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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 <787> and USP<790> (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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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.

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 extensively references international ISO standards (e.g., ISO 9626:2016, ISO 7864-1:2016, ISO 8537:2016, ISO 10993 series) and national standards (MGA, NOM-137-SSA1-2008, ASTM D4109-22). These standards typically specify the number of samples required for each test. For instance:

• ISO 10993 (Biocompatibility): Tests like cytotoxicity, irritation, sensitization, acute, subacute, and subchronic toxicity, and pyrogenicity often involve in-vitro (cell cultures) or in-vivo (animal models like Wistar rats) testing with specific animal group sizes outlined in the respective ISO parts. For example, Pyrogens in Table 3 mentions "The sum of the temperature increments of the test animals is 0.26 °C so the sample is considered apyrogenic," implying in-vivo testing.
• Physical/Performance Tests (e.g., Dimensions, Cannula adhesion, Hermeticity): These are typically performed on a statistically significant number of production samples according to the specific test methods outlined in the cited ISO standards. While exact numbers are not explicitly stated in this summary, the compliance with these standards implies that the required sample sizes were met.

The data provenance is not explicitly stated as "country of origin." However, the tests are conducted in accordance with international (ISO) and potentially national (MGA, NOM from Mexico, given the submitter's address) standards, suggesting these tests were performed in certified laboratories adhering to these guidelines. The studies appear to be prospective as they are testing the newly developed "Insulin syringe with integrated needle DL®" against established criteria.

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

This type of medical device (insulin syringe) does not typically involve human expert "ground truth" establishment in the same way an AI diagnostic algorithm might. The "ground truth" for the performance and biocompatibility tests is based on objective measurements and established scientific protocols as defined by the international standards (ISO) and regulatory guidelines (MGA, NOM, ASTM). The "experts" involved would be the certified laboratory technicians and scientists performing these tests and interpreting the results against the defined specifications. Their qualifications would be in analytical chemistry, microbiology, toxicology, materials science, and medical device testing, following Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) principles. The number of such professionals is generally defined by the laboratory's quality system and standard operating procedures for each test.

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

Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in subjective assessments for diagnostic devices (e.g., radiologists reviewing images). For this type of device, which relies heavily on objective physical, chemical, and biological testing, traditional adjudication methods are not applicable. The "adjudication" is inherent in the test methodology itself:

• Compliance with numerical specifications: If a measurement falls within the specified range, it passes.
• Qualitative observations: For tests like "Finish" (absence of defects) or "Cytotoxicity" (reactivity grade), trained personnel make observations and record results based on predefined criteria in the standard. If a result is deemed "Non-cytotoxic" or "Passes the Test" according to the standard's interpretation guidelines, it meets the criterion.
  The reporting of results as "Complies," "Passes the Test," or specific measurement within tolerance indicates that the results were directly compared to the acceptance criteria without a separate adjudication panel.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The "Insulin syringe with integrated needle DL®" is a physical medical device, not a diagnostic imaging or AI software product, so such a study would not apply.

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

No, a standalone (algorithm-only) performance study was not done. This concept is also specific to AI/software as a medical device (SaMD) where an algorithm makes a determination independently. The device here is a physical syringe. Its "standalone" performance refers to its intrinsic physical and biological properties as tested against the standards.

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

The ground truth for this device's evaluation is primarily established through:

• International Standards and Regulatory Specifications: The core ground truth is defined by the detailed requirements and test methods of standards like ISO 9626, ISO 7864, ISO 8537, ISO 10993 series, MGA, NOM, and ASTM. These standards define acceptable material properties, dimensions, performance characteristics, and biological compatibility limits.
• Objective Measurement and Analytical Testing: Laboratory tests provide objective data (e.g., dimensional measurements, force required for cannula adhesion, chemical residue levels, cell reactivity grades, animal physiological responses) which are quantitatively or qualitatively compared to the predefined acceptance criteria from the standards.
• Biological Endpoints: For biocompatibility, endpoints like cell viability (cytotoxicity), skin reactions (irritation/sensitization), and animal physiological responses (pyrogenicity, acute/subchronic toxicity) serve as the ground truth indicators as interpreted against the ISO 10993 series.

