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510(k) Data Aggregation
(63 days)
- The intended use is to expose the interior of the vagina
- The intended use is to maintain a clear and protected area of view
This device is to be used for exposing the interior of the vagina.
- The device is made of injected molded parts .
- The device assembly includes a window trap for pins to snap together ●
- The instrument has levels in the windows to lock positions as desired . by the expanding vertical blades
- The lateral blade protectors act to prevent lateral walls from cascading ● into view area.
- Lateral protector blades are same thickness of vertical blades thus act as rigid barriers
- Lateral protector blades conform with the design of vertical blade that . provide rigid conforming structures that allows smooth unchanged entrance
The device once snapped together do not require any further assembly - The device is for single use only
The provided text describes a 510(k) summary for the Nu-Spec D Vaginal Speculum. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way that would typically be associated with an AI/ML device or a device requiring new performance data.
Instead, the document focuses on substantial equivalence to a predicate device. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device that FDA has previously cleared.
Here's a breakdown based on the information provided, explaining why some sections of your request cannot be fully answered due to the nature of this particular 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Summary of Equivalence Claims) |
---|---|
Same intended use | The intended use is to expose the interior of the vagina and to maintain a clear and protected area of view. |
Manufactured through injection molding | Manufactured through injection molding. |
Made with same materials | Made with same materials. |
Maintain same rigidity for vaginal viewing | Maintain same rigidity for vaginal viewing. |
Both have clear plastic for viewing | Both have clear plastic for viewing. |
Share the same release mechanisms | Share the same release mechanisms. |
Share the same opening/closing and locking mechanisms in use | Share the same opening/closing and locking mechanisms in use. |
Both have same configurations for handling and gripping | Both have same configurations for handling and gripping. |
"Complies with all acceptance criteria listed above." | "Constructurally equivalent to the Cooper Speculum which has already been subjected to millions of applications." The new features (lateral wall protectors) are claimed to enhance safety and effectiveness without altering utilization. |
Explanation: In a 510(k) based on substantial equivalence for a physical device like a speculum, "acceptance criteria" are generally derived from the features and performance of the predicate device. The device is deemed "accepted" if it is shown to be substantially equivalent in design, materials, and intended use, and does not raise new questions of safety or effectiveness. The Nu-Spec D highlights its differentiating features (lateral wall protectors) as improvements without compromising equivalence in core functions.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This 510(k) summary relies on a claim of "constructural equivalence" to a predicate device that has undergone "millions of applications," rather than a specific test set of data for the Nu-Spec D itself. No new clinical or performance study data with a distinct test set is provided or referenced for the Nu-Spec D.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No new test set requiring expert ground truth establishment is referenced.
4. Adjudication Method for the Test Set:
Not applicable. No new test set requiring adjudication is referenced.
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 manual medical instrument (vaginal speculum), not an AI/ML device, and no MRMC study was conducted or is relevant to its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (the Cooper Speculum) through its extensive use in millions of applications, as well as the comparison of physical and technical characteristics.
8. The Sample Size for the Training Set:
Not applicable. No "training set" in the context of AI/ML or statistical modeling is relevant to this device submission.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As above, no training set or ground truth in that context is relevant.
In summary: The submission for the Nu-Spec D Vaginal Speculum leverages the established safety and effectiveness of a predicate device (the Cooper Speculum) through a claim of "substantial equivalence." The "study" proving it meets acceptance criteria is primarily an analysis of its design, materials, and intended use in direct comparison to the predicate, with additional claims that its new features enhance safety without altering core utilization. It is a traditional 510(k) submission for a physical, manual instrument, not a data-driven or AI-enabled device.
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