(25 days)
The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the InstaTrak Receiver. The Sinus Guide Adapter is used in conjunction with a Calibration Device that is compatible with the InstaTrak Navigation system. The Calibration Device is used to calibrate the tip position and the trajectory line of the Sinus Guide Catheter. Once calibrated, the Calibration Device is removed.
The Acclarent ReliENT™ Navigation Device is an accessory to the Sinus Guide Catheter, enabling navigation capability for diagnostic and therapeutic procedures in the sinus space.
Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter and Calibration Device met all performance testing acceptance criteria." However, specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) and their corresponding reported device performance values are not detailed in the provided text. The submission focuses on substantial equivalence based on meeting all general performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All performance testing criteria | Met all criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly refers to "performance testing" being conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information about the number of experts, their qualifications, or how ground truth was established for the specific performance tests.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No effect size of human readers improving with AI vs. without AI assistance is provided, as this device does not appear to involve AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an AI algorithm but a physical accessory for a navigation system. Therefore, a standalone algorithm-only performance study would not be applicable. The performance testing would relate to the physical and functional aspects of the adapter and calibration device.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance testing. Given the nature of a navigation device accessory, the ground truth would likely involve physical measurements and system accuracy assessments against known standards or reference points. It would not typically involve expert consensus, pathology, or outcomes data in the same way an image analysis algorithm would.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a physical medical device (an accessory for a navigation system), not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML algorithm, there is no training set or ground truth establishment relevant to AI model training.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.