Search Results
Found 1 results
510(k) Data Aggregation
(249 days)
The Contactspod is a sterile single-use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. It is not a replacement for your normal contact lens rub and rinse cleaning and disinfecting care regime. It is a clear solution and should not be used, if cloudy or discoloured. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
The Contactspod is a sterile single use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. The Contactspod comprises an injection mouided medical grade polypropylene case and medical grade TPE basket seal. The contactspod is pre filled with 5ml of multi-purpose solution. The MPS solution is supplied inside the moulded PP case with an aluminium / PE heatseal which is removed by the user. Once lenses are inserted into the solution a secondary seal is used to seal the case.
Here's an analysis of the acceptance criteria and the study details for the Viopti Ltd. Contactspod, based on the provided document:
The document does not explicitly state "acceptance criteria" for specific performance metrics in a clear, quantitative table as one might expect for a typical diagnostic device. Instead, it describes various tests performed to ensure the device's safety and performance and to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are implied by the successful completion and positive outcomes of these tests, leading to the conclusion of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria are not provided in the document for each test with corresponding reported device performance values, I will summarize the tests conducted and the implied successful outcome, which serves as the "reported performance" (i.e., the device met the objective of each test).
| Test Name | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Stand Alone Report (Sterility and Antimicrobial Activity) | Demonstrate sterility and effective antimicrobial activity over shelf life, challenging with standard microorganisms per EN-ISO 14729:2001. | The study aimed to investigate and presumably confirmed the sterility and possible antimicrobial activity in a shelf-life study of six different lots. (Implied successful outcome) |
| Design Verification Testing | Verify and validate product design and characterize performance across various mechanical and environmental stresses (hinge flexing, air pressure, temperature extremes, latch force, crush resistance). | Various tests were carried out to verify and validate the product design and characterize performance. (Implied successful outcome, e.e., no failures reported) |
| Microbial Load Comparison between Contact Lens Cases | Demonstrate the Contactspod's effectiveness as a one-use storage environment for contact lenses compared to other cases. | Concluded that the Contactspod would be an effective one-use storage environment for contact lenses. (Implied successful outcome) |
| Review of ISO 14534 - Ophthalmic Optics - Contact lenses and contact lens care products | Ensure compliance with applicable aspects of ISO 14534. | Contactspod is deemed to be compliant with applicable sections of the standard. (Implied successful outcome) |
| Usability - ISO 62366: 2008/ IEC 62366:2007 - Application of Usability Engineering to Medical Devices | Assess usability for compliance with ISO 62366/IEC 62366. | The Contactspod was assessed with regards to usability for compliance. (Implied successful outcome) |
| ISO 10993-1: Biological evaluation of medical devices – Guidance on selection of tests | Demonstrate biological safety in compliance with ISO 10993-1. | Testing and analysis demonstrated compliance to ISO 10993-1. (Implied successful outcome) |
| Overall Safety and Effectiveness | No adverse indications or results and performance within design specifications, demonstrating substantial equivalence to predicate devices. | The Contactspod indicated no adverse indications or results, performs within design specifications, and is substantially equivalent to the predicate device. (Overall successful conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
- Stand Alone Report: "six different lots of the Contactspods" were tested. The provenance is not explicitly stated but is implied to be laboratory testing ("tested in the lab"). The study type is interventional/in-vitro product testing.
- Other tests (Design Verification, Microbial Load, Usability, ISO compliance): No specific sample sizes (number of devices or cases tested) are provided for these tests within the summary.
- Data Provenance: The studies were conducted by Viopti Ltd., implying in-house or contracted laboratory testing, likely in the UK (company location). The data is retrospective in the sense that it was collected prior to this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to the assessment of a physical medical device like a contact lens case. The tests are primarily laboratory-based physical, chemical, and microbiological evaluations against established standards and protocols, not subjective human interpretations requiring expert consensus. For example, sterility is measured quantitatively, not by expert opinion.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation of a contact lens case involves objective physical, chemical, and microbiological testing, not subjective human judgment that would require an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on reader performance. This is not applicable to a physical contact lens storage case.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the "Stand Alone Report" described directly evaluates the device's intrinsic characteristics (sterility and antimicrobial activity) independent of human interaction. Other tests like "Design Verification Testing" also fall under standalone testing of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests is established by:
- Established laboratory tests and protocols: For sterility and antimicrobial activity, the ground truth is defined by the methods and standards outlined in EN-ISO 14729:2001 and other relevant microbiology standards.
- Engineering specifications and standards: For design verification tests, the ground truth is the pass/fail criteria defined by engineering and performance specifications (e.g., specific force tolerance, temperature limits, seal integrity).
- International Standards: For compliance reviews (ISO 14534, ISO 10993-1, ISO 62366), the ground truth is the set of requirements and guidelines specified within those international standards.
8. The Sample Size for the Training Set
Not applicable. The Contactspod is a physical medical device, not an AI/Machine Learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Ask a specific question about this device
Page 1 of 1