(60 days)
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.
The da Vinci SP Firefly Imaging System is a fully integrated, adjunct imaging system for the da Vinci SP Surgical System. The da Vinci SP Surgical System is a robotic-assisted surgical device (RASD) that is designed to enable complex surgery using a minimally invasive approach. The system consists of three major subsystems: the Surgeon Console, the Vision Cart, and the Patient Cart.
The da Vinci SP Firefly Imaging System consists of the following components of the da Vinci SP Surgical System (refer to Figure 1):
o the Endoscope Controller (light source) on the Vision Cart
o the SP Endoscope, 0° (subject device), which is installed on the Patient Cart
The Endoscope Controller provides a light source, either visible light or a near-infrared (NIR) excitation laser.
The Endoscope transmits visible light or NIR light from the Endoscope Controller via optical fibers to illuminate the surgical site. The stereoscopic camera at the Endoscope tip images the surgical site in either visible light mode or fluorescence imaging mode.
The provided FDA clearance letter for the SP Endoscope, 0° (430600) does not contain detailed information about the acceptance criteria and study results in the format requested. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing comprehensive efficacy study results.
Specifically, the document states that "The successful completion of testing demonstrated that the subject device (SP Endoscope, PN 430600) design outputs meet the design inputs, and the design validation validated that the user needs are met." However, it does not provide specific quantitative acceptance criteria or detailed performance data against those criteria.
Therefore, many of the requested fields cannot be accurately populated from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided definitively. The document lists various tests performed (Design Verification, Reliability Testing, Cleaning Validation, Transit Verification, Biocompatibility, Design Validation, EMC Testing) and states that the device "successfully met the acceptance criteria" or "met all acceptance criteria." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not detailed. For example, for "Range of Motion" verification, the specific range of motion deemed acceptable and the actual measured range are not present.
2. Sample size used for the test set and the data provenance:
- Cannot be provided definitively. The document mentions "a series of tests" and "bench testing" but does not specify the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Cannot be provided. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies that require expert readings to establish ground truth). The tests described here are primarily engineering and performance verification tests for a physical endoscope, not studies requiring expert clinical judgment for ground truth establishment. Even for "Simulated clinical use testing," details about expert involvement for ground truth are absent.
4. Adjudication method for the test set:
- Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved to establish a robust ground truth. The tests mentioned here do not fit this context.
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 such study was described. The device is an endoscope and imaging system, not an AI-powered diagnostic tool intended to assist human readers in a comparative effectiveness study. The document focuses on the device's physical and functional performance, not its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an endoscope, a physical instrument for visualization, not a standalone algorithm.
7. The type of ground truth used:
- Implicit: Engineering specifications and regulatory standards. For the various tests, the "ground truth" implicitly refers to the predefined engineering design inputs, performance specifications, and requirements outlined in relevant standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1-2 for EMC, AAMI standards for cleaning). The document states that the device "met the acceptance criteria" for these standards and specifications.
8. The sample size for the training set:
- Not applicable. This device is a physical endoscope, not an AI model that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is involved for this type of device.
Summary of available information regarding acceptance criteria and studies:
The document broadly outlines the types of studies performed as evidence for substantial equivalence, focusing on design and safety aspects:
-
Design Verification:
- Focus Areas: Design Properties, Range of Motion, PSC Interaction, Optical Performance, Electrical Properties, Firefly, Mechanical requirements (Crimp Strength, Window Strength, Extended Illumination, Tip Durability, and Manifold Air Permeability).
- Acceptance Criteria: "Functional design outputs met the functional design inputs." (Specific criteria not detailed in the provided text).
- Outcome: "Bench testing was performed to verify that the functional design outputs met the functional design inputs."
-
Reliability Testing:
- Focus: Impact of increased number of lives (uses) and reprocessing cycles (50 lives, 60 reprocessing cycles for subject device vs. 33 lives, 40 cycles for predicate).
- Acceptance Criteria: That the device "is not adversely affected by the increased number of lives (uses) and reprocessing cycles." (Specific criteria not detailed).
- Outcome: "Reliability Testing was performed to ensure that...the subject device...is not adversely affected..." (Implies successful outcome).
-
Cleaning Validation:
- Focus: Efficacy of the manual cleaning process.
- Acceptance Criteria: Compliance with FDA Guidance, AAMI ST98:2022, AAMI TIR 12:2020, AAMI TIR 30: 2011/(R)2016, ISO 17664-1:2022. "Successfully met the acceptance criteria for all markers."
- Outcome: "demonstrate that the subject device can be cleaned using the manual cleaning process."
-
Transit Verification Testing:
- Focus: Performance during shipping and distribution.
- Acceptance Criteria: Compliance with ASTM D4169-22. "Met all the acceptance criteria."
- Outcome: "demonstrate that the subject device has been validated for use within the shipping and distribution environment."
-
Biocompatibility:
- Focus: Biological safety of patient-contacting materials.
- Acceptance Criteria: Compliance with FDA Guidance: Use of International Standard ISO-10993 and ISO 10993-1:2018. "Met all acceptance criteria for biocompatibility testing."
- Outcome: "Biological Safety Assessment...determined that there was negligible risk to patient safety under its intended use."
-
Design Validation:
- Focus: Product specifications meeting user's needs and intended use.
- Acceptance Criteria: Implicitly, that "the product specifications meet the user's needs and intended use." (Specific details not provided).
- Outcome: "Simulated clinical use testing was performed to validate that the product specifications meet the user's needs and intended use."
-
EMC Testing:
- Focus: Electromagnetic compatibility.
- Acceptance Criteria: Compliance with IEC 60601-1-2 Edition 4.1 2020-09.
- Outcome: "The test results demonstrate that the subject device meets the applicable requirements within this standard."
In conclusion, the provided text confirms that specific validation and verification activities were conducted to demonstrate the safety and effectiveness of the SP Endoscope, 0°. However, it does not offer the granular detail of quantitative acceptance criteria and reported performance values typically requested for a comprehensive study breakdown. This is common for 510(k) summaries where the primary goal is to establish substantial equivalence based on a comparison to a predicate device and adherence to recognized standards.
§ 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.