(30 days)
The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.
The RealHand Instruments are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissor blades) are activated by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place, a rotation control wheel and articulation lock.
The provided text describes a 510(k) submission for the RealHand™ High Dexterity (HD) Instruments. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through the rigorous study designs typically associated with AI/ML devices. As such, many of the requested categories are not applicable or cannot be extracted from this document in the context of an "AI/ML device."
Here's an analysis based on the provided text, highlighting where information is available and where it's not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated as AC for AI/ML) | Reported Device Performance |
|---|---|
| Conformance to product specification (General) | "Testing included grasping, manipulating, cutting and suturing of tissue." "The results showed the RealHand Instruments were equivalent to the predicate device." |
| Equivalence to predicate device (Specifically for K043541) | "The RealHand Instruments are equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Testing comparing the RealHand Instruments to a commercially available predicate product was conducted." but does not quantify the number of instruments tested or the number of procedures performed.
- Data Provenance: Not specified. The study involved "tissue," which could be ex-vivo, in-vivo animal, or human (though less likely for equivalence studies of this nature without explicit mention). The country of origin is not mentioned. The study appears to be prospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical instrument, not an AI/ML diagnostic or predictive tool requiring expert-established ground truth for its performance evaluation in the way an AI algorithm would. Its performance was assessed through functional testing and comparison to a predicate, not clinical accuracy or diagnostic interpretation.
4. Adjudication method for the test set:
- Not applicable. As above, this is for a surgical instrument, not an AI/ML device requiring adjudication of diagnostic outputs.
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 not an AI/ML device, and no MRMC study was performed as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional testing, the "ground truth" was likely defined by the successful execution of intended actions (grasping, manipulating, cutting, suturing tissue) as per the product specifications and comparison to the predicate device's performance. There's no mention of expert consensus, pathology, or outcomes data being used to establish ground truth in the context of an AI/ML performance metric.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, and therefore no training set was used.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, no ground truth was established for this purpose.
Summary of the Device Evaluation Approach in this Document:
The evaluation of the RealHand™ High Dexterity (HD) Instruments for its 510(k) clearance was based on demonstrating substantial equivalence to an existing legally marketed predicate device (Endolink TM True Movement System™ K043541). This involved:
- Bench Testing: "Product testing was conducted to evaluate conformance to product specification. Testing included grasping, manipulating, cutting and suturing of tissue."
- Comparative Testing: "Testing comparing the RealHand Instruments to a commercially available predicate product was conducted. The products were used per their respective Instructions for Use. The results showed the RealHand Instruments were equivalent to the predicate device."
- Review of intended use, basic overall function, methods of manufacturing, and materials used.
The clearance states that "The RealHand Instruments are equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent." This meets the regulatory requirements for a 510(k) submission, confirming it is as safe and effective as the predicate device.
§ 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.