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510(k) Data Aggregation
(154 days)
SIRIUS Endoscope System (PR-SI-1230)
It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.
The SIRIUS Endoscope System as a robotic endoscope consists of Video Processor, Laparoscope Handle, Laparoscope Head and Joystick. The SIRIUS Endoscope System is developed for minimal invasive surgery application.
The SIRIUS Endoscope System is a fully integrated compact 3D laparoscopic camera system with a flexible tip that can change its viewing direction. The Laparoscope Head is made of biocompatible materials. The articulated tip has three degrees of freedom enabling C and S shaped bending. The insertion section is 10 mm diameter and 342 mm working length. Stereo camera with 1080 high-definition resolution. It has 90 degrees field of view, 10-100 mm depth of view.
The SIRIUS Endoscope System is to be used only under the supervision of a trained surgeon and professional clinical staff with trained use of the device.
The device is intended for use in Hospital operating theatres only.
This 510(k) clearance letter focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a specific study design typically seen for AI/ML devices or novel technologies. The "acceptance criteria" here are implicitly linked to the performance of the predicate device and relevant international standards.
Therefore, many of the specific details you requested regarding acceptance criteria and study design (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training sets) are not present in this type of document because the submission is not presenting evidence of novel diagnostic or assistive AI performance. It's a submission for a new model of an endoscope system, demonstrating it performs as safely and effectively as a previously cleared version.
However, I can extract information related to product performance and testing where available, and explain why other details are absent based on the nature of this 510(k) submission.
Analysis of Acceptance Criteria and Device Performance for SIRIUS Endoscope System (K250939)
The SIRIUS Endoscope System (PR-SI-1230) received 510(k) clearance based on its substantial equivalence to a predicate device (K221642: SIRIUS Endoscope System). The "acceptance criteria" in this context are not defined as specific performance metrics for a novel AI algorithm, but rather as meeting the safety, effectiveness, and performance standards expected of an endoscope system, particularly in comparison to its predicate. The studies provided focus on verifying that the new model performs comparably to the predicate and adheres to relevant industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for an updated hardware device (endoscope system) rather than a novel AI diagnostic, the acceptance criteria are primarily aligned with regulatory standards, predicate device performance, and international product standards. There are no specific AI performance metrics like sensitivity, specificity, or AUC mentioned.
| Category | Acceptance Criteria (Implied / Demonstrated by Compliance) | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility | Patient contacting components meet ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogen). | "The evaluation included the following tests: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogen", confirming compliance. |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶; EO and chlorohydrin residuals within limits per ISO 10993-7. | "Sterilization condition is validated per ISO 11135: 2014 overkill half-cycle approach. The sterility assurance level (SAL) is 10⁻⁶. The amount of ethylene oxide and chlorohydrin residual levels are within the limit and in compliance with ISO 10993-7." |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-18 standards for safety. | "The device complies with IEC 60601-1, IEC60601-2-18 standards for safety." |
| EMC | Compliance with IEC 60601-1-2 standard for EMC. | "The device complies with... the IEC 60601-1-2 standard for EMC." |
| Light Source Safety | Compliance with IEC 62471: 2006 (Risk Group 2). | "The lamp is certified as Risk group 2 and complies with IEC 62471: 2006." |
| Software V&V | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Basic Documentation Level). | "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance... The software documentation level applied for this device was considered as Basic Documentation." |
| Performance Testing | Compliance with specific ISO 8600 series standards for endoscopes (e.g., field of view, direction of view, width of insertion, water resistance). | Bench testing performed verifies compliance with: ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-7. |
| Usability | Acceptable residual risk regarding usability, benefits exceed possible risks of use-error, per ANSI/AAMI IEC 62366-1:2015+AMD1:2020. | "Formative and summative evaluations were conducted. Results and improvement action demonstrated that residual risk regarding usability is minimized and acceptable." |
| Technological Equivalence (Hardware Differences) | Performance equivalent for specified differences (e.g., working length, joystick design, locking mechanism). | Verified by electrical safety, EMC tests, and usability tests. Stated "no impact on the effectiveness and safety of the device." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of an AI/ML or diagnostic performance study. The "tests" mentioned are primarily bench tests, engineering validations, and usability evaluations, not clinical studies involving patient data or images. Therefore, details like data provenance or a specific test set sample size for diagnostic performance are not provided. The comparisons are against the predicate device's design and adherence to recognized performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is about the physical endoscope system, not an AI diagnostic algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the performance section refers to engineering specifications and compliance with international standards.
4. Adjudication Method for the Test Set
Not applicable, as there's no diagnostic test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not conducted or reported. This type of study is typically done for AI algorithms that assist or augment human reading of medical images to demonstrate improvement in reader performance. The SIRIUS Endoscope System is a hardware device for visualization and surgery, not an AI-powered diagnostic tool in that sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no standalone algorithm being evaluated for performance independent of human operation for diagnostic purposes. The "software" referred to in the document relates to the device's operational software, not an AI for image analysis.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterility, IEC 60601 series for electrical safety/EMC, IEC 62471 for light source safety, ISO 8600 series for endoscope performance, and ANSI/AAMI IEC 62366-1 for usability.
- Engineering Specifications: The design and function of the device itself are validated against its own specifications and those of the predicate.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is that the new device performs "as well as the legally marketed predicate device."
8. The Sample Size for the Training Set
Not applicable. This document does not describe 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 an AI/ML algorithm mentioned.
Summary of Study Type:
The submission focuses on design verification and validation testing to demonstrate that the new SIRIUS Endoscope System (PR-SI-1230) is safe, effective, and performs as well as its predicate. This includes ensuring compliance with a wide array of international standards (ISO, IEC, ANSI/AAMI) for medical device manufacturing, biocompatibility, electrical safety, sterility, and basic endoscope performance. The differences from the predicate (e.g., working length, joystick design, locking mechanism) were specifically verified through engineering and usability tests to ensure they did not negatively impact safety or effectiveness.
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