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The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.

The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. This system consists of an Intradermal Injection Needle and an Immucise Syringe. The system is made of common materials used in needles and syringes. The Immucise Intradermal Injection Needle is comprised of a needle base. The Immucise Syringe is comprised of a barrel, a gasket and a plunger. The sterile Immucise Intradermal Injection Needle and Immucise Syringe are packed separately and assembled prior to use. The Immucise Intradermal Injection System is operated by a manual process.

Here's a breakdown of the acceptance criteria and study information for the Immucise Intradermal Injection System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K181369) for an expanded indication (including infants). Therefore, the "acceptance criteria" are largely implied by meeting the same performance standards as the predicate, or by achieving successful outcomes in functionality tests.

2. Sample Size and Data Provenance for Test Set:

• Bench Test: No specific sample sizes for "non-aged and aged samples" are provided in this document, but it refers to the prior submission K181369. Data provenance is not explicitly stated beyond "performed in K181369."
• Animal Test: No specific sample sizes for the animal study are provided in this document. The data provenance is Terumo (Japan). The study was conducted specifically to support the expanded indication, suggesting it was prospective for this submission, though the methodology was based on a previous study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Neither the bench tests nor the animal studies described in this document involved human experts establishing ground truth in the way a clinical study with image interpretation might.
• For the animal study, the "ground truth" (e.g., successful wheal formation, validated injection depth) would have been assessed by trained personnel through observation and potentially histological analysis. No specific number or qualifications of experts are mentioned.

4. Adjudication Method for Test Set:

• This type of information (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation, such as radiology reads.
• For bench and animal studies (focused on objective measurements and physiological responses), such adjudication methods are not applicable. The assessment would be based on predefined protocols and measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• This device is a physical medical device (intradermal injection system), not an AI-powered diagnostic tool that human readers would use in conjunction with. The comparative effectiveness focused on technical performance against a reference device, not human reader improvement with AI.

6. Standalone (Algorithm Only) Performance:

• No, standalone performance was not done.
• Again, this is a physical medical device. The concept of "algorithm only" performance is not applicable here as there is no AI algorithm involved in its direct function. The device's performance is its physical function.

7. Type of Ground Truth Used:

• Bench Test: Physical and functional measurements against predefined specifications (e.g., durability, material properties, dimensional accuracy).
• Animal Test: Direct physiological observations (wheal formation) and histological evaluation for injection depth, based on in-house standards designed to confirm intended physiological effects of intradermal injection.

8. Sample Size for Training Set:

• This concept is not applicable for this device. This is a physical medical device, not a machine learning model that requires a training set. The "training" in the context of device development would refer to design iterations and engineering testing, not data used to train an algorithm.

9. How Ground Truth for Training Set Was Established:

• Not applicable, as there is no training set in the context of machine learning. The "ground truth" for the device's design and engineering would be established through established engineering principles, material science, and regulatory standards.

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The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 year to adults, as a guide for performing intradermal injections.

The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1mL allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique. The Intradermal Adapter has been designed to snap fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.

The provided text describes the 510(k) premarket notification for the "Intradermal Adapter" device. Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific performance metrics and their corresponding reported values. Instead, it describes a qualitative acceptance based on the device's ability to maintain a controlled injection depth, similar to its predicate device, and the intended expansion of its indications for use.

The "Performance Testing" section states:

"Results of performance testing demonstrated that the Intradermal Adapter, when used as an accessory to the piston syringe, can be indicated for administering intradermal injections to the indicated patient population."

And regarding injection depth:

"...the peer reviewed studies presented in this submission confirm through the acquisition of data from 485 pediatric patients, that the controlled design of the ID Adapter prevents an injection depth to greater than 0.75mm which is well within the epidermis + dermis layer necessary for successful intradermal injection in a pediatric patient age group."

Based on this, we can infer the primary acceptance criterion and reported performance:

Study Details:

1. Sample Size Used for the Test Set and the Data Provenance:

   • Sample Size: 485 pediatric patients.
   • Data Provenance: The data was acquired from "peer reviewed journal articles," indicating that the data is retrospective and originates from clinical research studies likely conducted in various countries/institutions depending on the journal articles cited. The document does not specify a single country of origin but refers to "medical literature obtained through peer reviewed journal articles."

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

   • The document does not specify the number of experts or their qualifications for establishing ground truth for the test set from the peer-reviewed studies. It references "peer reviewed journal articles" which implies expert validation inherent in the peer-review process, but not specifically for defining ground truth for this device's submission.

3. Adjudication Method for the Test Set:

   • The document does not mention a specific adjudication method like 2+1 or 3+1. The data was "acquired from medical literature" which would have established its own ground truth and validation methods within those original studies.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. The study described focuses on device performance validation and comparison to Mantoux technique, not on human reader improvement with AI assistance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

   • This device is a physical medical device (an adapter for a syringe), not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance is not applicable and was not done.

6. The Type of Ground Truth Used:

   • The ground truth for the injection depth was established through the "controlled design of the ID Adapter" and confirmed by clinical data from peer-reviewed studies demonstrating a consistent injection depth "well within the epidermis + dermis layer necessary for successful intradermal injection." This combines design specifications with clinical outcomes (successful intradermal injection).

7. The Sample Size for the Training Set:

   • This document describes safety and performance testing for a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" as understood in machine learning is not applicable here. The device's design and engineering principles, informed by prior knowledge and the predicate device, serve a similar function as a "training" phase for an algorithm.

8. How the Ground Truth for the Training Set was Established:

   • As stated above, the concept of a "training set" is not applicable. The device's design and functionality are based on principles established through prior engineering knowledge, the predicate device (K123588), and understanding of anatomical requirements for intradermal injections. The "ground truth" for its design and desired performance would have been established through biomechanical principles, anatomical knowledge, and validated clinical requirements for successful intradermal delivery.

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