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The Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body.

The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin.

The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

• Disposable Sterile Syringe, with/without needle; luer/luer-lock: Piston, Plunger, Barrel. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Length 83-152mm, Diameter 50-31mm, Tip type luer/luer-lock, Needle tip configuration long bevel angle, Nozzle type Luer / Lock, 6% conical, 1,2 mm, Barrel marking specs 0.01ml-0.5ml, Graduation legibility Legible, Needle cover color Transparent, Lubricant composition Dimethicone, Barrel transparency Transparent/ UV resistant, Needle cover strength 15N (min. 2N max. 15N), Hub/needle bond strength min. 22-69 N. Complied with ISO 7886-1, ISO 7864, ISO 9626. Volume 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G. Needle Lengths 13-38 mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material PP, SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

• Sterile Insulin Syringe for Single use, with needle: Needle Cap, Needle, Piston, Plunger, Barrel, End Cap. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Complied with ISO 8537. Volume 0.5ml, 1ml volumes with fixed needle. Needle Lengths 8mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material SUS304, Needle Cap material PE, End Cap material PE. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Subchronic Toxicity, Hemolytical effect).

• Sterile Hypodermic needle for Single use: Protective cap, Needle, Adhesives, Needle hub. EO Sterilized. Prescription use. Medical professionals and trained care givers. Protective cap, Needle, Adhesives, Needle hub. Single use. For Manual Use Only, For Single Use only. Complied with: ISO 7864, ISO 9626. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G. Needle Lengths 13-38 mm. Protective cap materials PP, Adhesive Epoxy resin, Needle Hub materials PP, Needle material SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

The provided text is a 510(k) summary for medical devices (syringes and needles). It does not describe a study involving an AI model or a device that uses AI. Instead, it focuses on demonstrating substantial equivalence of the submitted devices to a predicate device through performance testing against established international standards for medical devices.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document. The document primarily details the physical and performance specifications of the syringes and needles themselves.

To directly answer your request based on the provided document, I must state that the information related to AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not present in the provided text. The document describes a traditional medical device submission, not an AI/ML-enabled medical device.

However, I can extract the acceptance criteria and performance data for the physical medical devices described:

Acceptance Criteria and Device Performance for Physical Medical Devices

The acceptance criteria for these devices are defined by compliance with a series of international ISO standards and USP guidelines. The "device performance" is reported as having "complied with" these standards. No specific quantitative performance metrics (e.g., accuracy, precision, etc.) are provided in a numerical table format for an AI algorithm, as this is not an AI device.

Table of Acceptance Criteria and Reported Device Performance

Regarding an AI-enabled device and its study, the following information is NOT available in the provided document:

• 1. Table of acceptance criteria and reported device performance for an AI model: Not applicable, as this is not an AI device.
• 2. Sample size used for the test set and data provenance: No test set for an AI model is mentioned. The performance testing refers to physical tests on the medical devices themselves.
• 3. Number of experts used to establish ground truth & qualifications: Not applicable for an AI model's ground truth. The ground truth for the physical devices' performance is established by the specifications and test methods within the referenced ISO standards.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No prospective clinical trials were conducted in support of this 510(K)."
• 6. If a standalone (algorithm only) performance was done: Not applicable, as there is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical devices, the "ground truth" is adherence to established engineering and material standards for safety and performance (e.g., fluid aspiration/injection, material biocompatibility, sterility).
• 8. The sample size for the training set: Not applicable, as there is no AI model.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI model.

In summary, the provided document details a 510(k) submission for conventional medical devices (syringes and needles) and their compliance with relevant international standards, not an AI-enabled medical device. Therefore, the specific criteria requested for AI devices are not found within this text.

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