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The Savisafe Safety Device is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

The proposed device, Savisafe Safety Device is a non-sterile, single use anti-needlestick accessory for pre-filled ISO standard glass syringe that are 1ml with a needle length of 1/2". The proposed device consists of four components:(1) Syringe sleeve, (2) Syringe holder, (3) Plunger rod. (4) Spring. The proposed device has a five-year shelf life.

Here's a breakdown of the acceptance criteria and study information for the Savisafe Safety Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria for many of the tests. Instead, it states that the device "complies with the requirements" or that "the proposed device is substantial equivalence with the predicate device." Where specific findings are reported, they are included.

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

The document does not explicitly state the specific sample sizes used for each individual non-clinical performance test. It mentions that tests were conducted "both on the proposed device and the predicate device" for the Safety Feature Performance tests.

The provenance of the data is not specified (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) submission from a Chinese company, the testing was likely conducted in accordance with international standards, but the specific location of the test labs is not provided. All studies mentioned are non-clinical (laboratory/simulated), so "retrospective or prospective" doesn't strictly apply in the clinical sense.

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

This information is not applicable and not provided in the document. The studies conducted are non-clinical performance tests (biocompatibility, mechanical performance, simulated clinical use), not studies involving expert interpretation of medical images or clinical outcomes. Therefore, there's no "ground truth" established by medical experts in the traditional sense for these types of device performance tests.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers or reviewers are making interpretations (e.g., of medical images) and their disagreements need to be resolved to establish a ground truth. The tests described are objective, non-clinical performance evaluations.

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:

This is not applicable as the device is a medical accessory (safety device for syringes), not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI in the document, nor are human readers involved in the performance evaluation described.

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

This is not applicable since the device is a mechanical safety accessory, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, the "ground truth" is defined by adherence to established test standards and design specifications. For example:

• Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as determined by the specified ISO standards.
• Safety Feature Performance: The ability to activate and prevent override as per ISO 23908:2011 and deemed "substantially equivalent" to the predicate device.
• Simulated Clinical Study: Compliance with the requirements of FDA Guidance "Medical Devices with Sharps Injury Prevention Features."

This isn't "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather objective measurement against predefined engineering and biocompatibility criteria.

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" as this device is a mechanical safety accessory and does not involve machine learning or AI that would require training data.

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

This is not applicable since there is no training set.

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Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is (not) included. lt is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

This document describes the acceptance criteria and study proving the device meets those criteria for the Shina Syringe and Shina Safety Syringe.

The listed information primarily focuses on bench testing for mechanical, physical, and biocompatibility properties, rather than effectiveness studies involving human subjects or AI-assisted diagnoses. Therefore, several requested sections, particularly those related to clinical studies, human readers, ground truth establishment for training sets, and effect sizes of AI assistance, are not applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various ISO standards and USP . The document does not explicitly present specific numerical results for each test item but states that the tests demonstrated that the device performs in a substantially equivalent manner to the predicate device and meets the requirements.

Syringe

Needle

Syringe with needle (Model : WNLS0125)

Syringe with needle (Particulate test for various models including WNLG0123, WNLS0123, WNSG0125, WNLS0125, WNLG0323, WNLS0323, WNSG0325, WNLS0325, WNLG0523, WNLS0523, WNSG0525, WNLS0525, WNLG1023, WNLS1023, WNSG1025, WNLS1025)

Safety test

Biocompatibility (for 25G Model, 23G Model, and Syringe Model SSN2301)

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

The document does not explicitly state the sample size for each bench test conducted. The provenance of the data is that these are bench tests conducted by the manufacturer, Shina Med Corporation, in the Republic of Korea. The studies are by nature retrospective in the context of device development, where the device is manufactured and then tested to established standards.

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

This section is not applicable. The ground truth for these types of mechanical, physical, and biocompatibility tests is established by published international standards (ISO, USP, ASTM), not by expert consensus in diagnostic interpretation.

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

This section is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. The reported studies are bench tests against defined international standards.

