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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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The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use 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 West Intradermal Adapter, a medical device, and its 510(k) submission. However, it does not contain specific acceptance criteria or detailed study results that would allow for a table of acceptance criteria and reported device performance. The information is high-level and broadly states that performance testing was conducted.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study for West Intradermal Adapter

The provided 510(k) summary for the West Intradermal Adapter (K123588) broadly states that "Performance testing including bench, animal and simulated use was conducted to assess the safety and effectiveness of the Intradermal Adapter for the stated indications for use." It concludes that "Results of performance testing demonstrated that the Intradermal Adapter used as an accessory to the piston syringe is safe and effective in administering intradermal injections."

However, the document does not specify the acceptance criteria themselves, nor does it provide a detailed breakdown of the reported device performance against such criteria. Therefore, a table explicitly outlining acceptance criteria and reported performance cannot be constructed from the given text.

Below is a breakdown of the other requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Not provided in the document. The 510(k) summary states that performance testing (bench, animal, simulated use) was conducted and demonstrated safety and effectiveness, but it does not list specific quantitative or qualitative acceptance criteria, nor the detailed results achieved.

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

   • Test Set Sample Size: Not specified in the document.
   • Data Provenance: The general categories of testing mentioned are "bench, animal and simulated use." The country of origin and whether the data was retrospective or prospective are not specified.

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

   • This information is not provided in the document. Given the nature of a medical device accessory for injections, 'ground truth' in the AI/ML sense (e.g., expert consensus on image interpretation) is generally not applicable to this type of device submission. Performance testing for such devices typically involves assessing physical and functional attributes, not diagnostic accuracy requiring expert image review.

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

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., radiology reads) to establish ground truth or resolve discrepancies. For a physical medical device like an intradermal adapter, performance is usually evaluated against objective metrics (e.g., depth of penetration, stability, material integrity), not through human adjudication of interpretations.

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, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are interpreting data with or without AI assistance. The West Intradermal Adapter is a physical accessory, not an AI diagnostic tool, so an MRMC study is not applicable.

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

   • Not applicable. The device is a physical accessory, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.

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

   • For a physical medical device, "ground truth" would be established through objective measurements and observations during bench testing (e.g., dimensional accuracy, material strength, leakage tests) and through direct assessment of injection performance in animal or simulated use models (e.g., successful intradermal bleb formation, correct depth of injection). The document broadly mentions "bench, animal and simulated use" but does not detail the specific performance metrics or how "ground truth" for those metrics was established.

8. The sample size for the training set:

   • Not applicable/Not provided. The device is a physical accessory, not an AI/ML model, 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 a physical accessory device, the establishment of its ground truth is not relevant in this context.

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