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The Surgical Image Laboratories Laparoscope is equivalent in materials, intended use, safety and effectiveness to the Dyonics 8000 Laparoscope. The outer tube is fabricated from 304 stainless steel. The block and light adapter are made from plated brass and the I.D. ring from anodized aluminum. The distal end tip is fabricated from optical glass which may be coated with an anti-reflective coating. The optic tube which fits within the outer tube is fabricated from stainless steel. The distal fiber which transmits light from the light source through the fiber cone, around the optic tube, and on to the surgical area is fabricated from optical fibers and sealed at the distal end with adhesive. The eye shield or camera connection adapter is made from acetal plastic or an FDA accepted equivalent. All surfaces are smooth and polished or bead blasted. The end of the instrument that is inserted into the human body through an incision is blunt or rounded with no sharp edges.
The provided text describes a 510(k) summary for the Surgical Image Laboratories Laparoscope, asserting its equivalence to existing laparoscopes, specifically mentioning the Dyonics 8000 Laparoscope. This document focuses on material composition, intended use, safety, and effectiveness. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined for an AI-powered diagnostic device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text is for a traditional medical device (a laparoscope), outlining its physical properties and claiming substantial equivalence to other devices on the market based on its design, materials, and intended use, rather than a performance study with specific acceptance criteria as would be typical for a diagnostic AI.
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Image /page/0/Picture/0 description: The image shows a logo with a circular graphic on the left and text on the right. The graphic contains the letters 'STI' in a stylized font, enclosed within a circle with horizontal lines. To the right of the graphic, the text reads 'SURGI' on the top line and 'LABOR' on the bottom line, both in a bold, sans-serif font.
<955845
6 West Newport Center Dr. · Deerlield Beach, FL 33442 · (800) 917-2673 · Tel: (305) 480-8323 · Fax: (305) 480-8376
510(k) SUMMARY
"This summary of 510(k) safely and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92"
The Surgical Image Laboratories Laparoscope is equivalent in materials, intended use, safety and effectiveness to the Dyonics 8000 Laparoscope
The outer tube of the Surgical Image Laparoscope are fabricated from 304 stainless steel. This stainless steel, often referred to as "Surgical Steel" has been used in various medical and surgical procedures for many years, including existing laparoscopes, as was chosen for the Surgical Image Laparoscope because it is non-reactive with the human body, is easy to clean and sterilize, and poses no danger to the patients as long as it is prepared for use appropriately and used by a qualified professional trained technician.
The block and light adapter are made from plated brass and the I.D. ring from anodized aluminum.
As with laparoscopes existing before Surgical Image's Laparoscope, the distal end tip of the laparoscope that is inserted into the body through a small incision during surgery is fabricated from optical glass which may be coated with an anti-reflective coating to reduce or eliminate glare during the surgical procedure. The glass and the coating applied thereto also are non-reactive with the human body and pose no danger to the patient.
As with laparoscopes existing before Surgical Image's Laparoscope, the optic tube which fits within the outer tube is fabricated from stainless steel. Although this tube is covered at the tip by the distal window and therefore does not come into contact with internal body organs, it is still fabricated from a material that is non-reactive with human tissue and which poses no danger to the patient.
As with laparoscopes existing before Surgical Image's Laparoscopes, the distal fiber which transmits light from the light source through the fiber cone, around the optic tube, and on to the surgical area is fabricated from optical fibers and sealed at the distal end with adhesive. Nevertheless, these materials are again non-reactive with human tissue and pose no danger to the patient.
As with laparoscopes existing before Surgical Image's Laparoscopes, the eve shield or camera connection adapter is made from acetal plastic or an FDA accepted equivalent.
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As with laparoscopes existing before Surgical Image's Laparoscopes, all surfaces of the Surgical Image's Laparoscope are smooth and polished or bead blasted to provide a cosmetically accepted surface. The end of the instrument that is inserted into the human body through an incision is blunt or rounded with no sharp edges.
The Surgical Image's Laparoscope is a totally benign instrument that in and of itself does not and cannot put a patient at any risk of injury when it is used for its intended purpose by properly trained and qualified personnel.
The Surgical Image's Laparoscope is substantially equivalent to laparoscopes that are manufactured by such companies as Olympus Corporation, Richard Wolf Medical Instruments Corporation, Karl Storz Endoscopy, Smith & Nephew Dyonics, and Stryker Endoscopes, and which have now been in the marketplace in the United States and throughout the world for many vears.
§ 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.