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

This section is not applicable. No MRMC comparative effectiveness study was performed or discussed, as the device is a syringe and needle, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a physical medical device (syringe and needle) and does not involve an algorithm or AI.

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

The ground truth used for these tests are established international and national standards for medical devices, specifically:

• ISO 7886-1: Sterile hypodermic syringes for single use
• ISO 7864: Sterile hypodermic needles for single use
• ISO 9626: Stainless steel needle tubing
• USP : Particulate Matter in Injections
• ISO 23908: Sharps injury protection
• ISO 10993 series for Biological evaluation of medical devices (Parts 4, 5, 7, 10, 11, 23)
• ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials

8. The sample size for the training set

This section is not applicable. As this is a physical medical device submission focusing on bench testing, there is no AI model or "training set" in the context of machine learning.

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

This section is not applicable for the same reasons as section 8.

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The Medline Safety Insulin Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Medline TB (Tuberculin) Syringe is intended for the delivery of tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Medline Safety Insulin Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for delivery of U-100 Insulin. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver insulin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense insulin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The Medline Safety Insulin Syringe barrel contains major and minor graduated ink markings and will be available in a 1 ml (100 units), and 0.5 ml (50 units) syringe volumes with three different needle gauge sizes.

The Medline TB Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for Tuberculin use. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver tuberculin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense tuberculin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The syringe barrel contains graduated markings, with major graduation markings every 0.05mL and minor graduation markings every 0.01mL. The Medline TB Syringe will be available in a 1 mL syringe volume with three different needle sizes.

This document, a 510(k) premarket notification, describes the "Medline Safety Insulin and TB Syringes" and aims to demonstrate their substantial equivalence to a predicate device, the "Kendall Monoject® Magellan Insulin and Tuberculin Safety Syringe." It is not a document describing an AI/ML powered device, therefore the information requested in the prompt relating to AI models and ground truth generation (training set, test set, expert adjudication, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The acceptance criteria and study proving the device meets them relate to the physical and biological performance of the syringes, particularly their safety features and material compatibility.

Here's a breakdown of the acceptance criteria and performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of quantitative acceptance criteria alongside specific numerical performance results. Instead, it lists the types of non-clinical tests conducted and states that "The results of these tests have demonstrated the overall safety of the proposed device and its effectiveness in accordance with relevant test methods, and ultimately support a substantial equivalence determination." This implies that the device met the standards and requirements of the cited ISO, ASTM, and USP standards.

The categories of testing and implied performance goals are:

• Residuals: EO and Ethylene Chlorohydrin (ECH) residuals within acceptable limits per ISO 10993-7:2008(R)2012.
• Shelf Life: Maintain functionality and sterility for 5 years as demonstrated by accelerated aging studies per ASTM F1980-16.
• Transportation Testing: Device integrity maintained after simulated transport (ISTA-3A:2008 – drop, vibration with top load, vibration without top load, second drop test).
• Package Integrity: No dye penetration after distribution stimulation per ASTM F1929:2015. |
  | Chemical Safety Testing | - Particulate Matter: Meet requirements of USP for particulate matter in injections.
• Phthalates: Acceptable levels of phthalates.
• Bacterial Endotoxin: Meet requirements of USP and Limulus Amebocyte Lysate (LAL) testing for bacterial endotoxins. |
  | Functional Performance Testing | - Visual Appearance: Pass visual inspection per ASTM F1886:2016 for seal integrity.
• Package Integrity: Pass seal leak detection per ASTM F1929-15.
• Seal Strength: Meet strength requirements per ASTM F88-21.
• Syringe Performance (Insulin): Meet requirements of ISO 8537:2016 for sterile single-use syringes for insulin.
• Sharps Injury Protection: Meet requirements and test methods of ISO 23908:2011 for sharps protection features.
• Needle Requirements: Meet requirements of ISO 7864:2016 for sterile hypodermic needles for single use.
• Needle Tubing: Meet requirements of ISO 9626:2016 for stainless steel needle tubing.
• Manual Syringe Use: Meet requirements of ISO 7886-1:2017 for sterile hypodermic syringes for manual use. |
  | Usability Testing | - Demonstrate effective sharps injury prevention features in simulated clinical use, in accordance with FDA guidance "Medical Devices with Sharps Injury Prevention Features." |
  | Biocompatibility Testing | - Cytotoxicity: No in vitro cytotoxicity (ISO 10993-5:2009).
• Sensitization: No sensitization (ISO 10993-10:2010).
• Irritation: No irritation (ISO 10993-10:2010).
• Acute Systemic Toxicity: No acute systemic toxicity (ISO 10993-11:2017).
• Hemolysis: Acceptable hemolytic properties (ASTM F756-17, ISO 10993-4:2017).
• Material-Mediated Pyrogenicity: No pyrogenic response (USP , ISO 10993-11:2017).
• Subacute/Subchronic Toxicity: No subacute/subchronic toxicity (ISO 10993-11:2017).
• Complement Activation: Acceptable complement activation (ISO 10993-4:2017).
• Partial Thromboplastin Time: Acceptable effect on PTT (ISO 10993-4:2017).
• Platelet and Leukocyte Counts: Acceptable effect on platelet and leukocyte counts (ISO 10993-4:2017). |

