(62 days)
The device system is for use in the prick/puncture application of allergen extracts The epicutaneous layer of the skin in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.
Prick/puncture application of multiple allergen extracts in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.
The device system is comprised of both single-use and reusable components. The device includes:
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- The Track a sterile, single-use, injection molded, plastic piece with four sites having four tines each, intended to deliver the allergens into the epicutaneous layer of the skin. The Track is injection molded from a thermoplastic polymer. The material has been tested to meet USP Class VI performance criteria for biocompatibility. The Tracks are packaged in a PETG tray sealed with a tyvek lid, eight Tracks per tray.
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- A reusable Handle designed to "pick-up" and hold one or two Tracks. The Handle is constructed of a plastic body, stainless steel metal screws, and spring, and a machined, extruded metal trigger/latch mechanism designed to engage and hold the Tracks.
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- A reusable polystyrene plastic Loading Tray designed to hold one Handle with attached Tracks, and eight vials of allergen extracts.
A. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance and Study Results |
|---|---|
| The GreerTRACK should elicit comparable reactions to the GreerPICK when applying skin test materials. | "Results confirm that testing with the GreerTRACK elicits comparable reactions to those elicited by the GreerPICK." The study measured the largest and orthogonal diameters for both erythema and wheal reactions for both devices, and these measurements were found to be comparable. |
| The GreerTRACK should elicit a reaction to a 10-fold dilution of the positive control (histamine). | "As for the GreerPICK, the GreerTRACK can elicit a reaction to a 10-fold dilution of the positive control that is intermediate between the positive and negative controls." The study used histamine at 5 and 0.5 mg/mL as positive controls, and the GreerTRACK demonstrated the ability to differentiate these concentrations. |
| The reaction from the positive control dilution should be intermediate between positive and negative controls. | "As for the GreerPICK, the GreerTRACK can elicit a reaction to a 10-fold dilution of the positive control that is intermediate between the positive and negative controls." The study successfully showed this differentiation using histamine (positive control) and glycerosaline (negative control). |
| The reaction from the positive control dilution should be clearly distinguishable from the negative control. | "As for the GreerPICK, the GreerTRACK can elicit a reaction to a 10-fold dilution of the positive control that is intermediate between the positive and negative controls, and is clearly distinguishable from the reaction associated with the negative control." The study confirmed the distinctness of the positive control reaction from the negative control. |
B. Sample sizes used for the test set and the data provenance
- Sample Size (Test Set): 12 individuals.
- Data Provenance: Not specified, but generally, clinical trials for FDA submissions are prospective and conducted in the country of origin (likely the USA given the FDA submission).
C. 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. The document describes measurements taken of skin reactions (erythema and wheal), which are objective measurements, but it doesn't explicitly state who performed these measurements or their qualifications, nor does it specify if multiple experts established a "ground truth" through consensus for these measurements.
D. Adjudication method for the test set
- This information is not provided in the document. The document mentions measurements were "made and tabulated" but does not detail any adjudication process for these measurements.
E. 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 was not an AI device, and therefore, an MRMC study related to AI assistance was not conducted. This study compares two medical devices (GreerTRACK vs. GreerPICK) for skin allergy testing.
F. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual skin testing system, not an algorithm, so a standalone algorithm performance study was not conducted.
G. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was established by direct clinical observation and measurement of physiological reactions (erythema and wheal sizes) to standardized positive (histamine at different concentrations) and negative (glycerosaline) controls. This is essentially an objective, measured response to known stimuli, rather than an "expert consensus" on a diagnosis, pathology, or long-term outcomes data in this context. The expectation is that histamine causes a reaction and glycerosaline does not.
H. The sample size for the training set
- Not applicable. This device is a physical medical device, not a machine learning algorithm, and thus does not have a "training set" in the context of AI.
I. How the ground truth for the training set was established
- Not applicable. As there is no training set for this physical medical device, there is no ground truth established for it.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).