(60 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 Human Xtensions HandX is a handheld powered laparoscopic device. The HandX enables, by its attached instruments Grasper, Needle Holder and Monopolar Hook, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension," enhancing maneuverability and control.
The HandX device is electromechanically controlled and includes both hardware and software. The device is comprised of two main parts: the Handpiece and the Instrument. The Handpiece consists of a reusable Control Interface (CI) handle and Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip. The tip moves according to the CI's direction. Prior to use, a set of Power Cable, Finger Pads, Arc and Spacer are assembled on the Handpiece and the Handpiece is covered with a standard sterile cover (not provided with the HandX device). After use, the Instrument is disposed of, and the Handpiece is cleaned and disinfected per specifications in the Instructions for Use.
Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for Human Xtensions Ltd.'s HandX device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. Therefore, the "study" demonstrating the device meets acceptance criteria primarily revolves around usability testing for a new operating mode and showing that this modification does not introduce new safety or effectiveness concerns. There is no large-scale clinical trial data presented to assess diagnostic accuracy or treatment efficacy as might be seen for AI-driven diagnostic tools.
1. Table of Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" here relate to the safety and effectiveness of the new "inverted control mode" and ensuring that the modified device (HandX) remains substantially equivalent to its predicates (HX Device and Monopolar Hook).
| Acceptance Criteria (Implicit from 510(k) context) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Safety: The addition of the inverted control mode does not introduce new or unacceptable safety risks. | "The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users." |
| Effectiveness: The device, with the new control mode, remains effective for its intended use. | The document states this difference ("inverted control mode") "does not raise new questions of safety or effectiveness, as it does not alter the fundamental therapeutic purpose of the device or its basic principles of operation (users control the inserted instruments in the same manner, just using one or another set of vectors)." It also notes, "The new mode also does not change the key metrics for evaluating device safety and performance, and is supported by successful usability testing." The implication is that since usability was successful, and the fundamental principle of operation remains, effectiveness is maintained. No specific quantitative effectiveness metrics are provided beyond this qualitative statement based on usability. |
| Usability: The inverted control mode is usable and understandable by target users. | "The company conducted usability testing of the inverted control mode in line with IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, as well as FDA's 2016 guidance document. The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users." |
| Substantial Equivalence: The HandX (with new mode) is substantially equivalent to predicate devices. | The overall conclusion of the 510(k) is: "Based on the intended use, technological characteristics, principles of operation, and usability testing, it can be concluded that the HandX is substantially equivalent to its predicate devices." The detailed comparison table in Section 5 shows the similarities and only identifies the addition of the "inverted control mode" as a notable difference, which they argue does not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size (number of participants) for the usability testing. It mentions "both novel and experienced users," implying a mix of experience levels, but no specific count.
- Data Provenance: The document does not explicitly state the country of origin for the usability testing data. However, the submitter is "Human Xtensions Ltd., Netanya, Israel," suggesting the testing could have been conducted in Israel or elsewhere (e.g., US, given the US legal representation). It was prospective usability testing conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For this type of 510(k) (device modification based on usability), the concept of "ground truth" as it applies to diagnostic image analysis (e.g., presence/absence of disease) is not directly applicable.
- Instead, the "ground truth" is established by adherence to usability standards and the ability of users to successfully and safely operate the device. The "experts" involved would implicitly be human factors engineers, clinical experts (surgeons) participating in the usability study, and potentially regulatory experts reviewing the study design and results.
- The document does not specify the number or qualifications of these implicit "experts" beyond mentioning "novel and experienced users" in the usability study.
4. Adjudication Method for the Test Set
- Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple readers interpret medical images to resolve discrepancies.
- This is a usability study for a surgical instrument's control mode. The "adjudication" would involve human factors engineers observing user performance, collecting user feedback, and analyzing quantitative (e.g., task completion time, errors) and qualitative (e.g., subjective ratings, comments) data against pre-defined success criteria for usability and safety.
- The document does not describe a specific adjudication method in the sense of reconciling differing expert opinions on a "ground truth" diagnosis. Usability assessment is a different paradigm.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done.
- This type of study is common for AI-driven diagnostic tools to show improvement in human reader performance.
- The HandX device is a surgical instrument with a modified control mode, not an AI diagnostic tool.
- The study described is a usability study for the new control mode, not a comparative effectiveness study pitting human readers with vs. without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable.
- The HandX is a physical surgical instrument with electromechanical and software components, designed for human operation. It is not an "algorithm" in the sense of an AI model that operates in a standalone capacity (e.g., analyzing images without human input).
- Its "performance" is inherently human-in-the-loop, as it's a tool controlled by a surgeon.
7. The Type of Ground Truth Used
- For the usability study, the "ground truth" is based on usability standards and successful task completion/safe operation.
- This is established by adherence to standards like IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, and the observation that "potential safety-critical consequences are reasonably mitigated" and instructional materials were "clear and easy to understand."
- It is not clinical "outcomes data" or "pathology" in the traditional sense for a diagnostic device.
8. The Sample Size for the Training Set
- Not applicable / No training set described.
- This device is not an AI/ML algorithm that requires a "training set" of data in the manner that a deep learning model would.
- The software aspect discussed pertains to the control interface logic ("direct control" vs. "inverted control"), which is programmed, not "trained" on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no described training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The device's functionality is based on engineering design and programming, verified through testing (including usability).
§ 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.