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The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.

The Insulin Syringes are 0.3 mL, 0.5 mL, or 1.0 mL synnges designed for subcutaneous injection of a desired dose of insulin. The Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (25G, 26G, 27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm). The Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.

The provided document is an FDA 510(k) premarket notification for "Insulin Syringes," which are medical devices, not AI/ML-driven software with specific acceptance criteria related to a test set, expert ground truth, or MRMC studies. The document describes a traditional medical device (insulin syringes) and its substantial equivalence to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria, study design (test set, ground truth, expert adjudication, MRMC, standalone performance, training set details) for an AI/ML device is not available in this document. The document primarily focuses on:

• Device Description: Physical characteristics (volume, needle gauge/length, materials), intended use (subcutaneous injection of U100/U40 insulin).
• Modifications: Updates to packaging options and syringe sizes compared to the predicate.
• Substantial Equivalence Justification: Comparison of indications for use, technological characteristics (design, materials, sterilization) with predicate devices.
• Performance Testing: References to ISO standards for sterile single-use syringes, hypodermic syringes, stainless steel needle tubing, hypodermic needles, and sterilization validation (e.g., ISO 8537, ISO 7886-1, ISO 9626, ISO 7864, ISO 11135, ASTM F1980-16). These are standard tests for physical and functional properties of syringes, not AI/ML performance metrics.

The "Performance Testing" section refers to engineering and manufacturing standards for physical device performance, not for the performance of an algorithm or software. There are no mentions of AI/ML, image data, diagnostic accuracy, or human reader studies.

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The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe 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 of the skin. The device is intended to be used for adults only.

The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made of polypropylene.

The provided document describes the FDA 510(k) clearance for an Insulin Syringe (K233794). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria for an AI/ML algorithm.

Therefore, the information typically required to answer your request regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI/ML-powered device is not present in this document.

This document describes a medical device, an insulin syringe, which is a physical product, not an AI/ML software. The performance data presented refers to standard physical and biological tests for such a device (e.g., sterilization, biocompatibility, needle strength, etc.), not the performance metrics of an AI algorithm.

Here's a breakdown of why this document doesn't fit your request and what is actually discussed:

• Type of Device: The device is an "Insulin Syringe," a physical medical instrument for injecting insulin. It does not incorporate AI or machine learning.
• Purpose of the Document: This is an FDA 510(k) clearance letter. Its primary purpose is to establish "substantial equivalence" of a new device to a legally marketed predicate device, allowing it to be marketed. This is a common regulatory pathway for non-novel medical devices.
• "Acceptance Criteria" discussed: The "acceptance criteria" for a physical device like an insulin syringe are generally defined by recognized standards (e.g., ISO standards for sterile hypodermic needles, biocompatibility standards). The document states that performance testing was conducted "to ensure the substantial equivalence...and verify conformity to the applicable parts of ISO standards."
• "Study" discussed: The "study" refers to a series of performance tests (e.g., ISO 7864:2016, ISO 9626:2016, ISO 8537:2016 for physical characteristics; Biocompatibility testing as per ISO 10993-1; Sterilization, shipping, and shelf-life validation). These are laboratory and bench tests, not clinical studies involving AI models.

In summary, as the provided text is for a physical medical device (Insulin Syringe) and not an AI/ML-powered device, it does not contain the information you requested regarding acceptance criteria and study data for AI/ML performance.

To answer your prompt for an AI/ML device, you would need a document detailing the validation of an AI algorithm, which would include information on metrics like sensitivity, specificity, AUC, human-in-the-loop studies (MRMC), ground truth establishment, training data, and more. This document does not pertain to such a device.

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Insulin syringes are intended for subcutaneous injection of U-100 insulin

The insulin syringe consists of needle cap, barrel, plunger stopper, needle tube and plunger cap. It is sterile disposable, non-pyrogenic, easy to use and meets all of the required standards. The plunger cap is optional. The single insulin syringe in unit package lacks the plunger cap compared with the product in the multi-unit package. The needle cap is used to protect physical protection of the needle prior to use. The needle tube penetrates the patient's skin to inject fluid into the body. The plunger stopper is the sealing assembly that encloses mandrel component and is used to inject fluid into the body. The barrel is a tube-like and cylindrical structure that holds insulin before the injection. The plunger is the rod pushed down or up depending on clinical use. The plunger cap is used to protect plunger before use. The capacity of the insulin device is 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube is 26G, 27G, 28G, 29G, 30G, 31G, 32G and 33G. The needle length is 5 mm, 6 mm, 8 mm and 10 mm.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for an Insulin Syringe (K230061).

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

   The document lists the following performance tests and states that the proposed device was tested and demonstrated to be in conformance with the specified FDA recognized standards, and that the performance testing results met the standards' requirements to demonstrate the device's safety and effectiveness. No specific numerical performance values are provided, only conformance to standards.

