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The HX Device is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.

The Human Extensions HX Device is a hand held powered laparoscopic device. The device enables, by its attached instruments grasper and needle holder, 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 HX Device is electromechanically controlled and includes both hardware and software and comprises of two major parts, the Handpiece and the Instrument. The HX Device Handpiece consists of a reusable Control Interface (CI) handle held by the surgeon and a Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip (grasper/needle holder). Prior to use, a set of single use, disposable, sterile Power Cable, Arc, Finger Pads, and strap-adapting Spacer are assembled on the Handpiece and the CI unit. In addition, prior to use, the Handpiece is covered with a standard, sterile cover (e.g., endoscopic camera cover) of at least 8.5 cm inner diameter. The sterile cover is not provided with the HX device. After each use, the Handpiece is cleaned and disinfected according to the specifications detailed in the Instructions For Use.

The provided text describes the regulatory clearance for the HX Device, a handheld powered laparoscopic device. It details the device's intended use, comparison to predicate devices, and the performance data submitted to support its substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All tests met the predefined acceptance criteria" for various bench tests and an animal study. However, the specific quantitative acceptance criteria values and the quantitative results of the device performance against these criteria are not explicitly stated in the provided text.

The text broadly lists the types of tests conducted and states their successful completion:

2. Sample Size Used for the Test Set and Data Provenance

• Bench Testing: The text does not specify the exact sample sizes (number of devices, instruments, or tests) used for the various bench tests. It only states that these tests were conducted.
• Animal Study: The text does not specify the sample size (number of animals or procedures) used for the GLP animal study.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a regulatory submission for a new device, it's highly probable that the studies were prospective and conducted to generate data for this submission. The manufacturer, Human Extensions Ltd., is based in Israel, so the studies were likely conducted there or in a region that supports GLP standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Bench Testing: Not applicable in the context of "ground truth" established by experts in the same way as clinical imagery interpretation. These tests evaluate quantifiable physical properties and performance.
• Animal Study: The text states, "GLP Animal Study was performed by several users." It then mentions, "Users were able to perform tissue manipulation tasks such as grasping different tissues, and to perform continues or interrupted sutures tasks." These "users" are implicitly the experts who performed the procedures and evaluated the device's performance, but their specific number or qualifications (e.g., "veterinarian with X years of experience," or "surgeon with Y years of experience") are not detailed.

4. Adjudication Method for the Test Set

• Bench Testing: Adjudication is not typically relevant here, as results are usually objective measurements against defined specifications.
• Animal Study: The text mentions that the study was performed by "several users" and that the "devices performed well without malfunction to users' satisfaction." This suggests a subjective assessment by the users, but no formal adjudication method (like 2+1 or 3+1 consensus) is described among these users.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study is mentioned or implied. The document focuses on demonstrating the device's basic performance, reliability, and safety attributes, and showing substantial equivalence to predicate devices, rather than a comparative effectiveness study involving human readers' diagnostic accuracy or changes in their performance with AI assistance. The HX Device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• This concept is not directly applicable. The HX Device is a physical, electromechanically controlled surgical instrument that is always "human-in-the-loop," as it is "controlled by the surgeon's hand." While it has software, its performance is intrinsically tied to human operation. The software validation mentioned is for the functionality of the device's embedded software, not for a standalone diagnostic algorithm.

7. Type of Ground Truth Used

• Bench Testing: Ground truth is established by the definitions of the physical and mechanical properties being measured and the predefined acceptance criteria for those measurements.
• Animal Study: The ground truth for the animal study appears to be defined by the successful completion of specified surgical tasks (tissue manipulation, grasping, suturing) without device malfunction, and the "satisfaction" of the users (operators). This is an observational and performance-based ground truth within a controlled preclinical setting. It does not rely on pathology or outcomes data in the sense of long-term patient follow-up, but rather on immediate operational success and device reliability during simulated procedures.

8. Sample Size for the Training Set

• The document addresses a regulatory submission for device performance and equivalence, not an AI model's training. Therefore, there is no mention of a "training set" in the context of machine learning. The device's design and engineering are based on principles of mechanical and electrical engineering, validated through the described tests.

9. How the Ground Truth for the Training Set Was Established

• As there is no training set for an AI model mentioned, this question is not applicable.

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