(239 days)
Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures.
Endoscopic Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The device includes Disposable Endoscopic Surgical Instrument and Reusable Endoscopic Surgical Instrument. Both of the disposable and reusable endoscopic instruments are provided sterile when they're released. After used for the first time, Reusable Endoscopic Instrument needs to be sterilized by the end users. The instruments are 5mm in diameter as well as 340mm in length.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics that would typically be found in an Acceptance Criteria table. Instead, it refers to compliance with international standards and internal design control procedures.
However, based on the non-clinical testing performed, we can infer some performance aspects:
| Feature/Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Testing in accordance with IEC 60601-1 (device passed) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Testing in accordance with IEC 60601-1-2 (device passed) |
| Special Requirements for Electrosurgical Units | Compliance with IEC 60601-2-2 | Testing in accordance with IEC 60601-2-2 (device passed) |
| Endoscopic Equipment (Electrosurgical) | Compliance with IEC 60601-2-18 | Testing in accordance with IEC 60601-2-18 (device passed) |
| Appearance | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Basic Dimension | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Corrosion Resistance | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Transverse Holding Force | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Longitudinal Holding Force | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Ratchet Holding Force | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Cutting Efficacy | Meets specification | All testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures. |
| Thermal Effects on Tissue | Acceptable thermal damage zone | The thermal effect has been performed on fresh pig's liver, kidney, and muscle tissue. The thermal damage zone is measured under magnification using histology after performing cauterizing. All testing results show the device meets internal specifications. |
| Biocompatibility | Compliance with ISO 10993 series | The device meets the applicable requirements of the FDA Blue Book Memorandum G95-11 entitled Use of International Standards ISO 10993-1:2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a risk management process, including ISO 10993-5, -7, -10, -11, -12. |
| Sterility (Reusable Instruments) | Sterility Assurance Level (SAL) of 10⁻⁶ | Both EO and Steam sterilization methods have been validated, and test reports show that the sterilization effect of the proposed device can achieve a SAL of 10⁻⁶. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes non-clinical laboratory testing (e.g., electrical safety, performance, biocompatibility). It does not involve a "test set" in the context of clinical data or AI model evaluation.
- Sample Size for performance tests: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with specified standards and characteristics. For the thermal effects on tissue, it involved "fresh pig's liver, kidney, and muscle tissue," but the number of samples is not quantified.
- Data Provenance: The tests were conducted in a laboratory setting as part of the device's design control and regulatory submission. The document doesn't specify the country of origin for the non-clinical test data itself, beyond the manufacturer being based in China. The study is a prospective evaluation of the device against predefined performance standards and characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is an electrosurgical instrument for cutting, dissecting, manipulating, and cauterizing tissues. There is no AI component or image analysis that would require expert adjudication to establish "ground truth" for a test set. The evaluation is based on objective measurements and compliance with technical standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of expert review or clinical data.
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
Not applicable. This is a medical device (surgical instrument), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manual surgical instrument that requires human operation. It does not have an autonomous algorithm component.
7. The Type of Ground Truth Used
The "ground truth" in this context is the objective, measurable performance of the physical device against established engineering standards and specifications. Examples include:
- Compliance with International Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 10993 series.
- Physical and Functional Specifications: Appearance, basic dimension, corrosion resistance, various holding forces (transverse, longitudinal, ratchet), cutting efficacy.
- Biological Outcome: Thermal damage zone measured via histology on tissue samples, sterility assurance level (SAL).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI model, there is no training set or associated ground truth establishment process.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.