(44 days)
The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided document, K964848 (Wallace Artificial Insemination Catheters), there is no detailed study information or specific acceptance criteria for performance metrics as would be expected for a diagnostic or AI-driven device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with quantitative results.
Therefore, many of the requested sections (2-9) cannot be answered from the provided text as the information is not present.
However, I can extract the closest information to "acceptance criteria" based on the substantial equivalence argument, which implies that the device is deemed acceptable if it is comparable to the predicate device in terms of materials, sterilization, and intended use.
Here's the breakdown of what can be derived from the provided input:
1. A table of acceptance criteria and the reported device performance
Since specific quantitative performance acceptance criteria are not explicitly stated, the "acceptance criteria" are implied by the substantial equivalence argument – that the new device should be similar to the predicate device. The "reported device performance" is essentially the comparison to the predicate.
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance (Wallace Artificial Insemination Catheter) |
|---|---|
| Intended Use: For insertion of catheters and introduction of washed spermatozoa into the uterine cavity. | Meets this intended use. Explicitly states "intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity." |
| Material Composition: Polypropylene, Fluorethylenepropylene, Polyurethane. | Matches predicate: Polypropylene, Fluorethylenepropylene, Polyurethane. |
| Sterilization Method & Level: EO, SAL 10^-6. | Matches predicate: EO, SAL 10^-6. |
| Technological Characteristics: Finely smoothed tip, constant internal lumen to prevent embryo damage and ensure atraumatic technique. | "The ability of the Family of Wallace Artificial Insemination Catheter to meet its intended function includes the finely smoothed tip and constant internal lumen to prevent embryo damage and ensure atraumatic technique." (Implies it meets these features). |
| Safety and Effectiveness: Comparable to the predicate device. | "The safety and effectiveness of the Wallace Artificial Insemination Catheter are comparable to that of the other catheters [Edwards-Wallace Catheters]." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes a comparison of device characteristics, not a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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 not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth established for performance. The "ground truth" for the substantial equivalence claim is the characteristics of the predicate device (Edwards-Wallace Catheters).
8. The sample size for the training set
- Not applicable. This is not a device that relies on a training set in the AI sense.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).