(9 days)
The THD N-Ano Anoscopes, are intended for physician use to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.
The disposable, not sterile THD N-ano anoscope is a disposable, not sterile anoscope with an integrated LED light source. The device is designed for the examination o the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures. The light source is integrated on the handle. Differently than predicate devices (Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope - K103647) disposable, not sterile THD N-ano Anoscope does not have any accessory and is available only "not sterile"
The provided text describes a 510(k) summary for the THD N-ANO ANOSCOPE, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in a clinical or diagnostic setting. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in the provided text.
The document highlights modifications made to the THD N-ANO ANOSCOPE compared to its predicate device (THD S.p.A. Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope, K103647). The review process involves design control activities, risk analysis, and a declaration of conformity, aiming to ensure that the modifications do not adversely affect the safety and performance of the device.
Here's a breakdown of the information that can be extracted or deduced from your input:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. Instead, the "acceptance criteria" are implied to be substantial equivalence to the predicate device, meaning the modified device performs as safely and effectively as the original device.
The reported "performance" relates to the design and materials of the device, rather than diagnostic metrics.
| Acceptance Criteria (Implied) | Reported Device "Performance" (Design Changes) |
|---|---|
| Safety and Performance Equivalence to Predicate Device (K103647) | - Handle modified to lodge LED light source circuit components (LED circuit itself unchanged). |
- LED light source block eliminated (due to handle modification).
- Cover of LED light source circuit made of ABS Terluran (vs. ABS Lustran in predicate).
- Dimensions are "not more critical than dimensions of predicate devices" (Length: 105mm vs. 90mm/130mm, Diameter: 21.7mm vs. 22.1mm/26.1mm/15.1mm).
- White polypropylene tip on introducer eliminated. |
| Intended Use Equivalence | The THD N-Ano Anoscope is indicated for the same intended use: "to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures." |
| Materials Equivalence | Manufactured with the same materials and the same process as the predicate family of devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a test set or clinical study to evaluate diagnostic performance. The evaluation is focused on engineering and design changes and their impact on substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth for a test set is established in this document as it's not a clinical performance study.
4. Adjudication Method for the Test Set
Not applicable. No test set or expert adjudication is described for clinical performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention any MRMC study or an assessment of human reader improvement with or without AI assistance. This device is a physical instrument, not an AI or diagnostic software.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an algorithm or AI-driven device, so a standalone performance study in that context is not relevant.
7. Type of Ground Truth Used
Not applicable in the context of diagnostic performance. The "ground truth" here is the predicate device and its established safety and efficacy, to which the modified device is compared through design and material analysis.
8. Sample Size for the Training Set
Not applicable. No training set is mentioned as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Document's Focus:
This 510(k) summary is for a medical device (anoscope) where the manufacturer is seeking FDA clearance based on substantial equivalence to a previously cleared predicate device. The changes described are primarily related to mechanical design (handle, LED light source integration, dimensions) and material of a component. The "study" referenced implicitly is the design control process, risk analysis, and material compatibility assessment to demonstrate that these modifications do not alter the fundamental safety or effectiveness of the device compared to the predicate. It is not a clinical trial evaluating diagnostic accuracy or a performance study of AI.
§ 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.