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The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

The proposed Bifurcated Needle have two prongs. A small drop of smallpox vaccine was placed between the prongs and approximately fifteen punctures would be made into the skin. The needles were sterilized by EO to achieve a SAL of 10-6 and supplied sterile in packaging with a shelf life of five years.

The provided document is a 510(k) summary for a "Bifurcated Needle" and primarily focuses on proving substantial equivalence to a predicate device based on material properties, manufacturing processes, and adherence to performance standards. It explicitly states that "No clinical study is included in this submission." Therefore, the document does not contain information regarding a study that proves the device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or clinical effectiveness.

The request asks for details typically found in submissions for AI/ML-driven medical devices or diagnostic tools, which involve evaluating algorithm performance, human-in-the-loop studies, and the establishment of "ground truth" for test and training sets. Since this document is for a physical, non-AI medical device (a bifurcated needle for administering vaccines), these types of studies were not conducted or presented.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance in the context of AI/ML or diagnostic accuracy.
• Sample sizes for a test set for AI performance or data provenance.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• MRMC comparative effectiveness studies.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data) for AI performance.
• Sample size for training set for AI.
• How ground truth for training set was established for AI.

The "performance data" section in the document refers to biocompatibility, sterilization, shelf life, and general physical performance testing for the needle itself, against standards like ISO 10993, ISO 11135, and ASTM standards. This is for the device's physical properties and safety, not for diagnostic or AI/ML performance.

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Oryum and Ovem Epidermal Skin Prick Test Applicator is used for the percutaneous administration of diagnostic allergenic extracts.

Oryum and Ovem Epidermal Skin Prick Test Applicator is a sterile, disposable, multiple test head applicator used to administer skin test substances to the surface of the skin. The Oryum and Ovem Epidermal Skin Prick Test Applicator are used for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies. The Oryum and Ovem Epidermal Skin Prick Test Applicator is offered in several configurations with 1 to 12 test heads arranged in an asymmetrical design. Each of the test heads have a "leg." At the tip of each leg is an array of protruding test points (tines). The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin. This is an industry wide standard design. The test heads are designed to fit into the matching asymmetrical well design of a dipwell tray. The applicator loads the allergen from each well in the tray on to each test head. When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the test heads of each applicator is not intended to pierce the skin.

This is an FDA 510(k) summary for the Oryum and Ovem Epidermal Skin Prick Test Applicator. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through clinical trials. Therefore, the information provided focuses on comparative performance rather than extensive clinical efficacy studies with specific acceptance criteria as might be seen for novel devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical study endpoint with a pre-defined threshold. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing various technological characteristics and non-clinical performance aspects. The "performance" is implicitly deemed acceptable if it is comparable to the predicate device and meets recognized standards.

2. Sample size used for the test set and the data provenance:

• Biocompatibility Tests: The specific sample sizes for in vitro (cytotoxicity) and in vivo (sensitization, irritation, systemic toxicity) biocompatibility tests are not disclosed in this summary. These are typically performed on a sufficient number of samples as required by the ISO 10993 standards.
• Sterility Validation: The sample size for sterility validation (ISO 11737-2) is not specified. This involves a statistically significant number of units to demonstrate a SAL of $10^{-6}$.
• Shelf-Life Validation: The sample size is not specified. This typically involves real-time or accelerated aging studies on multiple samples.
• Shipping Performance: The sample size for ASTM D4169 is not specified but would involve a predefined number of packed devices.
• Performance Comparison with Predicate: The summary states "Internal method" for the comparison of allergen collection and delivery ability. No sample size (e.g., number of tests, patients, or trials) is reported for this internal performance comparison.
• Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests, nor whether they were prospective or retrospective. Given they are laboratory and bench tests, "prospective" or "retrospective" typically isn't applicable in the same way as clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is typically not applicable or not provided in the context of a 510(k) submission focused on non-clinical comparative performance. The "ground truth" for the non-clinical tests (like biocompatibility, sterility) is established by the test methods themselves and their adherence to international standards (e.g., ISO 10993, ISO 11737). The interpretation of results against these standards is usually performed by qualified laboratory personnel, but not typically "experts establishing ground truth" in the sense of clinical consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly those involving subjective interpretation of data (e.g., image reading), to establish a consensus "ground truth." The tests reported here are objective bench and lab tests based on standardized protocols where an adjudication process as described is not typically employed.

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 epidermal skin prick test applicator, a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies or human-in-the-loop performance with AI assistance are not relevant.

