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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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Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only.

Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.

The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.

The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

This document describes the premarket notification for Bio Protech, Inc.'s Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, and Disposable Hypodermic Needle Electrodes. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating similar performance characteristics to predicate devices and adherence to relevant standards. The "Substantial Equivalence Chart" (Pages 5-7) directly compares the new device with predicate devices across various characteristics.

For "Performance", the report states:

• Acceptance Criteria (Implied): Equivalent penetration and friction force to predicate devices, and electrical properties conforming to DIN 13097. Assurance of functionality during the shelf life through aging tests. Optimal bevel and burr for sharpening, and electrical continuity and isolation of all poles.
• Reported Device Performance:
  • Disposable Concentric Needle electrodes: "Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product."
  • Disposable Hypodermic Needle electrodes (under the "Performance" row for Concentric, but appears to relate to Hypodermic based on context within the table): "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"
  • Disposable Monopolar Needle electrodes / EP Needle electrodes: "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"

The overall conclusion states: "The result of testing shows that the electrodes are as safe, effective and perform at least as the legally marketed device."

Summary of Studies and Information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • The document does not specify the sample sizes used for the bench testing (penetration, friction force, electrical properties, aging, EO residual, biocompatibility).
   • Data Provenance: The accelerated aging testing was conducted by KTR (Korea Testing and Research Institute). Biocompatibility evaluations were performed for manufactured and sterilized Bio Protech electrodes. The provenance of the specific test samples (e.g., country of manufacture) is not detailed beyond the company's location in Republic of Korea. All testing appears to be prospective testing of the Bio Protech device.

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

   • This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring expert interpretation of medical images or patient data to establish ground truth.

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

   • This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring adjudication of medical interpretations.

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 or comparative effectiveness study involving human readers or AI assistance was conducted or described in this document. This device is a disposable needle electrode, not an imaging or diagnostic AI device.

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

   • No standalone algorithm performance study was conducted. This device is a physical medical device (needle electrodes), not an algorithm or AI.

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

   • For the performance testing, the "ground truth" or reference was based on established industry standards (e.g., DIN 13097 for mechanical and electrical properties, ASTM F 1980 for aging, ISO 10993 for biocompatibility, ISO 10993-7 for EO residuals) and direct comparison to the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

   • This question is not applicable as there is no mention of a training set or an algorithm in this submission.

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

   • This question is not applicable as there is no mention of a training set or an algorithm in this submission.

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FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. . The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) The needle cap covers intended to provide physical protection to the needle tube.

The provided text describes a 510(k) premarket notification for a disposable hypodermic needle named FEELject NEEDLES, seeking substantial equivalence to a predicate device. The information focuses on the regulatory submission process and general device characteristics, not on a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested sections about a detailed study simply cannot be filled from the provided text.

Here's what can be extracted and what information is missing:

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

Missing Information:

• Specific quantitative limits or thresholds for "acceptance criteria" for biocompatibility, sterility, or pyrogenicity are not provided. The document only states that tests were performed and the device passed or met the requirements.
• Detailed performance metrics or quantitative results for fluid injection/aspiration are not provided. The phrase "performs in a substantially equivalent manner" is used.

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

Missing Information:

• Sample size for the test set: Not mentioned.
• Data provenance: Not mentioned.

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)

Not Applicable / Missing Information:

• This type of expert-driven ground truth establishment is typically relevant for diagnostic or image-analysis devices. For a hypodermic needle, "ground truth" would be objective measurements and qualitative assessments from bench testing and manufacturing standards, not expert adjudication in the same sense.
• No experts are mentioned as being involved in establishing ground truth for the performance tests.

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

Not Applicable / Missing Information:

• Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, often in clinical trials or image reading studies. This is not relevant for the type of bench testing described for a hypodermic needle.

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 / Missing Information:

• An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is a hypodermic needle, and no AI component or human interpretation study is mentioned.

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

Not Applicable / Missing Information:

• This refers to AI algorithm performance. The FEELject NEEDLES is a physical medical device, not an algorithm.

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

• Type of Ground Truth: For the performance described, the ground truth would be based on standardized test methods and specifications for medical devices, specifically hypodermic needles. This includes established physical, chemical, and biological test methods to assess properties like biocompatibility, sterility, pyrogenicity, and mechanical integrity (e.g., sharpness, flow rate, hub-needle bond strength). The document implies adherence to these standards to achieve substantial equivalence.

Missing Information:

• Specific details of these standards or how individual ground truth values were established for each test are not provided.

8. The sample size for the training set

Not Applicable / Missing Information:

• Training sets are for machine learning algorithms. This device is a physical hypodermic needle, not an AI model.

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

Not Applicable / Missing Information:

• As above, training sets are not applicable to this device.

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To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.

TSK STERIJEKT is a sterile Hypodermic Single Lumen Needle, packaged individually for single patient use. It consists of a stainless steel beveled cannula bonded to a plastic hub. Sizes include 14G-31G and various lengths. The needle is intended to fit any luer lock or luer slip syringe tip.

This document describes a 510(k) summary for the TSK STERIJEKT Premium Disposable Hypodermic Needle. The information provided is for a traditional medical device (hypodermic needle) and not an AI/ML powered device. Therefore, many of the requested categories in your prompt relating to AI/ML studies (e.g., sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.

Here's an attempt to answer the applicable parts of your request based on the provided text, while labeling the non-applicable sections.

Acceptance Criteria and Device Performance for TSK STERIJEKT Premium Disposable Hypodermic Needle

1. Table of Acceptance Criteria and 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)

• Sample Size for Test Set: Not specified in the provided 510(k) summary. The summary only lists the tests performed and their outcomes ("Meets Specification" or "Pass").
• Data Provenance: Not specified in the provided 510(k) summary. The manufacturer is "Tochigi Seiko KK, Japan." It is implied the tests were conducted by or on behalf of the manufacturer, but specific details about the origin (e.g., country) of the data from these tests are not provided. The study type (retrospective/prospective) is not applicable or specified for these types of device performance tests.

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)

• Not applicable for this type of medical device. Ground truth, in the context of AI/ML, refers to a definitively correct answer established by experts. For a hypodermic needle, "ground truth" is determined by established physical, chemical, and biological testing standards and specifications, not expert consensus on interpretations. The "experts" would be the scientists and engineers conducting and analyzing these standard tests.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve disagreements among human readers when establishing ground truth. For the physical and biological tests of a hypodermic needle, the outcome is typically an objective pass/fail against a predefined specification, not a subjective interpretation 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 device is a hypodermic needle, not an AI/ML diagnostic or assistive tool. An MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.

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

• Not applicable. This device is a hypodermic needle, not an algorithm. Standalone performance refers to an AI algorithm's performance without human intervention.

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

• Standardized Test Specifications/Reference Methods: For physical tests (Protector Removal, Needle Bond Strength), the "ground truth" is defined by adherence to engineering specifications and performance limits. For biological tests (Sensitization, Intracutaneous, Hemolysis, Systemic Toxicity, LAL Pyrogen Test, Cytotoxicity), the "ground truth" is determined by meeting the requirements of established biocompatibility and sterility standards (e.g., ISO 10993 series and pharmacopeial standards), which dictate acceptable biological responses.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. This is not an AI/ML device, so there is no "training set" and thus no ground truth established for one.

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