(84 days)
An arthroscopic blade is indicated for resection of soft and osseous tissues in articular cavities. Use of the device within paranasal sinuses (Funtional Endoscopic Sinus Surgery [FESS]) is limited to appropriately small blades (3.5 mm).
Arthroscopic blades, when coupled with a compatible arthroscopic hand-piece and motorized control console, are used to resect soft and osseous tissue in articular cavities. An arthroscopic blade is designed as a "tube within a tube". A smaller diameter inner sleeve rotates within a larger diameter outer sleeve. The outer diameter and contour of the inner sleeve closely matches the inner diameter and contour of the outer sleeve. The distal end of the outer sleeve has an approximately half-diameter cut-out that acts as a hold and shearing edge for the cutting action of the inner sleeve. Depending upon the model, the distal end of the inner sleeve is commonly referred to as a shaver or burr. The distal tip of a shaver inner sleeve has a half-diameter cut-out with sharpened edges or serrated teeth and is designed for cutting tissue. The distal tip of a burr inner sleeve is a series of axially elongated, inclined cutting edges ("flutes") space circumferentially around the distal tip and is typically used for abrading bone. At their proximal ends, both sleeves are mounted within molded plastic hubs that couple with the hand-piece of their compatible programmable motorized control console ("drive unit"). Neither the hand-piece nor the drive unit is reprocessed by Vanguard. The outer sleeve hub is designed to engage and lock into the OEM proprietary motorized hand-piece and to provide a water tight seal with the hand-piece housing. Depending upon the OEM, the seal is provided by an elastomeric sealing ring installed on the hub or in the hand-piece housing. The inner sleeve hub is designed to rotationally engage the shaft coupling of the hand-piece motor and to provide means for spring-loading the distal end of the inner sleeve against the distal end of the outer sleeve. The inner sleeve hub has an open port to the proximal end that connects with a fluid line in the hand-piece. This allows fluid to be aspirated from the surgical site through the inner rotating sleeve. The fluid, typically and isotonic saline solution, is intended to remove severed tissue and to cool/lubricate the distal cutting ends of the arthroscopic blade. The drive unit may run clockwise, counter-clockwise or in an oscillatory mode, typically at 100 - 3000 rpm in the uni-directional mode and up to 1500 rpm in the oscillatory mode. Vanguard receives previously used arthroscopic shavers, burrs and blades from healthcare facilities; cleans, refurbishes (if necessary, sharpens), inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
This document is a 510(k) Summary of Safety & Effectiveness for reprocessed arthroscopic blades, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample sizes for test/training sets, ground truth establishment methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from the provided text.
However, I can extract the acceptance criteria and the general study types mentioned for this medical device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs as intended. | Functional/performance testing demonstrates that the reprocessed devices perform as intended. |
| Device is safe and effective. | Sterilization and packaging validations, functional/performance, pyrogenicity and biocompatibility testing demonstrate that the reprocessed devices are safe and effective. |
| Substantially equivalent to predicate devices. | Based on the provided information and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, the reprocessed arthroscopic blades are substantially equivalent to the predicate devices. |
Study Information (Based on available text for a reprocessed medical device)
- Sample sizes used for the test set and the data provenance: Not specified for individual tests. The document only mentions "reprocessed devices" generally. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for this type of device submission.
- 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 reprocessed medical device primarily relies on objective physical and chemical testing parameters, rather than expert interpretation of data in the way an AI/ML device would.
- Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert interpretations of medical data, which is not the primary testing methodology for reprocessed surgical blades.
- 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 not an AI/ML device; it's a reprocessed surgical tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used:
- Performance/Functionality: Likely established through physical testing against OEM specifications (e.g., sharpness, rotational speed tolerance, aspiration effectiveness, durability).
- Sterilization: Established by microbiological testing standards to ensure sterility.
- Biocompatibility: Established by testing against ISO standards for biological evaluation of medical devices (e.g., cytotoxicity, irritation, sensitization).
- Pyrogenicity: Established by testing for the absence of pyrogens.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Summary of the Study that Proves Device Meets Acceptance Criteria:
Vanguard Medical Concepts, Inc. performed various tests to demonstrate the safety and effectiveness of their reprocessed arthroscopic blades, confirming their substantial equivalence to predicate OEM devices. The key studies supporting this conclusion include:
- Sterilization and Packaging Validations: These studies demonstrated that the reprocessing methods successfully sterilize the devices and maintain the integrity of their packaging.
- Functional/Performance Testing: These tests confirmed that the reprocessed blades perform their intended functions as designed (e.g., resection of soft and osseous tissues) and meet relevant engineering specifications.
- Pyrogenicity Testing: This testing ensures the absence of fever-inducing substances on the reprocessed devices, contributing to patient safety.
- Biocompatibility Testing: These tests demonstrated that the materials of the reprocessed devices are compatible with biological systems and do not cause adverse reactions in the body.
The totality of these tests indicated that the reprocessed devices performed as intended and remained safe and effective for their indicated use, thus meeting the acceptance criteria for substantial equivalence to the predicate devices.
§ 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.