   Acceptance Criteria (Standard)	Reported Device Performance
   ISO 8537-2016: Sterile single-use syringes, with or without needle, for insulin	Conforms to requirements for: Limits for acidity or alkalinity, Limits for extractable metals, Tolerance on the graduated capacity, Graduation lines, Numbering of scale, Scale interval units, Overall length of scale, Barrel and plunger stopper, Finger grips, Fit of plunger stopper in barrel, Dead space, Freedom from leakage past plunger stopper, Bond between hub and needle tube, Needle cap.
   ISO 7886:1-2017: Sterile hypodermic syringes for single use – Part 1: Syringes for manual use	Conforms to requirements for Lubricant of syringe.
   ISO 9626-2016: Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods	Conforms to requirements for: Stiffness, Resistance to Breakage, Resistance to Corrosion, Needle O.D., Needle inner diameter.
   ISO 7864-2016: Sterile hypodermic needles for single use - Requirements and test methods	Conforms to requirements for: Needle point, Patency of lumen, Cleanliness, Needle length, Lubricant of needle tube, Penetration force and drag force for needles.
   ISO 10993-1 (Biocompatibility)	Conforms to requirements for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogen, Subacute/Subchronic Toxicity, Genotoxicity. (For Externally Communicating Device, Blood Path Indirect, prolonged Contact (>24hrs to 30 days)).
   USP and USP (Particulate testing)	Met USP acceptance criteria.
   ISO 11135 (Sterilization)	Sterilization process validated, EO and ECH residual does not exceed limit according to ISO 10993-7.
   ASTM F1980-16 (Shelf-Life)	Verified claimed shelf-life of 5 years under accelerated aging conditions.
   ASTM D4169-16 (Package integrity - shipping)	All packaging deemed acceptable for protection of product and sterility maintenance.
   ASTM D3078-02 (Vacuum Leak Test)	Conforms to requirements.
   ASTM F 1929-15 (Dye Penetration Test)	Conforms to requirements.
   DIN 58953-6: 2016 (Microbial Barrier Properties Test)	Conforms to requirements.
   ASTM F88/F88M-21 (Seal Strength Test)	Conforms to requirements.
   FDA Guidance for Medical Devices with Sharps Injury Prevention Features, August 9, 2005 (Simulated Clinical Use Testing)	Conducted and demonstrated conformance.

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

   The document does not specify the exact sample sizes used for each test. For instance, for biocompatibility, it states testing was done in compliance with ISO 10993-1, but not the number of samples. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but the manufacturer is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in China.

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 information is not applicable and therefore not provided in the document. The device is a physical medical device (insulin syringe), not an AI/software device that requires expert adjudication for ground truth.

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

   This information is not applicable and therefore not provided in the document, as it pertains to AI/software device assessments.

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

   No MRMC study was done, as this is a physical medical device (insulin syringe) and not an AI-assisted diagnostic or imaging device.

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

   Not applicable, as this is a physical medical device.

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

   The "ground truth" for this device is conformance to established international and FDA-recognized standards for sterile single-use syringes and needles, verified through various physical, chemical, and biological tests. This includes mechanical properties, material safety, sterility, packaging integrity, and simulated use. There is no "ground truth" derived from expert consensus or pathology in the context of an AI/software device.

8. The sample size for the training set

   Not applicable, as this is a physical medical device, not an AI/software device that requires a training set.

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

   Not applicable, as this is a physical medical device.

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The product is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes.
The product is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

The Disposable Insulin Syringe is designed for subcutaneous injection of a desired dose of U-100 and U-40 insulin and has capacity of 0.3mL, 0.5mL, and 1.0mL. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, needle cap, plunger, piston, and plunger cap(only type A). The needle is a single ended lubricated stainless-steel cannula. The needle is covered by a polypropylene needle cap which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The piston is attached to the plunger and a Polypropylene plunger cap is placed over the plunger rod(only type A). All products are EO sterilized. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.

The provided submission is for a medical device (Disposable Insulin Syringe), not an AI/ML powered device. Therefore, a table of acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML is not applicable. The information requested (multi reader multi case study, standalone performance, ground truth establishment, training set sample size, etc.) pertains to AI/ML device evaluations and cannot be extracted from this document, which describes the testing and comparison of a traditional medical device against a predicate device.

The document discusses various performance data, including biocompatibility, sterilization, shelf life, and physical performance testing according to ISO and ASTM standards. These tests demonstrate the device's safety and effectiveness as a disposable insulin syringe, but not as an AI/ML system.

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Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.

The provided document is an FDA 510(k) premarket notification for an Insulin Syringe. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device, which is implied by your detailed request.

