(73 days)
The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.
The Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are packaged individually as a sterile, dried and compressed sponge. They are used to absorb fluids from the operative field in ophthalmic surgery. M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde.
This is a 510(k) premarket notification for a medical device, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided text.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device that was on the market prior to May 28, 1976, or has been reclassified. This pathway focuses on equivalence rather than clinical performance studies demonstrating meeting specific acceptance criteria as you might find in a clinical trial for a novel device.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined or reported in the document. The basis for clearance is "substantial equivalence" to predicate devices.
- Reported Device Performance: Not reported in terms of specific metrics (e.g., accuracy, sensitivity, specificity). The claim is that the devices are "identical in size, shape, material composition and intended use" to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified (clearance based on substantial equivalence to predicate devices) | Not specified (performance implicitly similar to predicate devices due to substantial equivalence) |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable/not provided. This document is a premarket notification for substantial equivalence, not a clinical study report with a test set.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth establishment for a test set is not part of a 510(k) substantial equivalence submission for this type of device.
4. Adjudication method for the test set
- Not applicable.
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 not an AI-based device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- Not applicable. For a 510(k) based on substantial equivalence for this type of device, the "ground truth" is essentially the established safety and effectiveness profile of the predicate device(s).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device and 510(k) Basis from the Text:
- Device Name: Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch.
- Intended Use: To absorb fluids from the operative field in ophthalmic surgery.
- Material: Formalized PVA sponge.
- Regulatory Basis: Substantial equivalence (510(k)) to predicate devices (Merocel Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears).
- Reason for Substantial Equivalence Claim: The M-PACT devices are "identical in size, shape, material composition and intended use" to the Merocel predicate devices. The only differences mentioned are in labeling and packaging.
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.