(18 days)
The Endius® FlexTip® Blade is an articulating soft tissue resector designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies.
The Endius FlexTip Blade is a disposable, articulating soft tissue resector designed to be used as an accessory to the Arthroscopic Micro-Discectomy (AMD) System or compatible drive systems. The FlexTip Blade has a flexible portion near the tip, allowing the tip to articulate under control of the lever in the handle. The inner shaft rotates inside the outer shaft providing cutting action through an aperture at the tip. Resected material is suctioned through the inner shaft and shaver handle into an inline external tissue trap. The Endius FlexTip Blade is sold sterile for single-use only.
This 510(k) submission for the Endius® FlexTip® Blade is for a medical device cleared in 2002. At that time, the requirements for demonstrating substantial equivalence were different from those for AI/ML-enabled devices today. This submission primarily focuses on comparing the new device to a predicate device based on design, materials, and intended use, rather than extensive performance studies with quantitative metrics on diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment (which are standard for AI/ML device submissions) are not present or applicable in this document.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is unavailable due to the nature of this type of medical device submission:
1. Table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for the Endius® FlexTip® Blade. The clearance is based on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined quantitative performance targets from a clinical study.
2. Sample size used for the test set and the data provenance
No test set, in the experimental sense for assessing AI/ML model performance, is mentioned in this document. The clearance is based on a comparison to a predicate device, focusing on design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical surgical tool, not a diagnostic AI/ML system requiring expert-established ground truth for performance evaluation.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this device.
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 is a mechanical surgical tool, not an AI-assisted diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of medical device, "ground truth" in the context of AI/ML evaluation metrics is not relevant. The substantial equivalence is based on comparing the physical and functional characteristics to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth in the context of an AI/ML model.
Summary of the Study (or lack thereof, in the AI/ML context):
The provided document describes a 510(k) Premarket Notification for the Endius® FlexTip® Blade. The "study" described, relevant to a medical device from 2002, is a demonstration of substantial equivalence to a predicate device, the Endius Endo-Bend Shaver System (K950054).
The acceptance criteria for this submission are implicit in the FDA's "substantial equivalence" determination. This means the new device (Endius® FlexTip® Blade) must be shown to be as safe and effective as a legally marketed predicate device. This is typically achieved by demonstrating:
- Same intended use: The document states both devices are "articulating soft tissue resector(s) designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies."
- Same technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness: The new device is described as having a "flexible portion near the tip, allowing the tip to articulate under control of the lever in the handle," which is an evolution from the predicate. The submission would have focused on justifying that this design change does not introduce new risks or reduce effectiveness, likely through engineering analysis, material testing, and potentially bench testing of the cutting action or articulation mechanism.
The document does not detail specific performance studies with quantitative outcomes (like accuracy, sensitivity, etc.) on human subjects or datasets, as would be required for AI/ML devices. Instead, it relies on the comparison to a previously cleared device. The "proof" that the device meets "acceptance criteria" is the FDA's letter stating that the device is "substantially equivalent" to the predicate.
§ 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.