(344 days)
The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single-incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae (250 mm and 300 mm length), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm length), and a Single-Site Port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision. The da Vinci Single-Site Instruments and Accessories include instruments to perform grasping, cautery, cutting, clip ligation, suturing, and suction/irrigation functions. The instruments are non-wristed (similar to the predicate laparoscopic instruments). The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing IS3000 da Vinci Si Surgical System.
The provided document is a 510(k) summary for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories. This type of regulatory submission in the US is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance acceptance criteria via a comprehensive clinical study in the same way a PMA or a de novo submission might.
Therefore, the document does not contain the detailed information typically found in a study demonstrating how a device meets specific acceptance criteria with reported device performance against those criteria, sample sizes for test sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
However, I can extract information regarding the performance data mentioned and the type of studies conducted to support substantial equivalence.
Here's an attempt to answer your request based on the available information, noting where specific details are not provided:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Overview: The document states that "Bench, and cadaver testing demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements." Additionally, "an acute animal study was performed to validate the quality and effectiveness of closure of suture lines with the Single-Site Needle Driver and to establish substantial equivalence between the curved needle driver and the SILS Port and manual single incision instruments."
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of specific acceptance criteria or quantitative reported device performance metrics. Instead, it broadly states that "design output meets the design input requirements" and that the testing "demonstrate[s] that the subject device is substantially equivalent to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for the bench, cadaver, or animal studies.
- Data Provenance:
- Bench and Cadaver Testing: The document does not specify the country of origin. This testing is typically conducted in a laboratory setting.
- Acute Animal Study: The document does not specify the species or country of origin for the animal study.
- Retrospective or Prospective: These studies would typically be considered prospective for the purpose of generating data to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For an animal study involving surgical procedures, it is implied that qualified veterinary surgeons or equivalent personnel would be involved.
4. Adjudication Method for the Test Set
Not applicable/Not specified. The document does not describe a clinical study with an adjudication process for a test set. The validation in the animal study likely involved direct observation and measurement of surgical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Existence of Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is more common for imaging or diagnostic AI devices where human reader performance is being evaluated.
- Effect Size of Human Readers with/without AI Assistance: Not applicable, as no MRMC study was performed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Existence of Study: No, a standalone algorithm-only study was not conducted or described. The device is a surgical instrument system, which inherently requires human-in-the-loop operation.
7. Type of Ground Truth Used
- The document implies that "ground truth" was established through direct observation and measurement of outcomes in the bench, cadaver, and acute animal studies. For example, in the animal study, the "quality and effectiveness of closure of suture lines" would be the ground truth being assessed, likely through pathological examination or direct surgical assessment.
8. Sample Size for the Training Set
Not applicable. This device is a surgical instrument system, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML model is mentioned.
Summary of Device Performance Claims in the Document:
The performance data primarily aims to demonstrate substantial equivalence to predicate devices. The key statements are:
- "Bench, and cadaver testing demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements."
- "The differences do not raise any new issues of safety or effectiveness as compared to the predicate devices."
- An "acute animal study was performed to validate the quality and effectiveness of closure of suture lines with the Single-Site Needle Driver and to establish substantial equivalence between the curved needle driver and the SILS Port and manual single incision instruments."
§ 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.