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The product family of Xtract Solutions Syringe Keys are indicated as accessories provided for specified commercially available piston hypodermic syringes (for medical purposes) which are designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and other medications. The Syringe Keys (available for 1mL and/or 3 mL hypodermic syringes) are designed as an accessory only for the following syringes:
1 mL syringes:
. 1 mL Terumo SurSaver Mixing Syringes (SS01A2313T) and/or
. 1 mL Greer Optimix (GROM-23) SurSaver Mixing Syringe.
1.1.2 3 mL syringes:
. 3 mL VanishPoint (RTI10311) Syringes, 23g x 1"
. 3 mL BD SafetyGlide (BD305905) Syringes, 23g x 1" .
. 3 mL BD Integra (BD305271) Syringes 23g x 1"
. 3 mL BD Precision Glide (BD309578) Syringes 20g x 1" .
1.2 The device assists the user in withdrawing precise and accurate liquid volume withdraws from a vial. The Syringe Keys do not facilitate or assist the user with injecting the contents of the hypodermic syringe.
1.3 The Syringe Keys can be used by medical personnel as well as individuals who are not medical professionals; but, have been instructed in their use.
1.4 Syringe Keys will be available for specified piston hypodermic syringe models manufactured by designated syringe manufacturers.

The Xtract Solutions 3 mL Syringe Key is a hand held passive tool and an accessory designed to conveniently and ergonomically fit between the plunger thumb rest and the finger grip of piston hypodermic syringes. The 3 mL Syringe Key facilitates the user in obtaining rapid and accurate volumetric with-drawls from vials containing vaccines and other medications. The Syringe Key has been re-designed for ergonomic improvement for the user and to fit four (4) additional piston hypodermic syringes. The 3 mL Syringe Key is 5 inches long and is curved to fit comfortably in the user's hand. At the top of the Key on the underside are three features: Teeth, Groove, and Notch. The plunger is pulled slightly from the syringe barrel and the plunger thumb rest is then nested into a precise slot located at the proximal end of the Syringe Key. After seating the thumb rest in the Syringe Key, the syringe's barrel is moved backward against the proximal flat face of the Syringe Key.

The provided 510(k) summary for the "Xtract 3mL Syringe Keys" mainly focuses on establishing substantial equivalence to a predicate device and describing the device itself. It includes limited information regarding detailed acceptance criteria or a comprehensive study report. However, based on the available text, we can extract some information related to performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

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

The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds. However, the performance testing section details the process and presents example data for one of the syringe key types. From this, we can infer the implied performance objective related to volume accuracy and precision.

Note: The document states, "Performance data demonstrated that the 3mL Syringe Keys facilitate the user in obtaining more accurate, precise and reproducible volume draws as compared to the standard method or visualization procedure." This statement, while lacking specific quantitative acceptance thresholds, indicates that the product performed favorably.

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

• Test Set Sample Size: For the example data provided (BD 3 mL Integra Syringes), 2 syringes were tested, and 10 draws were performed for each syringe. This means a total of 20 data points were presented as an example. The document also mentions, "Weight measurement analyses were conducted on each of the different 3 mL Syringe Keys multiple times," implying more extensive testing was conducted, but specific numbers for all syringe types aren't provided in the given excerpt.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It describes the testing as part of the "Performance Testing" for the 3mL Syringe Keys, suggesting it was conducted prospective to the submission.

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)

This device is an accessory for controlling syringe plunger travel and obtaining accurate volumetric withdrawals. The "ground truth" for its performance is directly measurable physical quantities (volume/weight). Therefore, no human experts were required to establish ground truth in the way typically seen in diagnostic AI studies. The ground truth was established by direct physical measurement using calibrated instruments (weighing dishes).

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

Not applicable. As noted above, the ground truth was established through direct physical measurement, not expert opinion 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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted as described in the document. This type of study is relevant for AI systems involving human interpretation, not for a mechanical accessory like the Syringe Keys.
• Effect Size: Not applicable. The device is a mechanical aid, not an AI system. The document does state, "Performance data demonstrated that the 3mL Syringe Keys facilitate the user in obtaining more accurate, precise and reproducible volume draws as compared to the standard method or visualization procedure," suggesting an unquantified improvement over manual methods. However, this is not an effect size derived from an MRMC study.

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

Yes, the performance testing described appears to be a standalone (device-only) evaluation. The device's ability to control the plunger travel and facilitate accurate volume draws was tested directly by measuring the withdrawn liquid's weight. While a user operates the device, the core function tested is the device's mechanical precision in controlling the draw, rather than human interpretation or cognitive assistance.

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

The ground truth used was direct physical measurement. The volume of withdrawn liquid was determined by weighing the liquid dispensed into "tarred weighing dishes" after being drawn from vials containing H₂O.

8. The sample size for the training set

Not applicable. This device is a mechanical accessory, not an algorithm that requires a "training set" in the context of machine learning or AI. The design process involved "establishing an empirical (not just mathematic) relationship of plunger travel to dispensed volume (weight)," which informed the physical design ("Syringe Key Design" worksheet). This is a design and calibration process, not an AI training process.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth for training in that context. The design was informed by empirical data relating plunger travel to dispensed volume, with ground truth for that initial empirical relationship established through direct physical measurement (weight).

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