(51 days)
The Medigus Ultrasonic Surgical Endostapler (MUSE™) 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 Ultrasonic Surgical Endostapler (MUSE™) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed 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 (EtO) 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 shaft of 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 (EtO) 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
The provided text describes a 510(k) premarket notification for the Medigus Ultrasonic Surgical Endostapler (MUSE™) System. The document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new diagnostic or AI-driven device.
Based on the information provided, here's an analysis:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes for the MUSE system itself. Instead, it relies on comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate | Dimensional comparisons conducted: (Details not provided, but deemed acceptable for equivalence.) |
| Mechanical Testing conducted: (Details not provided, but deemed acceptable for equivalence.) | |
| Biocompatibility Testing conducted: (Details not provided, but deemed acceptable for equivalence.) | |
| The modified device's overtube does not raise new safety or effectiveness concerns. | Performance data demonstrates comparable performance to the predicate device. |
The "acceptance criteria" here are fundamentally about demonstrating that the modified device (which has a different overtube) is as safe and effective as the predicate device (which is K143634 Medigus SRS Endoscopic Stapling System (Trade Name MUSE)).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific "test set" sample sizes, data provenance, or study types (retrospective/prospective) in the context of comprehensive clinical or performance studies for the MUSE system's effectiveness. The "performance data" mentioned (dimensional, mechanical, biocompatibility) are likely engineering tests and not clinical studies with patient sample sizes.
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)
This information is not applicable to the type of submission described. The submission focuses on substantial equivalence based on engineering and bench testing, not on interpreting data where expert consensus would establish ground truth (e.g., for diagnostic imaging).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the type of submission 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
An MRMC study is not mentioned because this device (an endoscopic stapler) is a surgical tool, not an AI-assisted diagnostic or interpretation system that would involve "human readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The MUSE system is an operative device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in diagnostic or AI studies is not directly applicable here. For the engineering tests mentioned (dimensional, mechanical, biocompatibility), the ground truth would be established by validated test methods, reference standards, and laboratory measurements. For substantial equivalence, the "ground truth" is that the predicate device is already legally marketed and presumed safe and effective.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable. There is no mention of a "training set."
Summary of what the document focuses on:
The provided document is an FDA 510(k) clearance letter for a modified medical device. The "study" described is a demonstration of substantial equivalence to a previously cleared predicate device (K143634 Medigus SRS Endoscopic Stapling System).
The primary evidence given to support substantial equivalence are:
- Dimensional comparisons: Showing that the modified device's measurements are consistent with the predicate.
- Mechanical Testing: Demonstrating that the modified device's functional and structural integrity match the predicate.
- Biocompatibility Testing: Ensuring that the materials of the modified device are safe for human contact, likely conforming to ISO standards.
The key point is that the only difference between the predicate and the subject device is the manufacturer of the overtube. The FDA concluded that these minor differences do not raise any new or different questions of safety or effectiveness, and that the performance data demonstrates comparable performance to the predicate. Therefore, the acceptance criteria are met by proving the new device is essentially the same, with no negative impact on safety or efficacy, as the already-approved predicate device.
§ 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.