(199 days)
Dilation of the anal sphincter and canal for the relief of hemorrhoidal pain and itching, reduction of bleeding, and promotion of healing of inflamed hemorrhoidal tissues.
The Anokryo Dilator consists of a narrow tapered shaft approximately 2.75 inch long and 0.5 inch wide. The hollow interior of the shaft is filled with hydroxyethylcellulose solution before the shaft is molded to a flange knob which serves as a handle The shaft and flange are composed of polyethylene. The device is supplied clean and non-sterile in a plastic storage container and a water-soluble lubricant gel. Prior to use, the rod is stored in its container for 1-2 hours and then moistened with the lubricant gel. A maximum low temperature of -15 degrees C is obtained and sustained for 10 minutes. The device is easily cleaned with detergent and water and stored in its container for reuse.
This document is a 510(k) premarket notification for a rectal dilator device named Anokryo. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full clinical study with acceptance criteria and performance data in the way a novel, higher-risk device might.
Therefore, many of the requested details about acceptance criteria, specific study design elements, and performance metrics are not available in the provided text. The submission relies on the established safety and effectiveness of its predicate devices, rather than a de novo clinical trial with defined endpoints and acceptance thresholds for this specific device.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" and quantifiable "reported device performance" (e.g., sensitivity, specificity, accuracy) are not detailed for the Anokryo device itself. The primary "performance" assertion is that it is "safe and effective for its intended use and performs at least as well as the legally marketed predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The implicit criterion is "Substantial Equivalence" to predicate devices. | "The Anokryo Dilator is similar in design and identical in function and intended use to legally marketed rectal dilators such as the Anurex and Inamed Rhemo-D devices." |
| Implicitly, device must effectively achieve: - Dilation of the anal sphincter and canal - Relief of hemorrhoidal pain and itching - Reduction of bleeding - Promotion of healing of inflamed hemorrhoidal tissues | "Accordingly, MK Conquest International, Inc. has concluded that the Anokryo Dilator is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set or clinical study for the Anokryo device. Its submission is based on comparison to predicate devices, not on new clinical data. Therefore, sample size and data provenance are not applicable in the context of a new study for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no described test set or ground truth established by experts for a study of the Anokryo device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no described test set that would require an adjudication method.
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 device is a physical medical device (rectal dilator), not an AI-based diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance 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 medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new clinical study with ground truth establishment for the Anokryo device is described. The basis for safety and effectiveness is substantial equivalence to predicate devices, which would have had their own historical evidence.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set is relevant to this device's submission.
§ 876.5450 Rectal dilator.
(a)
Identification. A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.