(76 days)
The HandX™ is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX™ monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use
The Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Monopolar Scissors is connected to the HandX and transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
The provided text describes the HandXTM Monopolar Scissors, a single-use, disposable, ETO sterilized instrument. The device is intended to assist in the control of Human Xtensions laparoscopic instruments for endoscopic manipulation of tissue in various surgical procedures involving grasping, approximation, ligation, suturing, cutting, and/or coagulation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document broadly states that "All tests met the predefined acceptance criteria" for various bench tests. However, it does not explicitly list specific numerical acceptance criteria or quantitative performance results for each test. Instead, it confirms that the device passed these tests.
| Test Category | Specific Tests | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity | Not explicitly defined, but based on ISO 10993-1:2018, ISO 14971:2019, and FDA guidance documents, the materials should not cause unacceptable biological reactions or risks when in limited (≤24 hours) contact with tissue or bone. | "Based upon the biological risk assessment and the results of biocompatibility testing performed on the device, it can be concluded that the device can be considered biocompatible for use as intended." |
| Electrical Safety and EMC | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6. | The device must meet the electrical safety and electromagnetic compatibility requirements of the specified IEC standards to ensure safe operation and prevent interference with other equipment. | "The Monopolar Scissors was found to fully comply with the requirements of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6." |
| Bench Testing | Instrument Dimensional Attribute, Articulation Angle and Roll Range Measurement, Roll and Grasp Torque Measurement Method, Instrument Articulation latency, Impedance Test, Dielectric Strength, Insulation Integrity test, Generator Cable Compatibility with Extension Cables, Proximal Seal Test, Tip Integrity, Deflection Integrity, Cutting Integrity, Performance Test (instrument integrity following simulated use), Human Factors Summative Evaluation, Human Factors Labeling Validation, Instrument Corrosion Test | Predefined acceptance criteria for each test to demonstrate that design outputs meet design input requirements and that the device is safe and effective for its intended use. These would typically include specific ranges or thresholds for dimensions, angles, torques, electrical properties, structural integrity after use, and user interaction. | "All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness." |
| Performance Testing - Animal (Swine Model) | Safety (thermal damage evaluation using temperature probes and histopathology evaluation) and functional performance and usability comparison with a reference device. | For safety, thermal damage and histopathology results should be acceptable and comparable to the reference device. For performance and usability, the device should function effectively and be usable by qualified personnel, as assessed by questionnaires. | "It can be concluded that the Monopolar Scissors instrument passed all the per-defined acceptance criteria for safety, performance and usability." "Temperature and histopathology evaluations were performed following slits formation on porcine tissue... as compared to the reference device ENDOPATH® Scissors... in various working modes... and in different energy levels." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The sample size for each specific bench test is not provided. The data provenance is implied to be from internal laboratory testing.
- Performance Testing - Animal (Swine Model): The number of animals used is not specified. The study involved qualified personnel performing tasks with both the subject and reference device. This appears to be a prospective study conducted in a controlled environment (animal lab). The country of origin for the data is not explicitly mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Bench Testing: The document does not mention the use of external experts to establish ground truth for bench tests. These tests are typically evaluated against engineering specifications and validated test methods.
- Performance Testing - Animal: "Qualified personnel with appropriate experience" executed the evaluation and filled out questionnaires. The specific number or detailed qualifications (e.g., years of experience, specialty) of these personnel are not provided. For thermal damage and histopathology, it is implied that experts (e.g., a pathologist) evaluated the tissue, but their number and specific qualifications are not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for reconciling varying opinions, as no multiple expert readings of the test results are mentioned. For bench tests, it's typically a direct comparison to predefined criteria. For the animal study, it appears to be based on observations, measurements, and questionnaires by the "qualified personnel."
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, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers interpreting results. The animal study did compare the device to a reference device, but this was a functional comparison, not an assessment of human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this question doesn't apply directly to the HandXTM Monopolar Scissors. It is a physical surgical instrument, not an algorithm. Its performance is always with a human-in-the-loop (the surgeon).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-1, ISO 14971) and FDA guidance, with testing for specific biological endpoints (cytotoxicity, sensitization, etc.).
- Electrical Safety and EMC: Ground truth was established by compliance with international electrical safety and EMC standards (IEC 60601 series).
- Bench Testing: Ground truth was based on engineering design input requirements and validated test methods, with established predefined acceptance criteria.
- Performance Testing - Animal: Ground truth for safety was assessed by "thermal damage evaluation using temperature probes and histopathology evaluation according to FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff." For functional performance and usability, it was through direct observation during surgical tasks and post-procedure questionnaires completed by "qualified personnel." This combines objective measurements (temperature, histopathology) with subjective assessment (usability questionnaires).
8. The sample size for the training set
The concept of a "training set" is not applicable here as the device is a physical surgical instrument, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.