(84 days)
This product has applications for surgery in the saphenous vein, or radial artery for establishment of a port of entry for endoscopic instruments.
The Short Port Blunt Tip Trocar (BTT) is used to provide a port of access for insertion of endoscopic instruments into an incision site. The device consists of a main body with a Balloon on the distal end, a Balloon inflation port, an Endoscope seal on the proximal end, and an external port with a one-way valve for gas insufflation. It also includes a Cannula seal to allow insertion of the Harvesting Cannula. The balloon minimizes leakage and secures the port. A 30 cc syringe is provided for inflation/deflation of the Balloon.
The provided text details a 510(k) premarket notification for a medical device, the MAQUET Cardiovascular Short Port Blunt Tip Trocar (BTT), rather than an AI/ML software device. Therefore, the information requested for AI/ML device acceptance criteria and study particulars is not present in the document.
The document discusses the substantial equivalence of the Short Port BTT to predicate devices based on:
- Intended Use: Same
- Operating Principles: Same
- Sterilization: Same materials and processes
- Packaging: Same
Differences noted:
- Material change from Latex balloon (implying the new device does not use Latex, though not explicitly stated as such, it's inferred from the "Revision of Latex content statement").
- Labeling change regarding Latex content.
- Change from "converter door" to "Cannula Seal and 7mm O Seal."
The document states that these differences are "not considered a technological difference and is substantially equivalent to the predicate devices."
The "study" mentioned is the development process and testing conducted to demonstrate substantial equivalence, not an AI/ML specific study. The results of these in-vitro tests are cited as demonstrating that "the functionality and performance characteristics of the device are comparable to the currently marketed Short Port BTT."
Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria and studies, as this document pertains to a traditional medical device (trocar) and not an AI/ML product.
However, I can extract information relevant to a traditional medical device submission based on the provided text:
Acceptance Criteria and Reported Device Performance (Traditional Medical Device Context):
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Same intended use | Yes, same intended use. |
| Same operating principles | Yes, same operating principles. |
| Same sterilization methods and materials | Yes, sterilized using the same materials and processes. |
| Same packaging | Yes, has same packaging. |
| Functionality comparable to predicate | Functionality and performance characteristics proven comparable through in-vitro tests. |
Missing Information (for AI/ML context, not applicable here):
- Sample size for the test set and data provenance: Not applicable. The "test set" here refers to in-vitro performance tests of the physical device.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable. The ground truth here is the performance of the predicate device for comparison in physical tests.
- Sample size for the training set: Not applicable.
- 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.