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510(k) Data Aggregation
(141 days)
APOTHECARY PRODUCTS, INC.
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.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Biocompatibility: No evidence of cellular or systemic toxicity, ocular irritation, or sensitization response for materials in contact with eyewash solutions and the eye. | Biocompatibility testing (Acute Systemic Toxicity, In-vitro Cytotoxicity, Ocular Irritation, Maximization Sensitization) showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response. All materials demonstrated safety for intended use. |
| Intended Use: Device holds liquids such as eye wash solutions to flush out the eye, similar to the predicate. | The Flents Plastic Eye Wash Cup's intended use is identical to the predicate device: "intended to hold liquids such as eye wash solutions, used to flush out the eye." |
| Design: Similar design to predicate, an ABS plastic receptacle for eyewash solutions. | Design is "similar" to the predicate, being an ABS Plastic receptacle for eyewash solutions. Dimensions and volume are specified. |
| Safety and Effectiveness: No new questions of safety or effectiveness raised compared to the predicate device. | Based on biocompatibility testing and comparison of attributes, the device is considered substantially equivalent in safety and effectiveness. Instructions for reusable, non-sterile use (washing before use) address a key difference. |
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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(15 days)
APOTHECARY PRODUCTS, INC.
The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.
The API Soft Grip Contact Lens Cases and Deluxe Contact Lens Cases are designed for storage of contact lenses with adjoining dual wells that have screw top caps. The cases are labeled with an 'R' or 'L' to distinguish right and left lenses. The Econo-Mate Contact Lens Cases have two adjoining wells with integral hinged, self-sealing caps in which respective contact lenses are immersed. The cases are also labeled with an 'R' or 'L' to distinguish right and left lenses. The cases are available in a variety colors.
The document provided is a 510(k) Summary for a contact lens case, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, and standalone algorithm performance, are not applicable.
However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, as described in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Attribute | Acceptance Criteria (from "test plan") | Reported Device Performance |
|---|---|---|
| Leak Test | Effective against leaking | All Soft Grip, Deluxe, and Econo-Mate contact lens cases meet leak test criteria and have demonstrated to be effective against leaking. |
| Biocompatibility | Safe for use in contact lens storage and disinfection | Demonstrated the materials are safe for use in contact lens storage and disinfection. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "All Soft Grip, Deluxe, and Econo-Mate contact lens cases" were subjected to the leak test, implying a representative sample of each model, but the exact number is not provided.
- Data Provenance: The document does not specify country of origin for the test data. The tests were performed by "third-party laboratories" for biocompatibility and presumably internally or by a third party for the leak test. The study appears to be prospective testing of newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is Not Applicable as the device is a contact lens case, not an AI/ML device requiring expert ground truth for image or data interpretation. Biocompatibility testing relies on standardized protocols and laboratory analysis, not expert consensus in the typical sense of AI/ML evaluation.
4. Adjudication Method for the Test Set
- This question is Not Applicable. Performance (e.g., leak integrity, biocompatibility) is determined through empirical testing and analytical methods, not through an adjudication process like those used for expert review of AI/ML output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- This question is Not Applicable. MRMC studies are used for evaluating diagnostic or prognostic devices often involving human readers and AI assistance. This device is a contact lens case for storage.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is Not Applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established through physical and chemical testing standards.
- For the leak test: The "ground truth" is whether the case physically leaks under specified conditions.
- For biocompatibility: The "ground truth" is adherence to established biocompatibility standards and tests (e.g., ISO 10993 series or equivalent) to determine material safety.
8. The Sample Size for the Training Set
- This question is Not Applicable. This device is a manufactured product, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is Not Applicable. As stated above, this is a physical product, not an AI/ML model requiring a training set.
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(149 days)
APOTHECARY PRODUCTS, INC.
For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the "Ezy-Travel Wristbands," an acupressure device. This letter indicates a finding of substantial equivalence to a legally marketed predicate device for the stated indications for use (relief of nausea).
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the device. The letter solely states that the device is substantially equivalent and can be marketed.
Therefore, I cannot provide the requested information from the given text. The document does not describe the acceptance criteria or a study that proves the device meets them.
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(148 days)
APOTHECARY PRODUCTS, INC.
Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.
Adult Silicone Ear Plug
The provided document is a 510(k) clearance letter for a medical device (Adult Silicone Ear Plugs). It does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to AI/algorithm performance.
Therefore, I cannot fulfill the request using the given input. The document is solely a regulatory approval for marketing the device, confirming its substantial equivalence to a predicate device.
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