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

Not applicable, as this is a physical medical device and not an algorithm.

7. The type of ground truth used:

The "ground truth" for each non-clinical test reported is based on:

• International Standards: For biocompatibility (ISO 10993), sterility (ISO 11737), and shipping (ASTM D4169), the ground truth is defined by the objective pass/fail criteria stipulated within these respective standards.
• Predicate Device Comparison: For the "Performance comparison with predicate device" regarding allergen collection and delivery, the ground truth is established by the performance of the legally marketed predicate device (Multi-Test II K961918) as a benchmark.

8. The sample size for the training set:

Not applicable. This is a 510(k) for a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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The skin test applicator is used for conventional administration (percutaneous application of allergenic extracts directly onto the surface of the skin) of diagnostic allergen extracts for performing allergy skin tests on the typical sites (the back and the volar surfaces of the forearms) for hypersensitivity reactions in individuals suspected of having allergies.

The test tray is intended to hold allergenic extracts in a convenient arrangement for storage and use by the clinician.

The AllergiEnd allergy skin testing products are supplied sterile and consist of two (2) devices:

• Test Applicator
• Test Tray

The MedScience AllergiEnd Applicator and Tray are used together for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies.

The AllergiEnd ST-9 Applicator has nine (9) test heads arranged in an asymmetrical design two (2) rows of four (4) test heads and a distal ninth test head. The test heads are labeled 1 through 9.

Each of the 9 test heads has a "leg." At the tip of each leg is an array of nine (9) protruding test points (tines). The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin.

The test heads are designed to fit into the matching asymmetrical well design of the AllergiEnd ST-9 Test Tray. The applicator loads the allergen from each well in the tray on to each test head. The wells are numbered 1 to 9 to match the numbering on the applicator.

When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the 9 test heads of each applicator is not intended to pierce the skin.

The asymmetric design of the wells allows for only one possible orientation for the applicator to be placed in the tray. It is believed that the asymmetric design may help reduce the potential for operator error inherent in a symmetrical design and may also help the clinician avoid misreading of the skin reactions to the applied allergens.

The tray is configured to hold either 36 or 72 test allergens in individual wells. The groups of wells, either 4 groups for 36 test wells or 8 groups for 72 test wells, determine the tray configuration. The clinician's testing preferences will determine which tray configuration to consider.

The AllergiEnd ST-9 Multiple Well Test Tray is intended to hold small quantities of allergenic extracts in a convenient arrangement for storage and use. The Test Tray is not preloaded with allergens. The allergens are separately sourced and loaded by the clinician. Regardless of the number of wells, the test tray does not come in direct contact with the patient.

The individual wells are numbered with an easily readable alpha-numeric system to facilitate recording reactions to specific allergens. By including an alpha-numeric numbering system in the AllergiEnd ST-9 Multiple Well Test Tray the test administrator has a clear organizational structure for locating each allergen and tracking the patient's response and for correctly documenting in the patient's medical records.

The AllergiEnd ST-9 Multiple Well Test Tray also includes a locking lid that engages with a flexible seal. The locking/sealing cover protects the physician-filled allergenic material from contamination and evaporation. Additionally, the locking feature provides for secure handling. The locking feature does not affect the medical procedure, nor does it have any direct interaction with any of the allergenic extracts.

This document describes the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray. The device is intended for the conventional percutaneous application of diagnostic allergen extracts for allergy skin tests.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Effectiveness: Ability to administer allergenic extract percutaneously to elicit reactions comparable to the predicate device.	Mean wheal diameters of histamine and control (glycerin saline) showed no statistically significant differences between the subject device and the predicate device.
   Safety: Producing a comparable (or lower) sensation/pain rating as the predicate applicator when used to administer allergenic extract percutaneously.	The average pain rating for the AllergiEnd ST-9 Applicator was 1.54, which was comparable to the predicate device's pain rating of 1.55 (using the Wong-Baker FACES Pain Rating).
   Biocompatibility: Acceptable biocompatibility for limited duration skin contact.	Cytotoxicity, sensitization, and irritation tests demonstrated acceptable biocompatibility.
   Sterility: Sterility Assurance Level (SAL) of 10⁻⁶.	Sterilization validation (overkill approach, half-cycle method) achieved acceptance criteria.
   Inspection: AQL level 1.0 sampling size.	Each lot is inspected at AQL level 1.0 sampling size. (While stated, no specific performance metrics provided for this criterion beyond compliance with inspection.)