The document describes typical non-AI medical device testing, such as:

• Bench Testing: Verifies physical performance characteristics (e.g., needle tube length, bond strength, leakage, fit of plunger, dead space, penetration force, particulate contamination).
• Biocompatibility Testing: Assesses biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogens).
• Sterilization and Shelf-life Testing: Validates sterilization method and confirms shelf life.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria, performance metrics (like sensitivity, specificity, AUC), sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or training set details because this information is not present in the provided text. The device in question is a physical insulin syringe, not an AI/ML-based diagnostic or therapeutic device.

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Disposable syringe for insulin administration, for the patient with diabetes.

Insulin syringe with integrated extra thin stainless-steel needle and dead space less than 0.005 ml, made of medical grade plastic, sterile, disposable, pyrogen free and non-toxic. Sterilized by ethylene oxide. The product is composed of the following parts: Cylinder or barrel, Piston, Plunger, Needle, Needle cover or protector.

This document describes the acceptance criteria and study results for the "Insulin syringe with integrated needle DL®" (proposed device), demonstrating its substantial equivalence to a predicate device (Disposable Insulin Syringe, K162180).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards (ISO series) and national standards (MGA, NOM). The "Specifications" column represents the acceptance criteria, and the "Insulin syringe with integrated needle DLPJECT®" column represents the reported device performance.

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The Insulin Syringes without needle is intended for medical purpose in conjunction with sterile needle for the manual aspiration and injection of U100 insulin into subcutaneous tissues.

The Insulin Syringes without needle is a sterile and single use syringe intended for injection of U-100 insulin into the body, in conjunction with a sterile needle. The proposed device is available in 1 ml. The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in immediate package to maintain the sterility of the device during the shelf life of 5 years.

This document is a 510(k) Summary for a medical device called "Insulin Syringes without needle" (K221045) from Berpu Medical Technology Co., Ltd. It compares the proposed device to a predicate device (K162180) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance for a specific study. Instead, it describes adherence to recognized standards and successful completion of various tests. For the purpose of this request, I will synthesize the information into a table based on the non-clinical testing performed and the standards referenced.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for "test sets" in the context of clinical studies, as it explicitly states "No clinical study is included in this submission."

For non-clinical tests (e.g., performance, biocompatibility, sterilization validation, shelf-life, packaging), specific sample sizes used for testing are not provided in this summary. The data provenance would be from the manufacturer's internal testing or contracted laboratories performing tests according to the cited ISO and ASTM standards. This testing is typically prospective, performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical studies were conducted, and therefore, no expert-established ground truth for a clinical test set is relevant to this submission.

4. Adjudication method for the test set

Not applicable. No clinical studies were conducted, and therefore, no adjudication method for a clinical test set is relevant to this submission.

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

Not applicable. This device is an insulin syringe, not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned or would be relevant.

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

Not applicable. This device is an insulin syringe, not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is established by the specified international (ISO) and national (ASTM, USP) standards. The device is tested against these standards, and its performance is compared to the requirements outlined in those standards. For example, for particulate matter, the ground truth is the maximum particle count allowed by USP . For sterility, the ground truth is a SAL of 10^-6^ as per ISO 11135.

8. The sample size for the training set

Not applicable. No AI/machine learning component is involved, so there is no training set in this context.

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

Not applicable. No AI/machine learning component is involved, so there is no training set or corresponding ground truth establishment in this context.

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The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The provided text describes a 510(k) premarket notification for a medical device, the "Safety Insulin Syringe," not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML acceptance criteria and study design (such as training sets, test sets, expert adjudication, MRMC studies, etc.) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of the physical, chemical, and performance characteristics of the syringe itself, as well as its safety features.

However, I can extract the acceptance criteria and performance data that are relevant to this type of medical device submission.

Here's a summary based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (for a non-AI/ML medical device)

The device, a "Safety Insulin Syringe," is evaluated based on its physical, chemical, and safety performance. The acceptance criteria are typically compliance with recognized international standards and demonstration of specific functional parameters.

