(59 days)
The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical SureForm 45 and SureForm 45 Reloads is a disposable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SureForm 45 Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. As described in Table 1, the reloads are available in four configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).
The information provided describes the SureForm 45 and SureForm 45 Reloads surgical stapler system. The study focuses on demonstrating substantial equivalence to a predicate device, the SureForm 60, through various performance tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text describes the outcomes of the studies rather than explicit numerical acceptance criteria. However, the outcomes confirm that the device met these implicit criteria.
| Study Name | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Staple Line Performance | Acceptable transection, tissue layer approximation, hemostasis, and staple formation; no effect of wrist angle. | The subject device met all acceptance criteria and exhibited acceptable pass rates in the areas of transection, tissue layer approximation, hemostasis, and staple formation. Wrist angle also had no effect on the quality of staple formation. |
| Buttress Material Compatibility | Clinically acceptable tissue approximation, transection, hemostasis, and optimal staple formation when buttress material is used. | Pass rates in the areas of transection, tissue layer approximation, hemostasis, and optimal staple formation were not adversely affected in a statistically significant manner when buttress material was used in accordance with the manufacturer's Instructions for Use. |
| Maximum Torque | Similar tissue effects (approximation and hemostasis) compared to predicate; optimal staple formation (no more than three suboptimal staples per test fire). | The subject device met all acceptance criteria, exhibiting similar tissue effects (tissue approximation and hemostasis) when compared to the adjacent SureForm 60 staple lines. The subject device also met the staple formation acceptance criteria with no more than three sub-optimal staples within each test fire. |
| Design Validation | Meet all design input requirements and user needs/intended uses in a clinical laboratory setting. | The subject device met all acceptance criteria. |
| Burst Pressure | Substantial equivalence or non-inferiority to the predicate device. | The staple lines from the subject device performed substantially equivalent to that of the predicate device. The subject device demonstrated non-inferiority to the predicate SureForm 60 and SureForm 60 Reloads. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Sizes:
- Staple Line Performance: 4 Canine, 4 Porcine
- Buttress Material Compatibility: 4 Canine, 4 Porcine
- Maximum Torque: 2 Canine, 2 Porcine
- Design Validation: 3 Porcine
- Burst Pressure: Excised jugular venous and stomach tissue from Porcine (specific number of samples not quantified)
- Data Provenance: The studies were prospective acute in-vivo animal model studies using canine and porcine subjects. The country of origin is not specified but is implicitly assumed to be the location where Intuitive Surgical, Inc. conducts its preclinical research.
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)
The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal studies. The evaluation appears to be based on direct observation of outcomes (e.g., transection, hemostasis, staple formation) and measurements (e.g., burst pressure) rather than subjective expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method as would be typical for studies involving human ratings or interpretations. The evaluations appear to be direct assessments of the surgical outcomes in the animal models.
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 MRMC comparative effectiveness study was performed or mentioned. The device is a surgical stapler system, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The SureForm 45 is a surgical stapler system, a mechanical device for use with a da Vinci Surgical System, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth was established through direct physiological and physical outcomes data observed in acute in-vivo animal models, including:
- Visual assessment of transection, tissue layer approximation, and hemostasis.
- Evaluation of staple formation (e.g., number of suboptimal staples).
- Quantitative measurements such as burst pressure.
8. The sample size for the training set
This question is not applicable. The SureForm 45 is a mechanical surgical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "training" in this context refers to design and engineering work, not data-driven model learning.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
§ 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.