(25 days)
The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester and polyethylene suture through soft tissue in endoscopic and other limited access procedures.
The Opus® SmartStitch™Suture Device with PerfectPasser is designed to allow the surgeon the option to place a simple stitch or a mattress stitch through soft tissue in endoscopic and other limited access procedures.
The provided document is a 510(k) summary for the Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study with detailed statistical analysis.
Therefore, many of the requested elements (like acceptance criteria, sample sizes for test sets, ground truth establishment methods, MRMC studies, or training set details) are not applicable or not provided in this type of regulatory document.
Here's the breakdown of what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: Not reported in terms of specific performance metrics or clinical outcomes. The document states that the "modification incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with PerfectPasser Connector" and "the device, as designed, is as safe and effective as the predicate device." This is the core "performance" claim for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. A formal "test set" in the context of an algorithm or statistical study proving performance is not detailed in this 510(k) submission. The submission is based on demonstrating equivalence, not on a new, comprehensive clinical performance study. There's no mention of specific data or its provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable / Not provided. As there's no defined "test set" and a requirement to establish ground truth for it, this information is not present.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
- No. This document does not describe an MRMC comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument (suture device), not an algorithm or AI. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- Not applicable / Not provided. The device is a physical surgical tool; the concept of "ground truth" as used for AI/algorithm validation doesn't apply directly here. The "proof" for substantial equivalence relies on comparing the device's design, materials, and intended use against a previously cleared device.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable / Not provided.
Summary of the Study (as described in the 510(k)):
The "study" presented in this 510(k) is a substantial equivalence comparison to a predicate device, rather than a de novo clinical trial or performance study.
- Predicate Device: Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector (K062244, Cleared 10/02/06).
- Nature of the "Study": The submission argues that the modified device is substantially equivalent because it "incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with PerfectPasser Connector."
- The "primary difference includes the addition of a material." The document asserts that this difference "does not raise any questions regarding the safety and effectiveness" and that "the materials are well characterized."
- Conclusion of the "Study": The device, as designed, is "as safe and effective as the predicate device."
This document primarily focuses on regulatory approval by demonstrating that a modified version of an already approved device remains safe and effective relative to its predicate, rather than providing detailed performance metrics from a new, extensive study.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.