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The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline, and other aqueous solutions.

The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link). The barrel contains a fixed male luer connector, which is compatible with female luer hubs.

The Instylla Delivery Kit is a sterile, single patient use device intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions. The device consists of a double-barreled syringe holder which holds and couples two (2) 1mL commercially available needleless syringes with calibrated hollow barrels and movable plungers. A single plunger clip is attached to both syringe plungers to facilitate the simultaneous injection of two distinct fluids when depressed.

The syringes of the Instylla Delivery Kit are composed of polycarbonate. The plunger clip and holder are composed of Acrylonitrile Butadiene Styrene (ABS).

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Smart Caps are indicated for use as sterile tip caps with tamper-evident function for luer-lock syringes. The use time of the Smart cap should be ≤ 24 hours.

The Smart Cap is a tamper-evident syringe cap with a clear indication of cap removal to ensure sterility and reduce the risk of medical fluids being compromised accidentally or intentionally. Its assembly includes an outer cover, an inner cap and an inner ring. It is made of acrylonitrile butadiene styrene (ABS) and polypropylene (PP) and is sterilized by ethylene oxide.

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The VaporShield™ is a sterile, single-use, closed system transfer device (CSTD), incorporating a preassembled Drug Vial holder (DVH) and Syringe (1mL, 22GA). The preassembled device is intended for medication draw from a drug vial only. After medication draw, the DVH is removed from the syringe, and the syringe is used for direct injection of hazardous and non-hazardous medication via subcutaneous or intramuscular administration. The syringe incorporates a safety mechanism which automatically retracts the needle inside the device for drug containment, and prevention of accidental needlesticks and device reuse. The VaporShield mechanically prevents drug transfer external to the device to minimize individual and environmental drug exposure. The VaporShield is intended for use by medical professionals who prepare/administer injection(s) to adults and adolescents in healthcare facilities. The device is not intended for neonates (<28 days old), infants (< 2 yrs old), or children (> 2 yrs. old – 12 yrs. old). The VaporShield Device is not intended for Compounding, Reconstitution, Phlebotomy, Intravenous injection, Intraperitoneal injection, or Intrathecal injection.

The VaporShield closed system transfer device (CSTD) is sterile, for single use, and is intended for direct injection of hazardous or nonhazardous drugs. A single configuration includes a 1 mL syringe, 22G cannula, and is pre-assembled with a Drug Vial Holder (DVH). Preassembly of the syringe and drug vial holder components are interlocked via a flex tab snap-fit connection. During drug draw, the DVH ensures a stable connection between the drug vial and syringe. The VaporShield has three (3) settings, two for needle length, and one (1) for safety. The DVH can be removed from the syringe when the syringe is placed in locked setting.

The VaporShield includes a safety mechanism that is manually activated by full plunger depression. When activated, the safety mechanism retracts the needle inside the plunger rod for containment, preventing accidental needlestick, and disallowing device reuse.

Syringe is intended for parenteral injection (subcutaneous / intramuscular).

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These devices are intended to be used:

• to inject fluids into, or withdraw fluids from, the body.
• to administer and/or withdraw (aspirate) fluids/drugs.

These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device.

EXEL Disposable Syringes are piston syringes of a three-piece design, consisting of a barrel, plunger, and gasket. The tip of the syringe has a male connector (nozzle) for connection to other devices. The barrel includes bold, clear scale markings (graduations) for accurate dosage measurement. The EXEL Disposable Syringe models are differentiated by volume (Luer Lock, Luer Slip, or Luer Slip Eccentric). and by the type of connector at the syringe tip (Luer Lock, Luer Slip). Luer Slip connectors may be centric or eccentric (i.e., off-centered) with a push-on design, while Luer Lock connectors provide a secure threaded attachment to needles or other devices. Some models feature extended graduation markings beyond the nominal capacity, differentiated with smaller graduation marks.

EXEL Hypodermic Needles are single-lumen hypodermic needles which are sterile and intended for single use. They consist of a hollow, bevel-edged metal tube (the cannula) that is sharpened at one end and joined to a female connector (the hub) at the other end. The EXEL Hypodermic Needle models are differentiated by needle gauge and needle length.

EXEL Disposable Syringes with Needles consist of a piston syringe connected to a hypodermic needle. The models are differentiated by the needle gauge, needle length, syringe volume, and connection type (Luer Lock, Luer Slip, or permanently attached).