2. Sample size used for the test set and the data provenance:

   • Sample Size: 14 patients.
   • Data Provenance: Prospective, single-site clinical study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying a U.S.-based study or one compliant with U.S. regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document implies that the ground truth for "effectiveness" (wheal diameters) and "safety" (pain ratings) was established through direct measurement and patient reporting during a clinical study. It does not mention the use of external experts to establish a "ground truth" for the test set in the way one might for diagnostic accuracy; rather, it compares the device's performance to a predicate device and patient self-reported pain. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable as it would be for image interpretation tasks. The measurements (wheal diameter) are objective, and pain is subjective (patient-reported).

4. Adjudication method for the test set:

   • The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the clinical study. The effectiveness relied on comparing mean wheal diameters and pain ratings, which are quantitative measures rather than qualitative assessments requiring adjudication.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an applicator system for allergy testing, not an AI-assisted diagnostic tool for human readers.

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

   • No, this is a medical device, not an algorithm, and the performance is evaluated in direct user interaction for applying substances to the skin.

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

   • Effectiveness: The ground truth for effectiveness was established by measuring the mean wheal diameters resulting from the application of histamine and control solutions, compared directly to the predicate device's performance. This is an objective, physiological response.
   • Safety: The ground truth for safety was established through patient self-reported pain ratings using the Wong-Baker FACES Pain Rating Scale.

8. The sample size for the training set:

   • Not applicable. This device is a physical medical instrument, not an AI/ML algorithm requiring a training set.

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

   • Not applicable, as it's not an AI/ML algorithm.

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The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.

Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.

The provided document is a 510(k) premarket notification for the Allerhope® Allergy Skin Tester. It aims to demonstrate substantial equivalence to a predicate device, the Multi-Test II by Lincoln Diagnostics, Inc. However, this document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets these criteria.

Specifically, the document focuses on non-clinical testing for biocompatibility, sterility, and some performance aspects (flexural properties, Izod impact strength). It explicitly states that a "comparison test over allergenic extracts delivery function has been conducted," but it does not provide the acceptance criteria for this test, the detailed results, or the methodology (e.g., sample size, ground truth establishment, expert involvement, MRMC study details).

Therefore, I can only provide information based on what is available in the document.

Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available in the document:

Device: Allerhope® Allergy Skin Tester

Study Objective (as implied by 510(k)): To demonstrate substantial equivalence of the Allerhope® Allergy Skin Tester to the predicate device (Multi-Test II by Lincoln Diagnostics, Inc.) for the percutaneous administration of diagnostic allergenic extracts.

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for any of the performance tests, including the "allergenic extracts delivery function" comparison.
• Data Provenance: The tests were conducted to support a submission from a company in China (Zhengzhou, Henan, China). It is implied these were prospective tests performed specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable / Not Provided. The document describes non-clinical engineering and laboratory tests, not a clinical study involving human patients or expert interpretation of medical images/data to establish ground truth in the typical sense of an AI/human reader study. For the "allergenic extracts delivery function" test, the document does not specify who conducted the comparison or how the "can carry extracts" conclusion was reached in terms of expert involvement.

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

• Not Applicable / Not Provided. This type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads). The tests described are laboratory performance tests.

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:

• No. This document describes a 510(k) submission for a physical medical device (allergy skin tester), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed and is not relevant to this submission.

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

• Not Applicable. Again, this is not an AI algorithm. The performance tests would be akin to "standalone" performance of the device in a laboratory setting, but not in the context of an AI algorithm.

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

• For the biocompatibility and sterility tests, the "ground truth" is adherence to established international standards (ISO, USP).
• For the physical performance tests (Flexural Properties, Izod Impact Strength), the "ground truth" is adherence to specific ISO standards.
• For the "allergenic extracts delivery function" comparison, the ground truth is simply whether the subject device performs as well as the predicate device in carrying extracts. The methodology for determining this "truth" (e.g., a quantitative measurement, visual assessment, etc.) and the specific criteria are not detailed in the document.

8. The sample size for the training set:

• Not Applicable. This is not an AI device, so there is no training set in the machine learning sense.

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

• Not Applicable. As above, no training set for an AI model.

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The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
The BD Eclipse™ Bifurcated Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle.

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I am sorry, but based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets any specific acceptance criteria.

The documents are FDA letters regarding a 510(k) premarket notification for the "BD Eclipse Bifurcated Needle." These letters confirm the device's substantial equivalence to legally marketed predicate devices and reclassify its product code. They do not contain details about performance studies, acceptance criteria, or specific performance metrics.

Therefore, I cannot provide the requested information.

