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510(k) Data Aggregation
(175 days)
The HandX is intended to assist in the control of Human Xtensions 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 Self-Righting Needle Holder is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Self-Righting Needle Holder is connected to the HandX™ and transmits the motors' rotations to articulate the movement of the Self-Righting Needle Holder's end effector. Self-Righting Needle Holder orients the suturing needle vertically to 90° mounting. It is designed to address the surgeons' needs relating to suturing for various surgical purposes.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied from "predefined requirements") | Reported Device Performance |
|---|---|---|
| Self-Righting Needle Holder Angle Test | The subject device's articulation angles (when connected to HandX device) should be comparable to the predicate device. | "The subject device tip articulation ability is comparable to the predicate device." |
| SRNH instrument Dimensional Attribute | The subject device's dimensions must be within the specified requirements. | "The subject device dimensions are within the defined requirements." |
| SRNH Suture Holding Force | The subject device's suture holding force must withstand the defined requirements, comparable to the predicate device. | "The subject device suture holding force withstands the defined requirements as the predicate device." |
| SRNH Needle Pulling Moment | The subject device must maintain the needle in place under external moment, meeting the defined requirement. | "The subject device complies with the needle pulling moment requirement." |
| SRNH Needle Holding Force | The subject device must maintain the needle in place under external force, meeting the defined requirement. | "The subject device complies with the needle holder holding force requirement." |
| SRNH Needle Righting | The subject device must demonstrate the ability to transition a surgical needle to a "right position" (implicitly defined as 90° mounting, as mentioned in the device description). This implies functionality analogous to the reference device's self-righting capability. | "The subject device demonstrated transition ability of surgical needles to right position, thus met the predefined requirements." (The device description specifies "Self-Righting Needle Holder orients the suturing needle vertically to 90° mounting," which would be the specific "right position.") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific bench test. It mentions "The Self-Righting Needle Holder was subjected to bench testing," but does not provide details on the number of units tested.
- Data Provenance: The data is generated from bench testing conducted by the device manufacturer, Human Xtensions Ltd., to demonstrate that the design outputs meet the design input requirements. The country of origin of the testing is not explicitly stated, but the company is based in Israel. This is prospective testing for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This evaluation involves bench testing against predetermined engineering and performance specifications, not a clinical study requiring expert assessment of ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are objective bench tests, not assessments requiring adjudication.
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/imaging diagnostic device. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical instrument, not an algorithm. The device itself (the needle holder) performs the self-righting function, but its operation is "Electromechanically operated, software controlled" by the HandX™ device. The bench tests evaluate the performance of this physical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the bench tests is the "predefined acceptance criteria" derived from engineering specifications and comparisons to the predicate and reference devices. These criteria relate to physical properties and functional performance (e.g., specific angles, force thresholds, dimensional tolerances, and the ability to achieve a "right position").
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an algorithm that requires a training set. The "software controlled" aspect refers to the HandX™ device controlling the mechanical movement, not an AI/ML algorithm that is "trained."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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