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510(k) Data Aggregation
(227 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).
The document provided is a 510(k) premarket notification for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, functionality, and performance testing. However, it explicitly states:
"Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This means the submission does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human-in-the-loop studies involving AI. The acceptance criteria and performance data provided are related to functional, electrical safety, biocompatibility, and reprocessing aspects of the surgical instruments themselves, not their performance in a clinical diagnostic or prognostic context with AI assistance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/clinical performance study.
The document covers the following types of acceptance criteria and proven performance for the ATEC IOM Accessory Instruments (which are surgical tools, not an AI diagnostic device):
1. Table of Acceptance Criteria and Reported Device Performance (Summary of Engineering/Safety Tests):
| Test | Acceptance Criteria (Implied by Test Method) | Reported Device Performance |
|---|---|---|
| Functional performance testing and verification analysis | Insulation Effectiveness, Electrical Resistance, Current Density (as per standard engineering principles for electrical stimulation instruments) | "All functional performance testing passed. Substantial equivalence has been shown via analysis and testing." |
| Electrical safety testing and/or evaluation | Compliance with IEC 60601-1: 2005 for medical electrical equipment. | "Subject devices passed electrical safety testing and/or evaluation, demonstrating that the devices meet the requirements." |
| Biocompatibility testing | Compliance with ISO 10993 for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility. Risk analysis performed considering body contact and duration. | "A risk analysis was performed taking into account nature of body contact and duration to categorization the use of existing data, end-specific testing, and endpoint assessment to cover the identified test methods. Additionally, data was leveraged by other means (e.g., authorized use of Master File, predicate and reference devices, well known and characterized materials) to support the biocompatibility of the subject devices." |
| Reprocessing (Cleaning and Sterilization) | Cleaning validation study based on AAMI TIR30:2011 acceptance criteria. Steam sterilization validation performed per ANSI/AAMI/ISO 17665-1:2006/(R)2013 to assure an SAL of 10^-6. | "The subject devices can be adequately cleaned and steam sterilized prior to use." |
The document does NOT provide information for the following points, as they are not relevant to a device submission for surgical instruments focused on substantial equivalence based on material and functional safety rather than AI performance:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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(134 days)
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The provided text describes the Alphatec Navigation Instruments and its 510(k) submission for market clearance. While it outlines the device's intended use, comparison to a predicate device, and general performance data, it does not provide detailed acceptance criteria or a specific study proving the device meets those criteria with the level of detail requested in the prompt.
The document states that "Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance." It mentions "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment," but does not provide the quantitative results or specific criteria for acceptance.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the available information, with notations where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (as stated in the document) |
|---|---|
| Accuracy: (Specific quantifiable target e.g., |
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