(153 days)
The IS4000 Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the IS4000 (da Vinci Xi) Surgical Systems and a compatible Ethicon Endo - Surgery Generator and Hand Piece.
The IS4000 8 mm Harmonic ACE Curved Shears is a single-use, sterile instrument used to deliver ultrasonic energy to enable transection and coagulation of tissue. The movement and function of the IS4000 8 mm Harmonic ACE Curved Shears are controlled by the surgeon from the Surgeon Console of the da Vinci Xi Surgical System (model IS4000). The instrument is compatible with the Ethicon Hand Piece (model HP054) and Ethicon Endo-Surgery Generator (model G11).
The provided text describes the IS4000 8mm Harmonic ACE™ Curved Shears, a surgical instrument intended for soft tissue incisions. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive clinical trials. Therefore, the information typically requested for AI/algorithm-based devices (such as sample sizes for test sets, expert qualifications for ground truth, MRMC studies, standalone performance, and training set details) is largely absent as it is not relevant to this type of device submission.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the performance tests and their results. The "acceptance criteria" are implied by the "Results" column, which consistently states "All final tests PASSED," indicating the device met its pre-defined requirements. Specific numerical acceptance criteria are not detailed in this summary.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Design Verification | Device meets dimensional, mechanical, functional, and electrical requirements/specs. | All final tests PASSED |
| Reliability (Life) | Instrument is robust in typical use environment (simulated clinical use, sterilization). | All final tests PASSED |
| Animal Testing | Device meets user needs and intended use as per Product Requirements. | All final tests PASSED |
| Human Factors/Usability | Safe and effective for intended users in intended use environment. | Usability is safe and effective (conclusion based on review and formative testing) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Design Verification: "Sample sizes up to six units were used."
- Reliability (Life Test): "A sample size of six was used."
- Animal Testing: The document states "simulated clinical models (animal)" were used, but the specific sample size for animal testing is not explicitly mentioned beyond the general statement for "Design Validation."
- Data Provenance: The tests are internal performance tests conducted by Intuitive Surgical, Inc. They are not clinical studies in a traditional sense with country of origin data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable or provided. The tests described are engineering performance tests (dimensional, mechanical, electrical, reliability cycling) and animal model evaluations, not diagnostic or AI-based analyses requiring expert consensus for ground truth. User needs and intended use in animal testing would be evaluated by relevant veterinary or surgical professionals involved in the study, but their specific number or qualifications are not stated.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or cases to establish ground truth in diagnostic studies. The tests here relied on pre-defined test procedures and objective pass/fail criteria, indicating a direct measurement/observation approach rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device in question is a surgical instrument, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a surgical instrument controlled by a surgeon (human-in-the-loop with the da Vinci Xi Surgical System). There is no standalone algorithm performance to evaluate.
7. The Type of Ground Truth Used:
The "ground truth" for the various tests are:
- Design Verification: Engineering specifications, dimensional tolerances, mechanical performance requirements, electrical safety standards, functional requirements.
- Reliability (Life): Expected lifespan characteristics, satisfactory visual inspection, functional integrity after simulated use.
- Animal Testing: "User needs and intended use as documented in the Product Requirements document." This implies the "ground truth" is adherence to predefined functional and performance characteristics in a physiological environment, confirmed by observations during animal surgery.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.