(21 days)
The RealHand™ High Dexterity (HD) instruments are intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.
A new electroconductive pathway was added. This change consists of two basic modifications to the existing instruments: 1) a post was added to attach a third party generator via an insulated commercially available legally marketed cable. 2) an internal jumper was added to conduct current from the post to the internal shaft of the instrument. The substantial equivalence of the changes are based on a comparison of physical and functional attributes of the device contrasted with the Novare predicate and the indications of the Pajunk instruments.
The place of manufacture has not changed. The physical appearance of the device, though slightly different, does not adversely affect the modified device. Functional expectations, material suitability, surgical technique and indications for use are just the same as the comparison devices placed in product code GCI by FDA.
RealHand™ High Dexterity Instruments are substantially equivalent to the original instruments with respect to functionality and performance characteristics based the following criteria:
-
RealHand™ High Dexterity Instruments provide hemostatic clamping that allows electrocautery and ligature of tissue. The performance of the systems are essentially identical.
-
The RealHand™ High Dexterity Instruments were carefully evaluated and compared with the original Novare device. Documented testing established that the characteristics are equal to the original.
-
The original device was evaluated for proper function during use. The modified RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent, and
-
the RealHand™ High Dexterity Instruments worked as intended.
The provided text is a 510(k) summary for the RealHand High Dexterity (HD) Instruments. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval).
Therefore, the information you've requested regarding acceptance criteria, specific study details with sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this document.
The document outlines the rationale for substantial equivalence based on physical and functional attributes. It does not contain data from a study designed to meet specific performance acceptance criteria in the way you've described.
Here's a breakdown of what is available in the document, framed against your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable in the traditional sense. The document asserts substantial equivalence, not performance against specific, quantifiable acceptance criteria.
- What is present:
The document states:- "RealHand™ High Dexterity Instruments provide hemostatic clamping that allows electrocautery and ligature of tissue. The performance of the systems are essentially identical." (to the predicate device)
- "Documented testing established that the characteristics are equal to the original." (predicate device)
- "The modified RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent..." (to the predicate device)
- "...the RealHand™ High Dexterity Instruments worked as intended."
2. Sample Size for Test Set and Data Provenance
- Not Provided. The document mentions "documented testing," but does not specify sample sizes for these tests, the type of data, or its provenance (e.g., country of origin, retrospective/prospective clinical data).
3. Number of Experts and Qualifications for Ground Truth
- Not Provided. This information is relevant for studies establishing ground truth, which is not described in this 510(k) summary.
4. Adjudication Method
- Not Provided. Not applicable given the nature of the submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Performed/Reported. There is no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. This device is a surgical instrument, not an imaging or diagnostic AI-powered tool.
6. Standalone Algorithm Performance
- Not Performed/Reported. This device is a physical surgical instrument, not an algorithm or AI.
7. Type of Ground Truth Used
- Not Applicable in the context of this 510(k). "Ground truth" typically refers to definitive diagnostic or outcome data for evaluating an algorithm's accuracy. Here, the comparison is to the functional attributes of a predicate device. The "ground truth" implicitly refers to the established safety and performance of the predicate device.
8. Sample Size for the Training Set
- Not Applicable. As this is a physical device submission, there is no "training set" in the sense of machine learning algorithms.
9. How Ground Truth for Training Set was Established
- Not Applicable. Same as above.
In summary: The provided document is a 510(k) premarket notification for a modified surgical instrument. It aims to demonstrate "substantial equivalence" to existing legally marketed devices, primarily by comparing physical and functional characteristics. It does not contain the kind of detailed study data, acceptance criteria, sample sizes, or ground truth methodologies that would be present in a submission for an AI/ML-powered diagnostic device or a de novo classification requiring new performance data.
§ 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.