(90 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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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.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).