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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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The XTRACT Solutions Syringe Keys are indicated as accessories for specified commercially available piston hypodermic syringes (for medical purposes) and 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 medications. The XTRACT Solutions Syringe Keys are designed and should be used only with the Terumo SurSaver Mixing Syringes (product code SS01A2313T) and/or the Greer Optimix (GROM-23) SurSaver Mixing Syringes,

The XTRACT 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. Designed to fit the Terumo SurSaver and Greer Optimix (GROM-23) Mixing Syringes, the XTRACT Syringe System facilitates the user in obtaining rapid, accurate and precise volumetric draws from vials containing vaccines, allergenic extracts and medications. The Syringe Key Set contains eight (8) individual Syringe Keys which are attached together by a stainless steel round-bead chain. A set contains keys for the following volumetric draws: 0.05 mL, 0.10 mL, 0.15 mL, 0.20 mL, 0.25 mL, 0.30 mL, 0.50 mL, 1.00 mL. Channels in both surfaces of the Key run along the width from edge to edge. The syringe plunger's thumb rest is inserted at one edge of the channel, the plunger is pulled from the syringe barrel as it is placed in the channel and the finger rest of the syringe barrel is located on the opposite channel edge. Materials used to fabricate the XTRACT Syringe Keys are polymers that have a long use in medical devices such as white delrin (polyoxymethylene) and polyethylene.

The XTRACT Syringe Key System is designed to assist users in obtaining accurate, consistent, and precise volumetric draws from vials using specific hypodermic syringes.

1. Table of Acceptance Criteria and Reported Device Performance:

• Visual Dispensation (0.5 mL aim): Min ~0.47 mL, Nominal ~0.49 mL, Max ~0.51 mL.
• Syringe Key Dispensation (0.5 mL aim): Min ~0.44 mL, Nominal (not labeled, but falls within tighter range), Max ~0.49 mL.
  This visually indicates a tighter range and potentially improved accuracy for the Syringe Key. |
  | Physical Dimensions / Manufacturing Accuracy (First Article Inspection) | All dimensions must meet drawing specifications and requirements. | Confirmed by "First Article Inspection... to verify that all dimensions met drawing specifications and requirements as noted in Table No. 1."
  Table No. 1 shows measured channel distances for various mL volumes (e.g., for 0.1mL, Nominal: 0.7481 inch, Samples 1-3: 0.7475, 0.7475, 0.7470 inch). These values are very close to nominal, indicating adherence to specifications. |
  | Material Composition | Use of polymers with a long history in medical devices. | Materials used are "white delrin (polyoxymethylene) and polyethylene," which "have a long use in medical devices." |

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

• Sample Size:
  • For the volume withdrawal accuracy test: "Weight measurement analyses were conducted on each of the five (5) different Syringe Keys at a minimum of 3 times." This refers to 5 specific keys (likely corresponding to 0.1mL, 0.15mL, 0.25mL, 0.5mL, and 1.0mL as per Table No. 1 and the mass data), each tested at least 3 repetitions.
  • One table (on what appears to be page 6 of the original document) shows performance data for "Syringe Key" A, B, C, and D, with 3 repetitions each for 5 different key volumes (0.1mL, 0.15mL, 0.25mL, 0.5mL, 1.0mL). This would be 4 Syringe Keys * 3 repetitions * 5 volumes = 60 measurements for mass (which correlates to volume).
• Data Provenance: The studies were conducted by XTRACT Solutions, LLC. The context implies these were internal performance tests for FDA submission. Details on country of origin are not explicitly stated, but the submission is to the US FDA, and the company address is in Portland, OR, USA, suggesting the testing likely occurred in the USA. The testing appears to be prospective, specifically for this device's submission.

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

• There is no mention of experts being used to establish a ground truth for the performance testing. The "ground truth" for the volumetric accuracy was established by precise weighing of dispensed water, which is an objective measurement based on physical properties.

4. Adjudication Method for the Test Set:

• Not applicable, as the performance testing involves objective measurements (weighing dispensed liquid and physical dimensions) rather than subjective expert evaluation requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study compared the device's performance to "standard method or visualization procedure" (human activity without the device) and "Syringe Key dispensation" (human activity with the device), but it was not structured as a typical MRMC study designed to measure human reader improvement with AI assistance.
• Effect Size: While not an MRMC study, the performance data (summarized as Tables No. 2-6, and visually represented in Figures 5 and 8 for 0.5mL) indicates that the Syringe Keys lead to "more accurate, precise and reproducible volume draws." The visual data for 0.5mL (Figures 5 and 8) shows a narrower range for the Syringe Key Dispensation (0.44-0.49 mL) compared to Visual Dispensation (0.47-0.51 mL), suggesting an improvement in precision and potentially accuracy. However, specific effect sizes (e.g., percentage improvement) are not quantified in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. The device, the XTRACT Syringe Key, is a passive mechanical accessory. Its function is inherently "human-in-the-loop" as it assists a user in performing a task. There is no algorithm or standalone performance without human interaction.

7. Type of Ground Truth Used:

• The ground truth used for the performance testing of the Syringe Keys was based on objective physical measurement:
  • Volumetric Accuracy: Determined by weighing dispensed water ("liquid was drawn from the vials and dispensed into tarred weighing dishes and subsequently weighed"). The ideal weight for various volumes was pre-established (e.g., "Ideal (g)" values in the table on page 6).
  • Physical Dimensions: Verified against "drawing specifications and requirements" through a "First Article Inspection," which involves direct measurement of the manufactured keys.

8. Sample Size for the Training Set:

• Not applicable. This device is a mechanical accessory, not an AI/ML algorithm that requires a training set. The "design" process involved "establishing an empirical (not just mathematic) relationship of plunger travel to dispensed volume (weight)" and then using this data to "establish the ideal physical size of the syringe keys." This would be considered engineering design and calibration, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set in the context of an AI/ML algorithm. The "ground truth" for the design of the keys was established by empirical measurement of the syringe system's behavior (plunger travel vs. dispensed volume by weight).

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