• Force to activate the safety mechanism: less than 5N.
• Force that the safety mechanism is destroyed (resist force): greater than 20N. | The safety feature performance test for the proposed device was evaluated, and the test result conforms to requirements of ISO 23908:2011 standards.
• "The force to activate the safety mechanism is less than 5N" was met.
• "The force that the safety mechanism is destroyed is greater than 20N" was met. |
  | Biocompatibility | Compliance with ISO 10993-1 for Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hours to 30 days). Testing includes: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, Subacute Systemic Toxicity. | Biocompatibility evaluated and results comply with ISO 10993 requirements. Specific tests conducted were: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, and Subacute Systemic Toxicity. |
  | Particulate Matter | Compliance with USP . | Testing performed and results not explicitly stated but implied to be compliant through lack of identified issue. |
  | Sterilization & Residues | Validation of sterilization per ISO 11135. Compliance with ISO 10993-7:2008 for EO and ECH (Ethylene Chlorohydrin) residue limits. Compliance with USP for Bacterial Endotoxin Limit. | Sterilization method validated per ISO 11135. Device found to be compliant with ISO 10993-7:2008 for EO and ECH residue and USP for Bacterial Endotoxin Limit. |
  | Shelf Life & Packaging Integrity | Shelf life of 5 years. Evaluation using physical, mechanical, chemical, and package tests on aging samples (validated using ASTM F1980-16 for accelerated aging). Simulated Transportation Test (ASTM D4169-16). Sterile Barrier Packaging Testing: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), Dye Penetration (ASTM F1929-15). | 5-year shelf life determined based on stability studies including accelerated aging. Simulated transportation test conducted according to ASTM D4169-16. Sterile barrier packaging tests performed: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), and Dye Penetration (ASTM F1929-15) – all implied to be compliant. |
  | Simulated Clinical Use (for Sharps Injury Prevention) | Evaluation of the safety mechanism according to FDA Guidance, "Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature" (August 9, 2005) and ISO 23908. Pre-established criteria for safe and effective activation and protection. | A simulated clinical use study was performed on 500 device samples. The results demonstrated that the proposed device met the pre-established criteria. |

Since this is not an AI/ML device, the following points are not applicable and are listed as "N/A":

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: N/A (for AI/ML test sets). For simulated clinical use of the physical device, 500 device samples were used.
   • Data Provenance: N/A (for AI/ML test sets, as no image/data input is being classified). The physical device performance testing was performed by the manufacturer, Berpu Medical Technology Co., Ltd. (China). The tests are non-clinical (laboratory/bench testing) and simulate real-world use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth based on expert review of data is established for this type of device).

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

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: N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (for AI/ML ground truth). The "ground truth" for this medical device is adherence to physical/performance standards (e.g., ISO, ASTM, USP) and functional testing parameters for its mechanical safety features.

8. The sample size for the training set: N/A.

9. How the ground truth for the training set was established: N/A.

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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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The Sterile Safety Insulin Syringes For Single Use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.

KDL Sterile safety insulin syringes have a sliding sleeve which is designed to shield the injection needle to protect the user from needle puncture and the sliding sleeve helps protect against needle puncture once activated. The sliding sleeve can be activated manually.

The provided text is a 510(k) summary for a medical device (Sterile Safety Insulin Syringes for Single Use) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in the format requested.

The document outlines conformity to various ISO standards and other regulatory requirements but does not detail a specific study with an acceptance criteria table, sample sizes for test/training sets, expert qualifications, or MRMC study results as one might expect for a diagnostic AI/imaging device. Instead, it describes a series of non-clinical tests to verify design specifications and compliance with recognized standards.

Therefore, many sections of your request cannot be directly answered from the provided text.

Here's what can be extracted and inferred:

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

The document lists several ISO standards that the device "complies with" or "conforms to." These standards inherently contain acceptance criteria, and the statement of compliance/conformance indicates that the device met these criteria. However, specific numerical acceptance criteria and reported device performance values are not explicitly stated in a consolidated table format in this document. Instead, compliance with the standard is the reported performance.

2. Sample size used for the test set and the data provenance

The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, specific sample sizes for these tests are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is generally relevant for studies involving human interpretation or subjective assessment, particularly in AI or imaging diagnostics. For a non-clinical device like a syringe, "ground truth" is established through physical and chemical testing against defined standards. Therefore, this information is not applicable and not provided in the document.

4. Adjudication method for the test set

Similarly, adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers interpret data that is then arbitrated. This is not applicable to the non-clinical testing of a syringe and therefore not provided.

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

An MRMC study is relevant for evaluating the impact of AI assistance on human performance, typically in diagnostic tasks. This document describes a physical medical device (syringe) and its non-clinical testing. Therefore, an MRMC comparative effectiveness study is not applicable and not performed/reported.

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

This question is also related to AI algorithm performance. As this document concerns a physical syringe, a standalone algorithm performance study is not applicable and not performed/reported. The non-clinical tests served as the "standalone" evaluation of the device's physical properties.

7. The type of ground truth used

For this device, the "ground truth" used for testing would be the specifications and requirements defined by the various ISO standards and USP . This includes physical dimensions, material properties, sterility, particulate matter limits, and biocompatibility criteria.

8. The sample size for the training set

This question is relevant for AI/machine learning models. For the non-clinical testing of a physical medical device, there is no "training set" in the AI sense. This information is not applicable and not provided.

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

Again, this is relevant for AI/machine learning. For this device's non-clinical testing, there is no training set. The "ground truth" for evaluating the device's conformance to standards is established by the scientific and regulatory consensus embodied in the ISO standards and USP monographs themselves. This information is not applicable and not provided.

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