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Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.

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This document is a letter from the FDA regarding a change in product code for the "Finn Chambers Aqua" device. It is a reclassification notice and does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information based on the provided text. The document is administrative in nature and does not describe device performance or testing.

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allergEAZE clear Patch Test Chambers are an allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin. allergEAZE clear Patch Test Chambers are a intended for use by, or under the supervision of, a physician as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis.

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Here's an analysis of the provided text regarding the AllergEAZE™ Clear Patch Test Chambers, focusing on the absence of specific details related to device performance studies and acceptance criteria:

The provided FDA communication letters (K103409) do not contain information about acceptance criteria or a study proving the device meets those criteria, nor do they detail performance metrics, sample sizes, ground truth establishment, or expert involvement for such studies.

These letters primarily concern:

• An administrative change in the device's product code (K103409, a letter from November 1, 2024, updating the code from LDH to KXF).
• The original substantial equivalence (SE) determination (K103409, a letter from March 15, 2011).

The March 15, 2011, letter confirms that the device was found substantially equivalent to predicate devices, meaning it has similar intended use and technological characteristics to a legally marketed device and does not raise different questions of safety and effectiveness. This determination generally implies that the performance of the AllergEAZE™ Clear Patch Test Chambers is considered acceptable based on its similarity to existing, approved devices, rather than through a new, comprehensive performance study explicitly detailed within these documents.

Therefore, I cannot provide the requested information as it is not present in the provided input.

In a typical submission for a device requiring performance data, you would expect to see sections discussing:

1. A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative targets (e.g., sensitivity, specificity, accuracy, precision, durability, sterility, biocompatibility) and the results obtained from testing.
2. Sample size and data provenance: Details on the number of samples (patients, test units) used, whether the data was collected prospectively or retrospectively, and origin information.
3. Number and qualifications of experts: For studies involving expert review (e.g., image interpretation), information on the number of experts, their specialty, and experience.
4. Adjudication method: How disagreements among experts were resolved.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If the device assists human interpretation, this would compare human performance with and without the device.
6. Standalone performance: The performance of the algorithm or device without human intervention.
7. Type of ground truth: How the true status of each case was determined (e.g., biopsy, clinical follow-up, consensus of multiple experts).
8. Training set sample size and ground truth establishment: For AI/ML-driven devices, information about the data used to train the model, and how its ground truth was established.

Conclusion based on the provided documents:

The provided FDA letters for AllergEAZE™ Clear Patch Test Chambers do not contain the details necessary to answer your specific questions regarding acceptance criteria and performance study outcomes. The regulatory action is based on substantial equivalence to a predicate device, which usually means the detailed performance studies (if they were performed for the 510(k)) were not fully articulated in these summary letters, or that the performance was considered "substantially equivalent" rather than requiring new, detailed clinical performance data compared against specific metrics.

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Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin

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This is a 510k document for the AllergEAZE™ Patch Test Chambers. This document is a clearance letter from the FDA, not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. This letter does not describe a clinical study or performance evaluation in the way a scientific paper or a more detailed regulatory submission might.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate, rather than presenting a detailed performance study with acceptance criteria and a study design.

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Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing. This product is intended for use by or under the supervision of a physician in the testing of individuals suspected of having allergies. It is not intended for over-thecounter use.

Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing.

The provided text is a 510(k) premarket notification for the Finn Chamber® device, which is an aluminum holding device for allergen patch testing. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically associated with the evaluation of a device's performance against specific acceptance criteria.

The document primarily focuses on:

• Regulatory communication: An administrative change to the product code (K013820).
• Substantial Equivalence (SE) determination: A letter from the FDA stating that the Finn Chamber® is substantially equivalent to a legally marketed predicate device (IQ Chamber, K992553).
• Intended Use: "Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing. This product is intended for use by or under the supervision of a physician in the testing of individuals suspected of having allergies. It is not intended for over-the-counter use."

Since this is a substantial equivalence determination for a Class I device and not a performance study report, the requested information (acceptance criteria, study details, expert qualifications, etc.) is not present in the provided text. The FDA's determination of substantial equivalence for this device does not typically require the submission of clinical performance data in the same way that novel or higher-risk devices might.

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The IQ Chamber is an allergen delivery system which places allergens or allergen mixes in contact with the surface of the skin for the purpose of performing patch testing.

The product is a plastic tray with shallow indentations or chambers for use as a place allergens or allergen mixes in contact with the surface of the skin during allergen patch tests.

The provided documents pertain to the 510(k) premarket notification for the "IQ Chamber," an allergen delivery system. The initial FDA letter in 2000 determined the device to be substantially equivalent. A later letter in 2024 updated the product code.

However, the documents do not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, ground truth establishment, or any performance metrics that would typically be found in a study demonstrating a device meets acceptance criteria. The submission is focused on demonstrating substantial equivalence to a predicate device, not on presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The documents describe the device and its intended use, and state that it was found substantially equivalent to predicate devices, but they do not disclose the studies or data used to support thisequivalence or any specific performance criteria.

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EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.
EpiScreen is intended for use in the collection, preservation, and transport of oral fluid specimens.

The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosa. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

The provided text doesn't contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the EpiScreen Oral Specimen Collection Device, which primarily focuses on establishing substantial equivalence to existing predicate devices.

Here's what the document does include, which is related to the request but doesn't directly answer it:

1. A table of acceptance criteria and the reported device performance

• The document provides a "Comparison Table: EpiScreen, Saliva Sampler, Saliva Sac, and Salivette" which compares the indications and components of the EpiScreen device to three predicate devices. This table doesn't list acceptance criteria or performance metrics, but rather technological characteristics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided. The document focuses on regulatory classification and substantial equivalence, not a performance study.

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 provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided.

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 device is a specimen collection device, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable to a specimen collection device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• This information is not provided.

8. The sample size for the training set

• This information is not provided. There is no mention of a training set as this is not an AI-driven device.

9. How the ground truth for the training set was established

• This information is not provided.

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