2. Sample Size for Test Set and Data Provenance

The document does not specify exact sample sizes for each test. Instead, it refers to industry standards (ISO, ASTM, USP) which typically prescribe minimum sample sizes for specific tests. The provenance of the data is not explicitly stated in terms of country or retrospective/prospective, but these are standard non-clinical laboratory tests performed on manufactured devices.

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

This is not applicable to this type of device submission. The "ground truth" for these tests are the established parameters and performance requirements defined by the international and national standards (ISO, ASTM, USP). The "experts" would be the qualified personnel performing the testing in compliance with these validated methods.

4. Adjudication Method for the Test Set

Not applicable. Testing results are generally objective measurements against established pass/fail criteria from the standards.

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

Not applicable. This device is a mechanical syringe, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a mechanical syringe.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• International and National Standards: ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), and USP (United States Pharmacopeia) define the performance and safety requirements.
• Predicate Device Equivalence: The primary objective is to demonstrate that the new device performs as safely and effectively as the legally marketed predicate device (Kendall Monoject® Magellan Insulin and Tuberculin Safety Syringe).
• Biocompatibility Standards: Guidelines from ANSI/AAMI/ISO 10993-1 ensure the materials are safe for biological contact.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.

The provided text is a 510(k) summary for a medical device (Monoject Magellan Insulin Safety Syringe). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not contain any information about an AI/ML-driven device or its acceptance criteria and study results. The device described is a physical medical device (syringe), not a software or AI/ML product.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated study results for an AI/ML device based on the provided text. The questions posed (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set data) are relevant to the evaluation of AI/ML models, but the provided document is not about such a device.

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The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration of fluids. Phlebotomy is not an intended use of this device.

The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intraperitoneal are not intended uses of this device.

The needle system contains an internal mechanism that retracts the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidenticks during normal handling and disposal.

The PowerPAK™ syringe is single-use, non-reusable, sterile safety syringe containing a 22GA needle with a usable needle length of 1.80 inches and a syringe capacity of 3mL. The PowerPAK™ Syringe is indicated for general medical use by healthcare providers in the aspiration and injection of fluids via subcutaneous, intradermal, and intramuscular routes of administration. Phlebotomy and intravenous use are not an intended use of this device.

The PowerPAK™ syringe is a 3mL safety syringe with a permanently attached needle system containing an internal mechanism that retracts the needle inside the plunger rod of the syringe to prevent reuse of the syringe and accidental needle sticks during normal handling and disposal. Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates needle retraction. Propellant is the same medical grade propellant currently used in legally marketed dose inhalers.

The subject device is a single use, non-reusable, sterile safety syringe comprised of three main components including a Plunger, Syringe body, and Needle System.

I am sorry, but the provided text describes an FDA 510(k) clearance letter for a medical device called the "PowerPAK Syringe." This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing against various ISO standards and FDA guidance documents.