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The bifurcated allergy skin testing needle is indicated for in-vivo diagnostic skin testing using the puncture technique.

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This document is a 510(k) premarket notification letter from the FDA regarding a Bifurcated Allergy Skin Testing Needle. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for a typical AI/software device.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance. This type of clearance generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different characteristics that do not raise new questions of safety and effectiveness. It does not involve a multi-reader multi-case study, standalone algorithm performance, or detailed ground truth establishment as would be seen for more complex AI-driven medical devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria in the context of an AI-driven device.

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The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

The BD Bifurcated Needle will be offered in the following reorder numbers: 301754; 301755; 301756; 301757.

The provided text is a 510(k) premarket notification for a medical device: the BD Bifurcated Needle. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with detailed acceptance criteria, sample sizes, and ground truth methodologies as might be found in a PMA (Premarket Approval) application or a more complex de novo classification request.

Based on the provided document, the device is a BD Bifurcated Needle, which is intended for "administering vaccines by the scarification method or administering epidermal allergens."

Therefore, much of the requested information regarding acceptance criteria and performance studies, particularly related to AI/algorithm performance, multi-reader studies, and detailed ground truth establishment, is not applicable to this type of device and submission.

Here's an attempt to answer the questions based only on the available information:

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

The document does not explicitly state numerical acceptance criteria or report specific performance metrics from a formal study for the BD Bifurcated Needle. The equivalence determination is based on comparing "Labeling" and "performance claims" to a predicate device.

Table:

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

• Sample Size for Test Set: Not specified. The document does not describe a clinical test set with a specified sample size for performance evaluation.
• Data Provenance: Not specified. The submission relies on "equivalence determination" to a predicate device rather than novel clinical 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)

• Not applicable. The submission does not describe a study involving expert-established ground truth for a test set. This type of device (a needle) does not typically require such a ground truth establishment process for a 510(k) submission.

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

• Not applicable. No test set requiring adjudication is described.

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 a physical medical instrument (needle), not an AI-powered diagnostic or assistive tool. MRMC studies or AI assistance are not relevant.

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

• Not applicable. This refers to AI algorithms, which is not what the BD Bifurcated Needle is.

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

• Not applicable. No ground truth is established in the context of a new performance study. The "ground truth" for this 510(k) is implicitly the established safety and effectiveness of the predicate device to which it is being compared.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets "acceptance criteria" (in the context of a 510(k) for this type of device) is an equivalence determination to a legally marketed predicate device.

The document states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."

And in the "Summary of Safety and Effectiveness":
"The elements of comparison between the BD Bifurcated Needle and the Precision Medical Products predicate device are as follows: Labeling: The performance claims on the BD Bifurcated needle are equivalent to those of the predicated device, i.e.: Intended use, Single use, Sterile (including statement on package integrity), Package open instruction."

This means the submission relies on the established safety and effectiveness of the predicate device(s):

• Precision Medical Products - K012515
• BD Vacutainer® Brand Blood Collection Needle - Pre-Amendment

The "study" here is essentially the comparison and justification of substantial equivalence based on characteristics like intended use, design (implied by the device name, but not detailed in the provided snippets), and labeling claims, rather than a de novo clinical trial with specific performance metrics and acceptance criteria.

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The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard Bifurcated Needle to deliver vaccine or allergen to the patient.

The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism.

I am sorry, but based on the provided document, I cannot answer your request. The document is an FDA 510(k) clearance letter for a medical device (Univec Bifurcated Sliding Sheath Syringe), which confirms its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria for device performance, specific studies proving performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The document primarily focuses on regulatory classification and general compliance with FDA regulations, not detailed performance validation data.

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The bifurcated vaccinating needle is indicated for use in administering vaccine by the scarification method.

Bifurcated Vaccinating Needle

The provided text is an FDA 510(k) clearance letter for a "Bifurcated Vaccinating Needle." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you've requested.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the device was cleared because it was found to be "substantially equivalent" to an existing, legally marketed device, not because it underwent a new clinical trial or performance study against specific acceptance criteria. The FDA's 510(k) pathway often relies on demonstrating equivalence rather than requiring a full de novo study with novel acceptance criteria and detailed performance reporting.

Therefore, I cannot extract the requested information from the provided text.

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The device system is used for prick application of allergen extracts in the performance of skin testing.

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I am sorry, but the provided text is an FDA correspondence related to the classification of a medical device (AllerSharp™ Allergy Skin Tester) and does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested table and paragraphs based on the given input.

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