(95 days)
The Intuitive Surgical 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
The 8mm SureForm 30 Staplers are fully wristed, articulating, surgical staplers which are designed for use exclusively with a compatible da Vinci Surgical System (herein referred to as "system"). The staplers are controlled by the surgeon using the Surgeon Console of the system. They are intended for resection, transection and/or creation of anastomoses in surgery and achieves its intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
The 8mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3Al2.5V) staples. The implantable staples are provided in various staple leg lengths (Gray, White, Blue) to accommodate various tissue types.
The provided document is a 510(k) summary for the Intuitive Surgical 8mm SureForm 30 Stapler and Reloads. It outlines the device description, indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria, specific reported device performance values, sample sizes for test sets, data provenance, expert details for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, training set sizes, or how training set ground truth was established for the device.
The document indicates that design verification, compatibility verification, transit verification, biocompatibility, design validation (simulated clinical use), and human factors testing were performed. It states, "The successful completion of testing demonstrated that the subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads design outputs continue to meet design inputs."
Since the detailed information you requested is not present in the provided text, I cannot complete the table or answer points 2-9. The document focuses on demonstrating substantial equivalence rather than providing a detailed technical report of specific performance metrics against acceptance criteria for a new AI/software device.
Here's a breakdown of what can be inferred or directly stated from the document, and where information is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties (critical dimensions, mass, materials, finish) | "Bench testing was performed to verify functional design outputs met the functional design inputs." "Successful completion of testing demonstrated that the subject...design outputs continue to meet design inputs." |
| Mechanical requirements (range of motion, friction, offset) | "Bench testing was performed to verify functional design outputs met the functional design inputs." "Successful completion of testing demonstrated that the subject...design outputs continue to meet design inputs." |
| Force limits | "Bench testing was performed to verify functional design outputs met the functional design inputs." "Successful completion of testing demonstrated that the subject...design outputs continue to meet design inputs." |
| Reliability | "Bench testing was performed to verify functional design outputs met the functional design inputs." "Successful completion of testing demonstrated that the subject...design outputs continue to meet design inputs." |
| Transit Performance (packaging integrity) | "Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems." |
| Biocompatibility | "Biocompatibility testing was completed in accordance with...ISO 10993-1:2018..." |
| User Needs/Intended Use (from simulated clinical use) | "Simulated clinical use testing was performed to validate that the product specifications continue to meet the user's needs and intended use." |
| Usability (related to use-related risks) | "A summative usability study was conducted to assess the use-related risks associated with the device user interface..." |
Missing Information for Table: The document doesn't provide specific numerical acceptance criteria (e.g., "staple height +/- 0.1mm") or quantitative performance results (e.g., "average staple height was X mm with a standard deviation of Y mm"). It only states that testing was "successful" and criteria were "met."
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: Not specified for any of the tests (design verification, transit, biocompatibility, design validation, human factors).
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 is not applicable as the document describes a surgical stapling device, not an AI/software device that requires expert-established ground truth on medical images or data. The "ground truth" for this type of device would be physical measurements and performance against engineering specifications. No experts are mentioned in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device submission. Adjudication methods are typically associated with expert review of medical data for AI/software evaluations.
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 applicable. This is a surgical stapling device, not an AI-assisted diagnostic or therapeutic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a surgical stapler, the "ground truth" would be established by engineering specifications, physical measurements (e.g., staple formation, cutting efficiency), and functional performance in simulated tissue models. The document refers to "functional design inputs" and "product specifications" rather than medical ground truth sources like pathology.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not a machine learning model.
In summary, the provided document is a 510(k) submission for a surgical stapler, which is a physical medical device. The detailed information requested in points 2-9 typically applies to AI/software as a medical device (SaMD) clearances or approvals, which involve data sets, ground truth establishment by experts, and performance evaluation of algorithms. The submission confirms that the device underwent standard physical device testing (mechanical, biocompatibility, usability) and met its design inputs, demonstrating substantial equivalence to its predicate.
§ 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.