(212 days)
The Intuitive Surgical Stapler SureForm 60 reloads, and other stapler accessories are intended to be used with a compatible da Vinci Systems for resection, transection, 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 60 and SureForm 60 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 60 is a disposable, fully wristed articulating device. The SureForm 60 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The reloads are available in four configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel). Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses.
The provided text describes the performance data for the Intuitive Surgical SureForm 60 and SureForm 60 Reloads, which are surgical staplers. The studies described are primarily animal validation studies, bench testing, and human factors evaluation, aiming to demonstrate substantial equivalence to predicate devices rather than proving a novel AI algorithm's performance. Therefore, many of the requested categories related to AI performance metrics, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable or not present in the provided document.
However, I can extract the relevant information regarding acceptance criteria and study outcomes for the device's performance, focusing on the animal validation studies as they contain explicit "study outcomes" which can be interpreted as demonstrating the device meets the underlying acceptance criteria for safety and effectiveness.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a single table for all tests. Instead, the "Study Outcome" column in Table 2 (and the Venous Burst Pressure study) acts as the fulfillment of implied acceptance criteria by confirming successful operation, equivalence to predicate devices, and lack of adverse events. I will synthesize these based on the study outcomes.
| Study Name | Implied Acceptance Criteria (Based on Study Outcome) | Reported Device Performance |
|---|---|---|
| Animal Survival Study: Lobectomy | - No intra-operative leaks |
- 28-day survival
- No bleeding/leakage at staple lines post-survival period
- Well-healed staple lines | All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both subject and predicate devices. |
| Animal Survival Study: Lung Wedge Resection | - No intra-operative leaks - 7-day survival
- No bleeding/leakage at staple lines post-survival period
- Well-healed staple lines | All staple lines passed assessment for leaks intra-operatively. All animals survived through the 7-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both test and control devices. |
| Animal Survival Study: Gastrectomy – canine | - No intra-operative leaks - 14-day survival
- No bleeding/leakage at staple lines post-survival period
- Well-healed staple lines | All subject staple lines passed intra-operative leak tests. All animals survived through the 14-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both subject and predicate devices (1 predicate staple line needed oversewing for leak test). |
| Animal Survival Study: Gastrectomy – porcine | - No intra-operative leaks - 14-day survival
- No bleeding/leakage at staple lines post-survival period
- Well-healed staple lines | All staple lines passed intra-operative leak tests. All animals survived through the 14-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both subject and predicate devices. |
| Animal Survival Study: Small bowel anastomosis | - Passed visual assessment intra-operatively - No involvement of anastomosis sites in cause of death if early death occurs
- Normal tissue healing at anastomosis sites | All staple lines passed visual assessment intra-operatively. Early death of one animal due to peritonitis, not involving anastomosis sites (confirmed by histopathology). Another animal expired due to strangulation of small intestine (containing predicate anastomosis site) through a mesenteric defect; predicate anastomosis site uninvolved with cause of death, exhibited normal tissue healing. Staple lines in remaining animals passed leak testing after 14-day survival period. No active bleeding or leakage. Staple lines well-healed. |
| Staple Line Performance | - Met all acceptance criteria for transection, tissue layer approximation, hemostasis, and staple formation - Wrist angle has no effect on staple formation quality | 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 | - Well-formed staples in-vivo - Clinically acceptable tissue approximation, transection, and hemostasis
- Not adversely affected by buttress materials when used as instructed | 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 | - Met all acceptance criteria - Similar or superior tissue effects (tissue approximation and hemostasis) compared to predicate
- Met staple formation acceptance criteria (no more than three sub-optimal staples within each test fire) | The subject device met all acceptance criteria, exhibiting similar or superior tissue effects (tissue approximation and hemostasis) when compared to the adjacent Echelon Flex 60 Powered Plus 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 | - Met all acceptance criteria | The subject device met all acceptance criteria. |
| Burst Pressure (General) | - Substantially equivalent to predicate device with no statistically significant difference in staple line burst pressures | The staple lines from the subject device performed substantially equivalent to that of the predicate device as there was no statistically significant difference in staple line burst pressures. |
| Venous Burst Pressure | - All jugular vein seals passed 45mmHg for 10 seconds pressure acceptance criteria - Demonstrated non-inferiority to predicate device | All jugular vein seals that were burst pressure tested passed the 45mmHg for 10 seconds pressure acceptance criteria with both the subject and predicate devices. The subject device demonstrated non-inferiority to the Echelon Flex 60 Powered Plus. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the animals used in the validation studies. There is no AI test set explicitly mentioned.
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Animal Studies Sample Sizes:
- Lobectomy: 8 Canine
- Lung Wedge Resection: 8 Canine
- Gastrectomy (canine): 8 Canine
- Gastrectomy (porcine): 8 Porcine
- Small bowel anastomosis: 8 Porcine
- Nephrectomy: 8 Porcine
- Staple Line Performance: 4 Canine and 7 Porcine
- Buttress Material Compatibility: 1 Canine, 1 Porcine
- Maximum Torque: 2 Porcine
- Design Validation: 2 Porcine
- Burst Pressure (General): 1 animal (Excised tissue and in-vivo model)
- Venous Burst Pressure: Excised Porcine Jugular Veins (number not specified, but likely multiple samples from these veins)
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Data Provenance: The studies are described as "animal validation studies" performed using "simulated clinical models (animal)" and "clinical laboratory setting closely approximating an intraoperative use situation." The data is thus prospective animal study data. Country of origin is not specified but is presumably where Intuitive Surgical operates or contracts its animal labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number or qualifications of experts establishing ground truth. The "Study Outcome" is implicitly determined by the researchers conducting the animal studies and evaluating the results (e.g., assessing leaks, healing, staple formation).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the animal study outcomes. The outcomes are presented as direct observations and assessments by the study team.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for evaluating diagnostic or interpretive AI systems in a clinical reading setting with human readers, which is not what this premarket notification describes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a surgical stapler, not an AI algorithm. The performance studies evaluate the physical device's function, not an AI algorithm's standalone performance.
7. Type of Ground Truth Used
The ground truth used here is primarily direct observation of physiological outcomes in animal models, including:
- Intra-operative leak tests
- Survival rates
- Visual assessment of bleeding, leakage, and healing at staple lines during terminal procedures
- Histopathology (for cause of death in specific cases)
- Assessment of transection, tissue layer approximation, hemostasis, and staple formation
- Burst pressure measurements
Essentially, it's physiological and pathological ground truth established through direct experimental observation and measurement.
8. Sample Size for the Training Set
Not applicable. There is no AI model or algorithm that would require a "training set" described in this document.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI model or training set, this question is not relevant to the provided text.
§ 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.