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The Dynarex Eye Cup is a non-sterile device made of opaque Polyethylene designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye.

The Dynarex Eye Cup is a 12ml plastic cup, manufactured with polyethylene plastic that is designed to be filled with an eye wash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The cup is non-sterile and is re-usable.

The provided document describes the Dynarex Eye Cup (K151575) and its equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, a specific study proving those criteria, or details regarding sample sizes, expert involvement, ground truth, or comparative effectiveness studies.

The document makes a claim of "substantial equivalence" based on similar intended use, design, and biocompatibility testing. The "biocompatibility testing" is presented as the study proving safety and effectiveness, but no detailed results or comparative data against specific acceptance criteria for performance are provided.

Here's a breakdown of the information that is and is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device's function (washing/flushing the eye). The equivalence is largely based on material safety and basic design.
• Reported Device Performance: No quantitative performance metrics are provided. The "performance" is implicitly tied to its function of holding eyewash solution and being placed over the eye.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

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 an eye cup, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used: Not explicitly stated, as no performance study is detailed. The "ground truth" for the substantial equivalence claim relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set: Not applicable, as this is a physical device and not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

Summary of Bio-compatibility Testing (as presented as the "study"):

The document states one "study" was conducted, focusing on biocompatibility.

• Study Name/Type: Biocompatibility testing.
• Tests Performed: Acute Systemic Toxicity, In-Vitro Cytotoxicity, Ocular Irritation, and Maximization (sensitization).
• Results: "Results of the biocompatibility testing showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response."
• Conclusion: "All materials used in the manufacture of the Dynarex Eye Wash Cup have demonstrated to be substantially equivalent in regards to safety and effectiveness to the predicate device and are safe for its intended use."

Comparison Table as provided in the document (illustrates equivalence, not performance against criteria):

The document focuses on demonstrating that the Dynarex Eye Cup is substantially equivalent to a predicate device, as opposed to providing detailed performance data against specific, quantitatively defined acceptance criteria for its function. The "study" mentioned pertains solely to the biocompatibility of the materials.

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The Apothecary Products, Inc. Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.

The Flents Plastic Eye Wash Cup is a 0.65 fl. oz. (19 mL) plastic cup manufactured with Chi- Mei ABS PA-757 White plastic that is designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The Flents Plastic Eye Wash Cup is non-sterile and is reusable.

This document describes a 510(k) premarket notification for the Flents Plastic Eye Wash Cup, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one might for a novel diagnostic or therapeutic device. Therefore, many of the requested elements for describing a study proving performance against acceptance criteria are not directly applicable or present in this submission.

However, I will extract the relevant information where available and explain why other sections are not filled based on the provided text.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the Flents Plastic Eye Wash Cup does not present a study with specific performance acceptance criteria in the format typically seen for novel medical devices (e.g., diagnostic accuracy, efficacy endpoints). Instead, it demonstrates substantial equivalence to a previously cleared predicate device, K051414 (Tollot Pty. Ltd. (Aaxis Pacific) Eye Cup), primarily through biocompatibility testing and comparison of fundamental attributes.

The "acceptance criteria" are effectively the demonstration that the new device is as safe and effective as the predicate device such that no new questions of safety or effectiveness are raised. The "study" performed is biocompatibility testing of the materials and a comparison of design and intended use to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a relatively low-risk device, the "acceptance criteria" are implicitly met by demonstrating that the materials are biocompatible and the design and intended use are comparable to a legally marketed predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: For the biocompatibility testing, the sample size is not explicitly stated in the provided text (e.g., number of animals for in-vivo tests, number of cell cultures for in-vitro tests). It generally refers to the samples of the "Chi Mei ABS PA-757 White plastic" material itself, and possibly its colorant.
• Data Provenance: The biocompatibility testing was "performed by third-party laboratories." The country of origin for the data is not specified. The studies are assumed to be prospective in nature, meaning they were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: This information is not explicitly provided. Biocompatibility studies are typically conducted by qualified laboratory personnel following established standards (e.g., ISO 10993). The interpretation of results and overall conclusion of safety would be overseen by toxicologists or similar experts.
• Qualifications of Experts: Not specified in detail, but implied to be qualified personnel within the third-party laboratories performing the tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the context of biocompatibility testing. The "ground truth" for biocompatibility is determined by the results of the standardized biological tests themselves against accepted cytotoxicity, irritation, and sensitization criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic aids where human readers interpret output, and the goal is to quantify the improvement in human performance with AI assistance. The Flents Plastic Eye Wash Cup is a simple mechanical device; such a study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance Study: No, a standalone performance study (in the context of an algorithm's performance without human intervention) was not done. This is not an AI/algorithm-driven device. The "standalone performance" of the device itself relates to its physical properties and material safety, which was assessed through biocompatibility testing.

7. The Type of Ground Truth Used

• Ground Truth: For the "study" (biocompatibility testing), the ground truth is based on standardized biological test results and accepted criteria for biocompatibility (e.g., ISO 10993 standards). For the comparison to the predicate, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning or an "algorithm" in the sense that would require a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

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The Eye Cup Sterile I 's and the Eye Cup Non Sterile are each a cup that holds liquids, such as eye wash solution, used to flush out the eye.

a) Eye Cup Sterile 1's b) Eye Cup Non Sterile

The provided text is a 510(k) premarket notification letter from the FDA for an "Eye Cup Sterile 1's and Eye Cup Non Sterile" device. This document does not contain information typically found in a study or a description of acceptance criteria for an AI/CADe (Computer-Aided Detection) device.

The letter explicitly states that the device is an "Eye Cup" used to "flush out the eye." It pertains to a physical medical device, not a software algorithm. Therefore, the requested information about acceptance criteria for an AI device, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not applicable and cannot be extracted from this document.

The letter is a regulatory approval, confirming that the device is substantially equivalent to legally marketed predicate devices, and outlines general regulatory compliance. It does not include any performance data or study details for the device itself.

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The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye to help relieve discomfort caused by foreign material, air pollutants, or chlorinated water.

For Over-The-Counter use.

The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye.

The provided documents are FDA 510(k) letters for the Vista EYESHOWER, a single-use, disposable device for eye irrigation. These letters confirm the device's substantial equivalence to a predicate device but do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the given input. The documents are purely administrative communications regarding regulatory clearance.

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