(15 days)
The Davol® ArthroVent™ Outflow Tubing is designed to control the amount of suction during arthroscopic procedures by controlling the amount of ambient air entering the outflow tubing set. It is for use with Davol's HydroFlex-AD Arthroscopic Distention System (reference 0025800, 0025200, 0025210), Arthro-Flo High Flow Irrigator (reference 0015000), and Gravity In-Flow Tubing Sets (reference 0088220, 0088240, and 0037870).
The proposed Davol® ArthroVent™ Outflow Tubing allows the user to regulate suction during arthroscopic procedures. It consists of two flexible suction connectors, flexible polyvinyl chloride (PVC) inlet and outlet tubes, and a suction regulator assembly. The variable control suction regulator assembly contains a one-way flapper valve, kidneyshaped main vent hole and secondary air channels. The secondary channels provide an alternate airflow path if the main vent were inadvertently obstructed. When the main vent is open, the suction regulator assembly allows ambient air into the system to reduce suction delivered to the operative site. As a user convenience, the outlet tube has a pinch clamp to close off suction.
This document describes the Davol® ArthroVent™ Outflow Tubing, an arthroscopic accessory designed to regulate suction during arthroscopic procedures. The provided text contains limited information regarding definitive acceptance criteria, and specific details about a formal study proving acceptance. However, based on the Performance Data section, we can infer the acceptance approach.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: Compliance with ISO 10993-1 requirements. | "The proposed ArthroVent Outflow Tubing will be compliant to the biocompability requirements pursuant to ISO 10993-1." (This is a statement of intent/expected compliance rather than a direct report of test results, but it implies this was an acceptance criterion). |
| Functional Equivalence: Performance similar to the predicate device (Stryker Suction Regulator) in regulating suction during arthroscopic procedures. This implies: | |
| a. Effective control of ambient air entry to modify suction. | |
| b. Functionality with specified inflow products (Davol's HydroFlex®-AD Arthroscopic Distention System, Arthro-Flo® High Flow Irrigator, and Gravity In-Flow Tubing Sets). | "Bench testing was performed to evaluate and compare the performance of the ArthroVent Outflow Tubing to the Stryker Suction Regulator using a simulated knee model and currently marketed inflow products. Results for both products were similar, which supports the substantial equivalence determination." (This broadly states performance parity, implying it met the functional equivalence criterion). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" using "a simulated knee model" and "currently marketed inflow products." However, it does not specify:
- The exact sample size (number of devices tested, number of runs, etc.) for the bench tests.
- The data provenance (e.g., country of origin, retrospective or prospective). This was a bench test, so geographical origin for "data" is less relevant than for clinical data, but the specifics of the test setup are missing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide any information about experts being used to establish a "ground truth" for the test set. The study described is a bench test comparing performance to a predicate, not a clinical trial requiring expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set
- Given that the study was a bench test comparing performance metrics, an adjudication method in the context of clinical interpretation (like 2+1 or 3+1 for expert consensus) is not applicable and therefore not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not conducted. The document describes a bench test, not a study involving human readers or clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a mechanical arthroscopic tubing product, not an AI algorithm or software. The "performance" being evaluated is the physical function of the tubing in regulating suction.
7. The Type of Ground Truth Used
- For the bench testing described, the "ground truth" would be objective physical measurements of characteristics like suction level, flow rate, or pressure generated/regulated, as compared to the predicate device. It's not expert consensus, pathology, or outcomes data in the usual medical device sense. The document states "Results for both products were similar," implying quantitative comparisons were made against predefined performance characteristics or established functional ranges.
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical medical device, not an AI model requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this 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.