(159 days)
The Vertos Medical mild Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
The Vertos Medical mild Device Kit is a sterile, single-use device. The mild Device is composed of surgical tools consisting of one each of the following components: mild Initiator, mild Access Auger, mild Bone Rongeur, and mild Tissue Sculpter. The mild Initiator is pre-assembled for convenience and includes: the mild Trocar and Handle, mild Portal, mild Portal Grip, and mild Depth Guide. The mild Device Kit is utilized for tissue access, retraction, and resection within the lumbar spine via a minimally invasive posterior approach. The procedure is conducted percutaneously with the mild Tissue Sculpter and Bone Rongeur, placed through an introducer cannula, the mild Portal.
This document is a 510(k) Pre-market Notification for a medical device, specifically the Vertos mild Device Kit. It explicitly states that the device is a set of specialized surgical instruments and not an AI or software-driven diagnostic tool.
Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not applicable to this submission.
The "Performance Tests" section (VII) outlines the types of testing conducted for this surgical instrument kit, which focus on mechanical performance, safety, and sterility.
Here's a breakdown of the information that is present, aligning with the actual content provided:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table with specific numerical acceptance criteria and reported performance values for each criterion. Instead, it states that the device "met all predetermined acceptance criteria" for various performance tests. The performance is described qualitatively:
| Performance Test Category | Reported Device Performance |
|---|---|
| Simulated use cadaveric testing | Demonstrated the instruments can be used to safely and effectively perform the mild procedure. |
| Bench testing | Demonstrated the safety and efficacy of the instruments and their strength and integrity to resist impact, insertion, removal, and rotational loads to perform the stated intended use. |
| Shelf life and packaging testing | Demonstrated the safety and reliability of the labeled shelf life per ASTM F1886/F1886M, ASTM F2096, ASTM D4169, and ASTM F88/MF88. |
| Biocompatibility testing | Demonstrated the safety of the device per ISO 10993-1:2018. |
| Sterility Testing | Demonstrated the safety and effectiveness of the sterilization process per ISO 11137-1:2015 + A2:2019. |
| Particulate Testing | Demonstrated that the instruments do not produce foreign particulates during device interaction in excess of requirements per AAMI TIR42:2021. |
The following criteria are NOT applicable or NOT detailed in the provided document, as it pertains to a surgical instrument kit, not an AI/software device:
- Sample sized used for the test set and the data provenance: Not applicable in the context of AI/software test sets. The cadaveric testing implies a "sample size" of cadavers, but the number is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a surgical instrument is its mechanical function and safety, not diagnostic accuracy.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, ground truth is established through engineering and biocompatibility standards, and cadaveric performance, not medical consensus reads or pathology.
- The sample size for the training set: Not applicable (no AI/software training set).
- How the ground truth for the training set was established: Not applicable (no AI/software training set).
§ 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.