8. The sample size for the training set

This device does not involve machine learning algorithms, thus there is no "training set" in the context of AI. The "training" in the manufacturing process refers to process validation and quality control, ensuring that the manufacturing process consistently produces devices meeting specifications. The exact numbers of units produced and tested during process validation are not provided, but they would be governed by internal quality systems and relevant manufacturing standards.

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

As there is no AI training set for this physical device, this question is not applicable. The "ground truth" for the device's design and manufacturing process would refer to the adherence to verified design specifications, material inputs, and validated manufacturing procedures, all established through engineering principles, regulatory requirements, and quality management systems.

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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 <788>. 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 Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual retractable safety insulin 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.

(1) Insulin Syringe
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
(2) Insulin Syringe with Safety Retractable
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube, safety shield and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).

1. Acceptance Criteria and Reported Device Performance:

The document outlines the acceptance criteria by stating that the device "conforms with the requirements of ISO 7864 and ISO 8537" for performance, safety, and effectiveness, and "conforms to the requirement of ISO 10993 series Standards" for biocompatibility.

For the "Insulin Syringe with Safety Retractable," additional performance criteria specifically related to the safety feature are provided:

For the general Insulin Syringe and Insulin Syringe with Safety Retractable, the following criteria are implicitly met by conformance to the cited ISO standards. The "Reported Device Performance" column indicates that the device did conform to these standards.

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

The document does not explicitly state the sample sizes used for the non-clinical tests. It refers to standards like ISO 7864, ISO 8537, ISO 10993, ISO 9626, USP <788>, ASTM D4169, ASTM F1929, ASTM F88, and ISO 23908. These standards likely define the minimum sample sizes for relevant tests. The data provenance is implied to be from testing conducted by Jiangsu Micsafe Medical Technology Co., Ltd in China, as it is the submitting company. The studies are prospective in nature, as they involve testing the device to ensure it meets established standards.

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

The document does not mention the use of experts to establish a "ground truth" in the context of clinical or diagnostic studies. The evaluation is focused on demonstrating conformance to established international and national standards for medical devices. Therefore, the "ground truth" is defined by the technical specifications and performance requirements outlined in these standards. The experts involved would be the engineers, scientists, and technicians conducting the tests and interpreting the results in accordance with these standards. Their qualifications would align with the specific tests performed (e.g., biocompatibility specialists, mechanical testing engineers).

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements against predefined criteria in recognized standards, not subjective interpretations 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:

Not applicable. This is a medical device (insulin syringe) that does not involve "readers" or Artificial Intelligence (AI) for diagnostic or interpretive tasks. The studies are related to the physical performance, safety, and biocompatibility of the syringe itself.

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

Not applicable. This device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is defined by the established technical specifications and performance requirements detailed in the referenced international (ISO) and national (ANSI AAMI, ASTM, USP) standards. These standards set the benchmarks for characteristics like biocompatibility, sterility, physical dimensions, material properties, and safety features.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a physical medical device undergoing performance and safety testing. This document describes the testing of a finished product against established standards, not the training of a machine learning model.

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

Not applicable, as there is no training set for this type of device submission.

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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 provided document is a 510(k) summary for an Insulin Syringe and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

Key points from the document regarding studies and testing:

• No AI/ML Component: The device described is an "Insulin Syringe," a physical medical device, not an AI/ML algorithm. Therefore, none of the requested information regarding AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are applicable or present in this document.
• Non-Clinical Studies: The document details non-clinical studies performed to demonstrate substantial equivalence to a predicate device. These include:
  • Performance Testing: Conducted according to ISO 8537:2016 for sterile single-use syringes for insulin.
  • Biocompatibility Testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ASTM F 756-17, and USP <151> (Pyrogen test), USP <788> (Particulate matters).
  • Sterilization and Shelf-life Testing: Validated according to ISO 11135, with residue levels meeting ISO 10993-7. Shelf-life testing supported a 5-year shelf life.
• No Clinical Studies: The document explicitly states: "No prospective clinical trials were conducted in support of this 510(K)."

Since the request pertains to the acceptance criteria and study proving an AI/ML device meets them, and the provided document describes a conventional medical device (insulin syringe), the requested information cannot be extracted.

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