(100 days)
The SP Advanced Access Port Kit is intended to be used in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port.
The subject da Vinci SP Advanced Access Port Kit, Large Incision is a sterile, single-use, disposable accessory to the da Vinci SP Surgical System, Model SP1098, the predicate device is the cleared da Vinci SP Access Port Kit 510(k) #K202571). It provides surgical access for the SP1098 system during minimally invasive robotic surgery. The da Vinci SP Advanced Access Port Kit is compatible with the existing EndoWrist SP Instruments, SP Endoscope, and manual laparoscopic instruments (referred to as "assist instruments") and other compatible laparoscopic devices through a single incision while maintaining insufflation, which is identical to the predicate device. It is also compatible with Intuitive da Vinci SP 12mm Instruments, unlike the predicate device. The subject device enables superficial instrument articulation, like the predicate device.
The provided text is a 510(k) summary for the "da Vinci SP Advanced Access Port Kit (432701)". It describes the device, its intended use, a comparison to a predicate device, and performance data. However, it does not explicitly state "acceptance criteria" in a quantitative table or detail a specific study with statistical results to "prove the device meets the acceptance criteria" in the way one might expect for a new diagnostic or AI-driven device.
Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (da Vinci SP Access Port Kit, K202571). The "performance data" section primarily describes the types of testing performed to verify that the design meets requirements, rather than presenting a statistical acceptance criteria table with corresponding performance metrics.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent or implicitly addressed:
1. Table of Acceptance Criteria and Reported Device Performance
Observation: The document does not provide a table of explicit, quantitative acceptance criteria with corresponding performance metrics in the format typically seen for a new AI/diagnostic device. The submission focuses on demonstrating substantial equivalence through various tests. The "acceptance criteria" are implied to be the successful demonstration that the device's design output meets its design input requirements and that it functions comparably to the predicate device.
| Acceptance Criteria (Implied / Type of Test) | Reported Device Performance / Outcome (Qualitative) |
|---|---|
| Physical specifications met | Testing performed, design meets requirements |
| Mechanical requirements met | Testing performed, design meets requirements |
| User Interface and Patient Safety met | Testing performed, design meets requirements |
| Reliability met | Testing performed, design meets requirements |
| Environmental requirements met | Testing performed, design meets requirements |
| Shelf-life and Sterilization met | Testing performed, design meets requirements |
| Shipping and Storage met | Testing performed, design meets requirements |
| Package and Labeling met | Testing performed, design meets requirements |
| Clinical performance (anatomical access/reach) | Demonstrated in cadaver models |
| Safety and performance (live tissue) | Assessed in live animal models |
| Biocompatibility | All patient-contacting materials are biocompatible per ISO 10993-1 |
| Human Factors (Use-related issues, comparative task analysis, risk analysis, formative usability) | Activities conducted, risks documented, design informed, assessment confirmed |
2. Sample size used for the test set and the data provenance
Test Set Sample Size: Not specified in terms of numerical size for bench, cadaver, or animal testing. For human factors, the activities are described but no specific "test set" sample size for users is given.
Data Provenance:
- Bench tests: Likely internal to Intuitive Surgical, Inc.
- Cadaver models: Origin not specified, but typically from human anatomy labs.
- Animal models: Origin not specified, but live animal studies are typically conducted under controlled laboratory conditions.
- Human Factors: Post-market data and MAUDE database (for known use-related issues of predicate devices). Formative usability evaluations were conducted during development, suggesting prospective data collection from users.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Observation: This type of information is not applicable to this submission, as the device is a surgical access port kit, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device relates to its physical performance, safety, and functional equivalence to a predicate, which are assessed through engineering tests, anatomical studies, and physiological assessments rather than expert consensus on diagnostic images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Observation: This concept of "adjudication method" is not applicable here because the device is hardware (an access port kit) and the studies are primarily engineering verification, animal, and cadaver studies, not clinical trials requiring adjudication of outcomes by multiple experts.
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
Observation: This type of study is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic imaging devices (where "readers" are typically radiologists or clinicians interpreting images). The "da Vinci SP Advanced Access Port Kit" is a surgical accessory and not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Observation: This concept is not applicable to this device. The device is a surgical port kit, not an algorithm. Its function inherently involves human interaction (surgeons using it with a robotic system).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Observation: As noted in point 3, the concept of "ground truth" in the diagnostic sense is not applicable. The "ground truth" for this device's performance is established by:
- Engineering specifications and standards: For physical, mechanical, reliability, environmental, shelf-life, sterilization, shipping, storage, packaging, and labeling tests.
- Anatomical and physiological assessment: For cadaver and animal studies, confirming appropriate access, reach, tissue handling, and hemostasis.
- Biocompatibility standards: ISO 10993-1 for patient-contacting materials.
- Predicate device performance: The primary "ground truth" or benchmark for substantial equivalence is the previously cleared da Vinci SP Access Port Kit (K202571).
8. The sample size for the training set
Observation: This information is not applicable. As a physical medical device (an access port kit), there is no "training set" in the context of machine learning or artificial intelligence.
9. How the ground truth for the training set was established
Observation: This information is not applicable as there is no training set for this 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.