(172 days)
The MicroDose Injector is indicated for low volume ophthalmic injections into the subretinal space.
The MicroDose Injector is designed for low volume ophthalmic injection into the subretinal space. It consists of one (1)1mL syringe and one (1) connector, which is joined to VFC tubing that is attached to a pneumatic air source, enabling a surgeon control for administering subretinal injections. The device is supplied sterile and intended for single-use only and cannot be reused or resterilized.
This document is a 510(k) summary for the MedOne Surgical, Inc. MicroDose™ Injector. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Therefore, many of the requested sections (sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission, as they pertain to studies involving performance metrics like sensitivity, specificity, or reader agreement, which are not the subject of this 510(k). This submission primarily covers technical, safety, and functionality aspects to establish equivalence.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the typical sense of numerical performance targets (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes equivalence based on meeting various technical, safety, and functional testing requirements.
| Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | Meets ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogenicity) |
| Sterilization Assurance Level (SAL) | Achieves SAL of 10^-6 (ISO 11137-1 and ISO 11137-2) |
| Shelf-life | Established 5-year expiration date |
| Package Integrity & Functionality | All tests passed post-shipping |
| Intended Use | Same as predicate device (low volume ophthalmic injection into the subretinal space) |
| Technological Characteristics | Substantially equivalent to predicate device (K200325) in terms of materials, mode of operation (pneumatic), volume (1mL) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/available from the 510(k) summary. The "tests" performed are engineering and laboratory tests (biocompatibility, sterilization, shelf-life, package testing), not clinical or diagnostic performance studies with patient data.
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)
This information is not applicable/available. Ground truth as understood in AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant to the types of tests conducted for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/available. Adjudication methods are typically used in clinical studies involving human interpretation or consensus, which are not presented here.
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
This information is not applicable/available. The MicroDose™ Injector is a physical medical device (syringe system), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/available. The device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed can be characterized as follows:
- Biocompatibility: Established standards and validated laboratory methodologies (e.g., cell viability assays for cytotoxicity, skin reaction assessment for sensitization, animal models for systemic toxicity).
- Sterilization: Microbiological methods to confirm the absence of viable microorganisms to the specified SAL.
- Shelf-life: Real-time or accelerated aging studies with functional testing at intervals to determine the point at which the device no longer meets specifications.
- Package integrity: Physical testing (e.g., burst strength, seal integrity) according to recognized standards.
- Functionality: Direct measurement against engineering specifications (e.g., flow rate, volume delivery accuracy).
8. The sample size for the training set
This information is not applicable/available. There is no "training set" as this device is not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable/available. As there is no training set for an AI algorithm, there is no associated ground truth in that context.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).