(251 days)
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
The Medigus SRS is an Endoscopic Surgical Stapling System. The system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.
The endoscopic stapler is a single use, sterile device which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil.
The distal tip is retroflexed to align with the staple cartridge located in the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application.
The control console includes the insufflation, light and camera electronics.
The associated accessories include:
- . Irrigation bottle with liquids for irrigation of the camera lens
- Silicon tubes for connecting the console and other accessories to the stapler .
- . Standard overtube for protecting patient's pharynx
- Tweezers to remove and replace staple cartridge .
- . Staple cartridges
Differences between the predicate device and subject device are summarized as follows:
- The subject device has a single console whereas the predicate had two consoles.
- The subject device has an improved user interface and software controls . compared to the predicate.
- . The subject device uses an electric motor to power staple ejection, whereas the predicate device manually ejected staples.
- . The subject device contains an alignment pin mechanism to allow accurate alignment of the stapling anvil and cartridge.
- The subject devices uses an LED for illumination, whereas the predicate . contained a Xenon lamp.
- . The subject device contains a CMOS camera, whereas the predicate contained a CCD camera.
The provided text describes a medical device, the Medigus SRS Endoscopic Stapling System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in a clinical or AI-related context.
The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a previously cleared device. This type of submission typically relies on non-clinical performance data (e.g., biocompatibility, electrical safety, mechanical testing) and comparison of technical characteristics to the predicate, rather than a clinical trial with acceptance criteria for device performance against ground truth.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an analysis of the provided information in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Not found. The document does not specify quantitative clinical acceptance criteria or report device performance against such metrics. It lists non-clinical performance data categories that were submitted (Biocompatibility, Electrical safety, Software validation, Sterilization validation, Mechanical and acoustic testing, LED photobiological and thermal safety testing, Camera/optics characterization testing) but does not provide specific criteria or results for these.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not found. This information would typically come from a clinical trial or a specific performance study, which is not detailed in this 510(k) summary. The listed performance data are non-clinical.
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 found. Ground truth establishment by experts is relevant for clinical or diagnostic AI studies. This document concerns a surgical stapling system for which this type of ground truth is not applicable in the context of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not found. N/A, as no expert-adjudicated test set is described.
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 found. N/A, as this device is a surgical tool, not an AI-assisted diagnostic or interpretation system that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not found. N/A, as this is a surgical device, not an AI algorithm. Its "standalone" performance would refer to its mechanical and functional operation, which is covered by the non-clinical tests mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not found. N/A. For a surgical device, "ground truth" often relates to successful surgical outcomes or objective measurements from mechanical tests. The document implies that the device's function was verified through mechanical and other non-clinical tests rather than by comparison to clinical ground truth derived from patient outcomes or pathology in a study specific to this submission.
8. The sample size for the training set
- Not found. N/A, as this is not an AI/ML device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not found. N/A, as this is not an AI/ML device.
Summary regarding the provided text:
The document describes the Medigus SRS Endoscopic Stapling System and focuses on demonstrating its substantial equivalence to an existing predicate device (K120299 Medigus SRS Endoscopic Stapling System) for a 510(k) clearance.
- Intended Use/Indications for Use: The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach to create an anterior partial fundoplication for treating symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
- Differences from Predicate Device: The document highlights several technical differences in the subject device, such as a single console, improved user interface, electric motor for staple ejection (vs. manual), an alignment pin mechanism, LED illumination (vs. Xenon lamp), and a CMOS camera (vs. CCD camera).
- Performance Data (Non-clinical): The substantial equivalence determination was supported by non-clinical performance data, including:
- Biocompatibility testing
- Electrical safety and electromagnetic compatibility
- Software validation
- Sterilization validation
- Mechanical and acoustic testing
- LED photobiological and thermal safety testing
- Camera/optics characterization testing
- Conclusion: The device has the same intended use and indications, and similar principles of operation and technological characteristics as the predicate. The minor differences do not raise new questions of safety or effectiveness, and the performance data supports its equivalence.
In conclusion, this 510(k) summary demonstrates that the Medigus SRS Endoscopic Stapling System is substantially equivalent to its predicate based on non-clinical performance and technological comparison, rather than a clinical study with specific acceptance criteria as you've outlined for AI or diagnostic devices.
§ 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.