(51 days)
The TomCat allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes, which may increase the pregnancy rate in couples with unexplained infertility
The TomCat IUI catheter is a 3 ½ french catheter with a length of 5 ½ ". This catheter expands in size in the proximal area to accommodate a syringe tip. It is made out of propylene of class VI Grade.
The provided document is a 510(k) Pre-Market Notification for a medical device (TomCat IUI catheter). It is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices, not a study proving the device meets specific acceptance criteria through clinical trials or performance metrics.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, and ground truth information) are not applicable or cannot be extracted from this type of document. The document focuses on comparing the technological characteristics of the TomCat IUI catheter to predicate devices.
Here's what can be extracted and a clear explanation of why certain information is not present:
Description of Device Acceptance Criteria and Supporting Study
The provided document describes a 510(k) Pre-Market Notification (K972245) for the TomCat IUI catheter. The purpose of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, not to establish novel acceptance criteria proven through a specific clinical study with performance metrics in the way a new diagnostic algorithm might.
The "acceptance criteria" in this context are the characteristics and intended use that allow the device to be considered substantially equivalent to already approved devices. The "study" is the comparison presented in the 510(k) submission against those predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of specific numerical performance metrics (like sensitivity, specificity, accuracy), the "acceptance criteria" here are the characteristics of the device that are deemed similar or equivalent to predicate devices. The "reported device performance" is essentially the similarity demonstrated in the comparative table.
| Characteristic | Acceptance Criteria (Equivalent/Similar to Predicate) | TomCat Performance (as claimed by applicant) |
|---|---|---|
| Indications for Use | Equivalent (E) | E (to listed predicates) |
| Target Population | Equivalent (E) | E (to listed predicates) |
| Design | Similar (S) or Equivalent (E) | S or E (to listed predicates) |
| Materials | Similar (S) or Equivalent (E) | S or E (to listed predicates) |
| Performance | Equivalent (E) | E (to listed predicates) |
| Sterility | Similar (S) or Equivalent (E) | S or E (to listed predicates) |
| Biocompatibility | Similar (S) | S (to listed predicates) |
| Mechanical Safety | Not Applicable (N/A) or Similar (S) / Equivalent (E) | N/A or S/E (to listed predicates) |
| Chemical Safety | Not Applicable (N/A) | N/A (to listed predicates) |
| Anatomical Sites | Not Applicable (N/A) or Equivalent (E) | N/A or E (to listed predicates) |
| Human Factors | Equivalent (E) | E (to listed predicates) |
| Energy Used/Delivered | Equivalent (E) or Not Applicable (N/A) | E or N/A (to listed predicates) |
| Compatibility w/ Environment | Not Applicable (N/A) or Similar (S) | N/A or S (to listed predicates) |
| Where Used | Similar (S) or Equivalent (E) | S or E (to listed predicates) |
| Standards Met | Equivalent (E) | E (to listed predicates) |
| Electrical Safety | Equivalent (E) or Not Applicable (N/A) | E or N/A (to listed predicates) |
| Thermal Safety | Not Applicable (N/A) | N/A (to listed predicates) |
| Radiation Safety | Not Applicable (N/A) | N/A (to listed predicates) |
(Note: The table above synthesizes the claims made in the "Summary comparing technological characteristics with other predicate devices" found in the document. The specific entry for "TomCat Performance" is derived from the "E" or "S" markings in the predicate comparison table, indicating the applicant's claim of equivalence or similarity to established devices.)
2. Sample size used for the test set and the data provenance:
- Not applicable. This document is a 510(k) pre-market notification, which relies on demonstrating substantial equivalence to existing legally marketed devices, rather than an independent clinical trial with a "test set" in the context of AI/diagnostic device performance studies. The comparison is based on the technical specifications and intended use of the new device against predicate devices.
- The data provenance is the applicant's comparison to established predicate devices, which are already marketed. This is not a "study" with a data set from a specific country or collected prospectively/retrospectively in the typical sense.
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 "test set" and thus no "ground truth" established by experts in the context of a new diagnostic algorithm's performance. The basis for approval is the comparison of the device's characteristics to already-approved predicate devices by the submitter, which is then reviewed by the FDA.
4. Adjudication method for the test set:
- Not applicable. As there is no test set or expert ground truth establishment described, no adjudication method would be detailed.
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:
- No. This is a medical device for intrauterine insemination, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is an IUI catheter, a physical medical instrument. The concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. Ground truth generation for a diagnostic algorithm is not relevant to a 510(k) submission for a physical medical device demonstrating substantial equivalence. The "truth" in this context is that the predicate devices are legally marketed and considered safe and effective for their intended use.
8. The sample size for the training set:
- Not applicable. This submission does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This submission does not involve a training set or ground truth establishment in the context of algorithm development.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).