO 10993-1 for these endpoints) | Biocompatibility testing was conducted and data was leveraged (e.g., existing data, end-specific testing, Master File, predicate and reference devices, well known materials) to support biocompatibility. The conclusion states the device materials are "manufactured from the same materials as other legally US-marketed devices" and implicitly passed the evaluation. |
Information Regarding a Clinical Study (Not Applicable as per the Document)
As explicitly stated in the document, no clinical performance data was provided or relied upon for this 510(k) clearance. Therefore, the following points cannot be addressed from the given text as they pertain to clinical studies.
- Sample size used for the test set and the data provenance: Not applicable for a clinical study. For the non-clinical tests, the sample sizes are not specified beyond "All samples passed," meaning at least one sample was tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 instrument, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical ground truth. For non-clinical tests, the ground truth would be defined by the testing standards (e.g., IEC 60601-1, ISO 10993-1).
- The sample size for the training set: Not applicable for a clinical study. This device does not use a "training set" in the sense of machine learning.
- How the ground truth for the training set was established: Not applicable.
Summary of Device and Clearance Basis:
The ATEC IOM Accessory Instruments are surgical tools designed to assist in locating nerves during spinal surgical procedures. Their clearance (K191723) was based on substantial equivalence to existing legally marketed predicate devices, specifically K182617 (ATEC IOM Accessory Instruments) and K132138 (Rhythmlink Disposable Concentric Stimulating Probe).
The substantial equivalence was demonstrated through:
- Comparison of indications for use, design, function, and technology.
- Compliance with relevant electrical safety standards (IEC 60601-1).
- Reliability testing.
- Functional performance testing (insulation effectiveness, electrical resistance).
- Biocompatibility testing per ISO 10993-1, largely leveraging existing data and material characterization.
The crucial point is that this clearance did not involve a clinical performance study with human subjects, as the FDA determined it was not necessary to establish substantial equivalence for this type of device.
§ 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.