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510(k) Data Aggregation
(76 days)
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
The Dynarex Vaginal Specula is used to expose the interior of the vagina.
Indications For Use: This device is used to expose the interior of the vagina.
The Dynarex vaginal speculum is a non-metal (polystyrene), non-lubricated, hand held device used to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
The provided document is a 510(k) summary for the Dynarex Vaginal Speculum. It relies on demonstrating substantial equivalence to a predicate device (Dukal Vaginal Speculum, K020726) rather than presenting a study with explicit acceptance criteria and corresponding performance data. Therefore, many of the requested fields cannot be directly answered as they pertain to a different type of device evaluation (e.g., performance studies for novel devices or AI/software-as-a-medical-device).
Here's the information as it can be extracted from the document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Acceptance Criteria (based on Predicate) | Reported Device Performance (Dynarex Vaginal Speculum) |
|---|---|---|
| Indications for Use | Used to expose the interior of the vagina. | Used to expose the interior of the vagina. |
| Design | Injection Molded, clear plastic. | Injection Molded, clear plastic. |
| Materials | Polystyrene | Polystyrene |
| Performance | Substantially Equivalent (implies similar functionality to Dukal device) | Hand operated, multi-position |
| Sterility | Non-Sterile | Non-Sterile |
| Mechanical Safety | Substantially Equivalent (implies similar safety features to Dukal device) | Simple thumb adjustable lever action. |
| Lubrication | Non-Lubricated | Non-Lubricated |
| Packaging | Bulk Pack 10/Plastic Bag, and Individually wrapped. | Bulk Pack 10/Plastic Bag, and Individually wrapped. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device relies on substantial equivalence to a predicate, not performance testing with a specific 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 ground truth was established by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
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 is a non-AI, manual medical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-AI, manual medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device (Dukal Vaginal Speculum, K020726), demonstrated through its prior FDA clearance.
8. The sample size for the training set
- Not applicable. This device is not an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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