The EXEL Disposable Syringe with SecureTouch Safety Needle features a manually activated safety shield that covers the needle tip immediately after withdrawal to reduce the risk of needlestick injury.

All subject devices are operated manually.

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Verisafe Safety Ret retractable Insulin Syringes are intended for aspiration and subcutaneous injection of insulin. After injection, the needle can be retracted directly from the patient's skin into the syringe barrel to avoid exposure to a contaminated needle, thereby minimizing accidental needle stick injuries.

Safety Retractable Insulin Syringes is a sterile device consisting of a calibrated barrel, plunger, piston, push button, retraction cylinder, sealing ring, spring and a needle. It is made of plastic, stainless steel and silicone materials. Type 5 is a syringe with a fixed needle.

The needle cap color is used to indicate insulin concentration that red for U40 and orange for U100.

Safety Retractable Insulin Syringes is using plunger to fill syringe as well as discharge the fluid. After use, by continuing to press the push-button down to depress the plunger all of the way within the barrel, the safety mechanism will be triggered, then the needle tube, needle hub and retraction cylinder will be retracted into the barrel completely under the force of the spring to minimize the risk of accidental sharps injury.

Product is delivered sterile. Sterilization process is validated according to EN ISO 11135.

This is a single-use device. Safety Sterile Syringes is intended to be used in Professional Healthcare Facility,
Home Environment and Transport (Ambulatory) Environment.

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The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.

The StaClear Syringe is a sterile, single-use, manually operated piston syringe intended for general-purpose aspiration and injection of fluids by trained healthcare professionals. It is suitable for ophthalmic applications, including intravitreal injections. The syringe functions using standard positive-displacement mechanics, in which movement of the plunger creates pressure differentials to aspirate or expel fluid.

The StaClear Syringe is offered in the following configurations:

• SC250AN: Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and optional plunger cap.
• SC250LS: Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper.
• SC250LL: Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.

All three configurations were previously cleared under K243936. This submission introduces no changes to the device's design, dimensions, materials, or intended use. The only modification is the addition of a rigid PETG tray sealed with a Tyvek lid as an alternative sterile barrier packaging configuration.

The device's intended use, design, materials, sterilization method (EO), and labeled shelf life (5 years) remain unchanged.

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The Merit Syringe is used to inject fluids into, and withdraw fluids from, the body.

The Merit Syringe a standard three-piece piston syringe intended for general purpose injection and aspiration by a qualified clinician. The syringe is constructed of a calibrated, hollow, clear polycarbonate barrel into which is inserted a closely fitted movable ABS plunger with black silicone rubber piston seal (tip). The barrel is marked with standard graduations per ISO 7886-1 requirements and contains an ISO 80369-7 compliant fixed male luer, small-bore connector. The subject device is single use and is available in either an ethylene oxide (EO) or gamma-sterile configuration.

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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-Fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy.

The syringes are available in the following size and cap color.

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The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user.

The SmartPilot YpsoMate NS-A2.25 is an optional, battery operated, reusable device designed to be used together with a compatible autoinjector (a single use, needle based, pre-filled injection device for delivery of a drug or biologic into subcutaneous tissue). Figure 1 shows the SmartPilot YpsoMate NS-A2.25 with the paired autoinjector. The SmartPilot YpsoMate NS-A2.25 records device data, injection data and injection process status. The SmartPilot YpsoMate NS-A2.25 also provides guidance feedback to the user during the injection.

Note that the SmartPilot YpsoMate NS-A2.25 does not interfere with autoinjector function.

The provided 510(k) clearance letter details the substantial equivalence of the SmartPilot YpsoMate NS-A2.25 device to its predicate. While it lists various performance tests and standards met, it does not contain specific acceptance criteria values or detailed study results for metrics like sensitivity, specificity, or improvement in human reader performance. This document primarily focuses on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the predicate, due to similar technological characteristics and adherence to relevant safety standards.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC studies), and ground truth establishment (especially for AI-driven performance) cannot be extracted directly from this regulatory document. The information primarily pertains to hardware, software, and usability testing.

