(324 days)
The ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue.
The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by use of high frequency electric current.
Manually operated surgical instruments are available with or without monopolar high frequency connection and are designed to be used through an opening maintained by a cannula which allows inserting and removal of the instrument(s) without damaging the tissue(s).
Bipolar Forceps are designed to grasp, manipulate and coagulate selected soft tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator.
Suction/ Irrigation Cannulas have an application(s) in laparoscopic procedures such as gynecologic, general, thoracic and urology and are intended to provide suction and irrigation to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Trocars and Trocar Sleeves are intended to create portals into an operative site for the direct visualization and/or inserting of other surgical instruments.
Needle holders are intended to grasp and manipulate needles inside the peritoneal cavity enabling a surgeon to suture internal soft tissue during a laparoscopic procedure.
Instruments should be used only by personnel completely familiar with their operation.
These devices represent a family of Laparoscopic/Endoscopic Instruments and Accessories that consist of:
- . Laparoscopic Monopolar electrodes
- . Laparoscopic Bipolar forceps
- Laparoscopic Trocars, Trocar sleeves
- . Laparoscopic Needle Holders
- . Laparoscopic Suction/ Irrigation Cannulas
- . Laparoscopic Suture and Ligature Instruments
- . Laparoscopic various manually operated surgical instruments with and without monopolar high frequency connection ( scissors, graspers/dissectors, biopsy forceps)
- . Laparoscopic Accessories such as: Cleaning Brushes, Sealing Caps, Adapters
Various configurations, sizes and handles of the jaws (graspers, forceps, scissors, dissectors, biopsy, and punches) exist to meet the needs of surgical procedures in conjunction with a laparoscope/endoscope. The instruments have the capability for monopolar RF current, if needed. These instruments are composed of biocompatible materials (surgical grade stainless steel, PTFE, PEEK, several coatings, silicon and brass chromium plated). These materials have a long history of biocompatibility for human use at short term contact. The instruments are reusable and sold non-sterile.
This document is an FDA 510(k) clearance letter and summary for ELMED Laparoscopic Instruments and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's diagnostic performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria and study design for AI/diagnostic algorithms is not present in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) because it is a clearance for surgical instruments, not a diagnostic AI algorithm. The clearance is based on substantial equivalence for safety and effectiveness, demonstrated through non-clinical testing.
The document states:
- "The results also demonstrate that ELMED Laparoscopic Instruments and Accessories are as safe and effective as the predicate device."
- "ELMED Laparoscopic Instruments and Accessories are as safe and effective as the predicate device."
The types of non-clinical testing performed are listed, which act as the "acceptance criteria" for these surgical instruments:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | Conforms to "Mechanical Stress Testing" requirements |
| Conforms to "Mechanical Push/Pull Testing" requirements | |
| Conforms to "Drop Testing" requirements | |
| Electrical Safety Testing | Conforms to "Dielectric Strength Testing" |
| Conforms to "Capacitive Coupling Testing" | |
| Conforms to "Leakage Current Testing" | |
| Electromagnetic Testing | Conforms to "Electromagnetic Interference/Immunity Testing" |
| Biocompatibility | Instruments composed of "biocompatible materials (surgical grade stainless steel, PTFE, PEEK, several coatings, silicon and brass chromium plated)" with "a long history of biocompatibility for human use at short term contact." |
| International Standards | Conforms to IEC 60601-2-2 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes the clearance of surgical instruments, not a device relying on a test set of data for performance evaluation. The "testing" refers to physical and electrical evaluations of the instruments themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth assessment by experts in the context of data for diagnostic performance is not relevant to the clearance of these surgical instruments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. 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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For these surgical instruments, the "ground truth" for demonstrating safety and effectiveness relies on established engineering and medical device standards (e.g., IEC 60601-2-2) and the inherent properties of the materials and design, demonstrating that the device performs its intended mechanical and electrical functions safely. There isn't a "ground truth" in the diagnostic data sense.
8. The sample size for the training set
Not applicable. There is no training set as this is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.