(122 days)
The UroMed CaverMap® Surgical Aid is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open prostatectomy and colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
The UroMed CaverMap Surgical Aid combines the technologies of two devices into one contained unit. The CaverMap Surgical Aid incorporates a nerve stimulator and a penile rigidity (tumescence) monitor into a single unit. The device is designed for identifying exposed nerves during open prostatectorny and colorectal surgical procedures. The device aid's the surgeon in locating the cavernosal and sacral nerves, which both effect tumescence.
The provided 510(k) summary for the UroMed CaverMap® Surgical Aid does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
This document focuses on establishing substantial equivalence to a predicate device (K970971 UroMed CaverMap Surgical Aid) based on its intended use, indications for use, and a general description of its technological features. It also lists the standards achieved (e.g., FDA Quality Systems Regulation, ISO standards), which are related to manufacturing and design controls, but not directly to performance acceptance criteria for the device's function.
Therefore, for each of your requested points, the answer is that the information is not provided in the given text.
Here's a breakdown of why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states a general "Summary of Standards Achieved" related to quality systems and biological evaluation, not specific performance metrics.
- Sample size used for the test set and the data provenance: No performance study is described, hence no test set or information about its size or provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study is described, hence no ground truth establishment details.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No performance study is described.
- 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: No such study is mentioned. The device is a "Nerve Stimulator/Locator" and does not appear to involve AI or "human readers" in the context of diagnostic interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No performance study of this nature is described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No performance study is described.
- The sample size for the training set: No training set is mentioned as part of a performance study.
- How the ground truth for the training set was established: No training set is mentioned.
In summary, the provided 510(k) pertains to substantial equivalence based on established regulatory standards and a predicate device, rather than a detailed performance study with specific acceptance criteria and results.
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(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.