However, based on the provided text, here's what can be inferred or stated about the device's acceptance criteria and proven performance:

Device: SmartPilot YpsoMate NS-A2.25

Indication for Use: The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user. Specifically compatible with Novartis/Sandoz Secukinumab (Cosentyx).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with quantitative acceptance criteria and reported performance values for metrics typically associated with AI/software performance (e.g., sensitivity, specificity, accuracy of data capture in a clinical context). Instead, it focuses on meeting established engineering, safety, and quality standards.

Here's a summary of the types of performance criteria implied by the successful completion of the listed tests:

Note: The device's primary function is to "capture and record injection information that provides feedback to the user," and it "does not capture dosing information" or "electronically controlled dosing." Therefore, criteria related to dosing volume accuracy or AI interpretation of medical images/signals for diagnosis are not applicable to this device. The focus is on the accurate capture of event data (injection start/end, result) and providing timely feedback, as well as general device safety and functionality.

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

The document describes various types of tests (e.g., Biocompatibility, EMC, Software V&V, Mechanical, Lifetime, Human Factors), but does not specify the sample sizes used for each test dataset.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that Ypsomed AG is based in Switzerland and the testing references international and US standards, the testing likely involved a mix of internal validation, third-party lab testing, and possibly user studies in relevant regions. All tests described are part of preclinical (non-clinical) performance validation, making them inherently prospective for the purpose of demonstrating device function and safety prior to marketing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts in the context of establishing ground truth for the device's functional performance, as it is not an AI-driven diagnostic or interpretative device that relies on human expert consensus for its output. Its performance is evaluated against engineering specifications and physical/software functional requirements. The "Human Factors" testing would involve users, but not necessarily "experts" adjudicating correctness in the sense of accuracy for a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable. The device's performance is determined by meeting pre-defined engineering and regulatory standards and testing protocols, not by expert adjudication of its output, as it does not produce subjective or interpretative results like an AI diagnostic algorithm.

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

Not performed/applicable. An MRMC study is relevant for AI systems that assist human readers in tasks like image interpretation to demonstrate improved diagnostic accuracy. This device is an "Injection Data Capture Device" providing feedback and recording information; it does not involve human readers interpreting data that the device enhances.

6. Standalone (Algorithm Only) Performance

While the device has software and algorithms to detect injection events and provide feedback, the document does not report "standalone" performance metrics in the way an AI diagnostic algorithm would (e.g., sensitivity, specificity). Its performance is demonstrated through the verification and validation of its hardware and software components (e.g., ability to detect spring position, successful data transfer, correct LED/audible feedback). The "Influence Testing" evaluates its performance in conjunction with the autoinjector, proving it does not negatively interfere.

7. Type of Ground Truth Used

The ground truth for the verification and validation of this device is engineering specifications, physical measurements, and adherence to established regulatory and industry standards. For example:

• Biocompatibility: Measured against established thresholds for cytotoxicity, sensitization, and irritation.
• EMC/Safety: Compliance with current versions of IEC standards.
• Software V&V: Compliance with software lifecycle processes and cybersecurity standards, and correct execution of defined functions (e.g., data recording, feedback activation).
• Mechanical/Lifetime: Physical measurements (e.g., activation force, dimension checks), cycle counts, and functional checks after simulated use/aging.
• Human Factors: User performance and subjective feedback against usability goals.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of its direct function (data capture and feedback).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense (i.e., for learning to perform a complex, data-driven task like image recognition or diagnosis). Its functionality is based on programmed logic and sensor readings, not statistical learning from a large dataset.

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

Not applicable, as there is no "training set" for the type of device described. Input signals (e.g., from the inductive sensor about spring position) are processed based on predefined engineering parameters and logical rules to determine injection status, not learned from a dataset.

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Monoject Syringes with Luer tip are intended for single use by health care professionals for general purpose fluid aspiration and and/or injection.

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The provided FDA 510(k) clearance letter pertains to Monoject™ Syringes, which are physical medical devices (piston syringes) and not an AI/ML software device. Therefore, the concepts of acceptance criteria for algorithm performance, study methodology for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this document.

The letter indicates that the device has received substantial equivalence to legally marketed predicate devices, meaning it meets the safety and effectiveness requirements for its intended use, which is general purpose fluid aspiration and/or injection by healthcare professionals.

To answer your request, if this were an AI/ML device, the information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided FDA clearance letter. The letter itself is a notice of clearance, not a detailed technical report of the studies performed.

Therefore, I cannot extract the requested information from the provided document as it does not contain details about an AI/ML study or its performance criteria.

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