(189 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 HandX™ Monopolar Spatula is a single-use sterile electrosurqical electrode for use with the HandX™ device. The Monopolar Spatula is connected to the HandX™ device and transmits the device motors' rotation to articulate the movement of the end effector of the Monopolar Spatula. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
The Monopolar Spatula is connected to a standard electrosurgical unit via a standard generator cable.
This document is a 510(k) summary for the HandX Monopolar Spatula, a medical device. It describes the device's intended use, comparison to a predicate device, and performance data.
Here's an analysis of the provided text in relation to acceptance criteria and study proving device meets those:
The provided text describes a 510(k) premarket notification for a medical device called the "HandX Monopolar Spatula". This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing acceptance criteria and conducting a study to prove the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning device.
The HandX Monopolar Spatula is an electrosurgical electrode, not an AI or machine learning device. Therefore, many of the typical criteria and study elements associated with AI device performance validation (like sensitivity, specificity, MRMC studies, ground truth establishment with experts, training set size, etc.) are not applicable to this submission.
The "acceptance criteria" for this device are primarily related to its physical, electrical, and biological performance, demonstrating it's as safe and effective as existing similar devices.
However, I will extract relevant information from the document that touches upon "acceptance criteria" and "studies" as best as possible, interpreting them within the context of a traditional medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the "acceptance criteria" are implied by successful completion of various tests, demonstrating compliance with standards and equivalence to the predicate. The "reported device performance" is the statement that these tests were passed successfully.
| Category / Test Type | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, demonstrating negligible risk of toxicity (cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity). | "The device was deemed to pose a negligible risk of toxicity and is considered to have met the requirements of ISO 10993-1:2018 and FDA's corresponding guidance and to be safe for use as intended." |
| Electrical Safety & EMC | Full compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6. | "The Monopolar Spatula was found to fully comply with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6." |
| Bench Testing | Design outputs meet design input requirements; device is safe and effective for intended use; all tests meet predefined acceptance criteria. | "All tests [Dimensional attributes, Seal Test, Tip Pull to Failure] met the predefined acceptance criteria, and testing identified no new questions of safety and effectiveness." |
| Thermal Effects Testing | Substantially equivalent thermal behavior compared to predicate and reference devices. | "The results supported the substantially equivalent thermal behavior of the Monopolar Spatula compared to the predicate and reference devices." (Based on ex-vivo and in-vivo studies using a porcine model to evaluate thermal behavior and lateral thermal spread). |
| Human Factors/Usability | Device can be used safely and effectively in accordance with its labeling. | "A summative evaluation study (per IEC 62366-1) confirmed that the device can be used safely and effectively in accordance with its labeling." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for most tests. For Thermal Effects Testing, it mentions a "porcine model," implying animal subjects, but no specific number of animals or trials. For Human Factors/Usability, a "summative evaluation study" was done, but the number of participants is not provided.
- Data Provenance: The document does not specify the country of origin for the data. The studies appear to be pre-market validation studies conducted by the manufacturer, rather than retrospective or prospective clinical data from a specific patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable in the context of an AI device. For this physical device, "ground truth" generally refers to design specifications, validated measurement techniques, and established safety standards. There is no mention of "experts" establishing a "ground truth" as would be done for diagnostic AI. The "Human Factors/Usability" study would likely involve trained medical professionals, but their role is to test usability, not establish a diagnostic ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no "ground truth" being established by multiple readers/experts in a diagnostic sense, no adjudication method (like 2+1, 3+1) is mentioned or relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/diagnostic device. An MRMC study is not relevant to demonstrating the safety and effectiveness of a surgical instrument of this type. The comparison is primarily against a predicate device based on physical, electrical, and biological performance characteristics, rather than diagnostic accuracy or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical surgical instrument that always requires a human in the loop for its operation. It does not contain an "algorithm" in the sense of an AI/machine learning component that could operate standalone.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance validation is derived from:
- Mechanical and Electrical Engineering Standards: Compliance with relevant IEC standards (e.g., IEC 60601 series).
- Biocompatibility Standards: Compliance with ISO 10993-1.
- Predefined Acceptance Criteria: Established internally by the manufacturer for bench tests (Dimensional attributes, Seal Test, Tip Pull to Failure).
- Comparative Performance: Demonstrating substantial equivalence in thermal behavior to a predicate and reference device in animal models.
- Usability Standards: Compliance with IEC 62366-1 for human factors/usability.
8. The Sample Size for the Training Set
- Not Applicable. This device does not use an AI/machine learning component, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no training set for an algorithm.
§ 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.