(41 days)
The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.
The da Vinci Xi Hasson Cone is a cone-shaped device which is intended to be used in endoscopic surgery to anchor a port of entry (i.e., cannula) to the patient. During Hasson, or open, surgical techniques, the user places a Hasson Cone in the opening of the body wall. The cannula shaft is inserted into the cone, effectively increasing the diameter of the cannula to the contour of the incision made in the body wall.
The Hasson Cone will be offered in two sizes; 8 mm and 12 mm & Stapler.
The provided document is a 510(k) premarket notification for the Intuitive Surgical da Vinci Xi Hasson Cone. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets specific performance criteria in the format requested.
The document states that "Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." It lists the types of testing conducted but does not provide specific numerical acceptance criteria or the reported device performance against those criteria.
Therefore, I cannot populate the table or provide detailed answers to many of the questions as the information is not present in the provided text. I will indicate where the information is not available.
Description of the Acceptance Criteria and Study:
The document broadly states that performance data (bench and animal testing) demonstrated that the da Vinci Xi Hasson Cone is substantially equivalent to a predicate device and that its design output meets design input requirements. The testing included:
- Dimensional measurements
- Mechanical and functional verification
- Simulated use in animal models
- Human factors assessment
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| Specific criteria not provided in document | Specific performance data not provided in document |
| Bench Testing Categories: | |
| Physical Specifications | Demonstrated to meet input requirements |
| Mechanical Requirements | Demonstrated to meet input requirements |
| User Interface Requirements | Demonstrated to meet input requirements |
| Functional Requirements | Demonstrated to meet input requirements |
| Animal Validation Categories: | |
| General Requirements | Validated |
| Functional Requirements | Validated |
| Use and Misuse-Related Requirements | Validated |
| Interaction (Compatibility) Requirements | Validated |
| Human Factors Evaluation: | |
| All risks assessed as "Tolerable" or "Broadly Acceptable" | All risks assessed as "Tolerable" or "Broadly Acceptable" pre-mitigated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in the document. The document mentions "animal and cadaveric models" for design validation testing but does not provide quantities.
- Data provenance: Not specified. Testing was described as "bench" and "animal and cadaveric models," suggesting prospective
testing, but detailed provenance (e.g., country of origin) is not mentioned.
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/Not specified. The context of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus on images) does not directly apply to the mechanical and functional device testing described. The "experts" would likely be the engineers and perhaps surgeons involved in the animal validation, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This is typically relevant for studies involving human interpretation of data where consensus is needed to establish ground truth. For device performance testing, the "adjudication" would be based on meeting predefined engineering specifications and functional outcomes.
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
- No. The document describes a medical device (Hasson cone) used in laparoscopic surgery, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device testing is adherence to engineering specifications, functional performance in simulated environments (bench testing), and successful operation within animal/cadaveric models. It's based on objective measurements and observed physical outcomes rather than expert interpretation of diagnostic data or pathology.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI model.
§ 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.