(48 days)
the Endius Endoscopic Access System is intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non-instrumented posterolateral fusion procedures.
Warning: The Endius Endoscopic Access System is not intended to be used for other types of fusion procedures such as posterior lumbar interbody fusions (non-instrumented or instrumented) or posterolateral fusions which employ instrumentation (pedicle screws/cages)
The Endoscopic Spinal Access System is a family of devices which are intended to be used to gain access and visualization to the spine in order to aid in various spinal procedures.
The provided text describes a 510(k) submission for the "Endius Endoscopic Spinal Access System." This document is a premarket notification for a medical device seeking clearance based on substantial equivalence to an existing device, not a study proving device performance against acceptance criteria in the way a clinical trial for an AI/ML device would.
Therefore, most of the requested information (items 1 through 9) related to a study proving device performance against acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission.
The 510(k) process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through comparison of device descriptions, indications for use, technological characteristics, and material compositions.
Here's a breakdown of what can be extracted from the provided text, while also explicitly stating what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document is a 510(k) summary demonstrating substantial equivalence, not a clinical study with predefined acceptance criteria and performance metrics. The "performance" assessment here is conceptual, comparing the new device's features and safety/effectiveness profile to that of a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of a clinical performance study described in this document. The submission relies on a comparison table to the predicate device.
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)
- Not Applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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 a surgical access system, not an AI/ML medical imaging device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to AI/ML algorithm performance, which is not relevant to this mechanical surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for performance evaluation is described. The "ground truth" for the 510(k) process is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set ground truth is discussed.
Information that is available from the provided text:
While the document doesn't fit the mold of an AI/ML device performance study, it does highlight the regulatory process for a physical medical device. Here's a summary of the relevant information provided:
- Device Name: Endius Endoscopic Spinal Access System
- Predicate Device: MicroEndoscopic Discectomy System (Sofamor Danek USA)
- Indications for Use: Posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy and non-instrumented posterolateral fusion procedures.
- Warnings/Limitations: Not intended for other types of fusion procedures such as posterior lumbar interbody fusions (non-instrumented or instrumented) or posterolateral fusions which employ instrumentation (pedicle screws/cages).
- Substantial Equivalence Justification: The document provides a "Table of Substantial Equivalent Device Similarities" comparing:
- Product Components: Both have Guidewire/Dilator Set, Tubular Retractor (or similar), Endoscope, Light Source, Camera and Control unit, and Flexible Arm Assembly (or similar).
- Product Labeling: Both are primarily Non-sterile, Reusable (with minor variations for specific components).
- Materials: Both are primarily Stainless Steel and Anodized Aluminum.
- Indications/Intended Use: Both are for accessing the lumbar spine for visualization and various spinal procedures. The Endius system specifies discectomy, nucleotomy, and non-instrumented posterolateral fusions.
The FDA's decision letter (FEB 16 2000) confirms that the device was found substantially equivalent to the predicate device for the stated indications for use, thereby allowing it to be marketed. This regulatory approval is the "proof" in this context, demonstrating that the device meets the safety and effectiveness standards by being comparable to an already approved device.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.