The document does not contain information about:

1. Acceptance criteria and reported device performance in a table format for qualitative measures. The listed tests are primarily pass/fail against standards for physical properties, materials, and sterilization, not typical subjective performance metrics (like accuracy, precision, sensitivity, specificity, or image quality) that would require an acceptance criteria table.
2. Sample size used for a "test set" in the context of an AI/ML study. The tests mentioned are for device performance, biocompatibility, and sterilization, where sample sizes are typically specified by the relevant ISO standards.
3. Data provenance (country of origin, retrospective/prospective) related to AI/ML model training or testing.
4. Number of experts used or their qualifications for establishing ground truth.
5. Adjudication method for a test set.
6. Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human-in-the-loop performance improvement.
7. Standalone (algorithm-only) performance.
8. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
9. Sample size for a training set (AI/ML).
10. How ground truth for a training set was established (AI/ML).

The document primarily focuses on the device's physical and functional characteristics, safety features (needle retraction), biocompatibility, and sterilization, and its comparison to a similar predicate device. It confirms that the device meets existing performance standards for syringes and sharps injury prevention.

Therefore, I cannot provide the requested information as it is not present in the given text.

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SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling. SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand. Its intended condition is sterile, single use, for hospital or home use.

The furnished text is a 510(k) summary for the SafeR Syringe and SafeR Sting, a medical device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for a new AI/Machine Learning diagnostic device. Therefore, a direct answer to your request for acceptance criteria and study data proving the device meets acceptance criteria for an AI/ML device cannot be fully extracted from this document.

However, I can extract the acceptance criteria related to the performance of this specific medical device (a syringe and needle) and how it was proven to meet these.

Here's an analysis based on the provided text, reinterpreting your request in the context of this device:

Acceptance Criteria and Device Performance (based on Non-Clinical Performance Testing):

The "acceptance criteria" for this device are defined by its conformity to various international ISO standards for syringes, needles, and safety features. The core of the performance testing is to demonstrate that the SafeR Syringe and SafeR Sting meet these established standards, thus proving its safety and effectiveness relative to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical thresholds and exact measured performance values for each. Instead, it refers to compliance with established industry standards. The "Reported Device Performance" is consistently stated as "Conformity to [ISO Standard]" or "Meets requirements."

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

The document does not explicitly state the sample sizes used for each specific non-clinical test. It generally refers to "Performance tests (bench)" and "test results." The provenance of the data is not mentioned in terms of country of origin or whether it was retrospective or prospective, as these terms are more relevant for clinical studies than bench testing of a physical device. All tests appear to be conducted in a laboratory/bench setting.

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

Not applicable. The "ground truth" for the performance of a physical medical device (syringe and needle) is established through objective, quantifiable measurements against engineering specifications and international standards (e.g., ISO, ASTM), rather than expert consensus on subjective interpretations (as would be the case for AI/ML diagnostic imaging).

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for studies where human expert disagreement needs to be resolved (e.g., in medical image interpretation for AI ground truth). For bench testing of a physical product against standards, the measurements are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No. This type of study is specifically designed to evaluate the performance of diagnostic systems (often AI-assisted) where human readers interpret cases. The SafeR Syringe and SafeR Sting is a physical medical device, not a diagnostic imaging AI/ML product.

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

Not applicable. This device is a physical product, not an algorithm. Its performance is inherent in its design and manufacturing, tested through objective bench testing.

7. The Type of Ground Truth Used:

The ground truth is based on objective measurements against established engineering specifications and international standards (ISO, ASTM). For example, for "Lubricant amount," the ground truth is "

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The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.

The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.

The provided document, a 510(k) Premarket Notification summary for Disposable Automatically Retractable Safety Syringes, does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in the manner typically found for AI/ML-based medical devices. This document specifically pertains to a physical medical device (syringes) and not an AI/ML diagnostic or therapeutic system.

Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence of a new syringe design to a predicate device based on non-clinical testing of physical and chemical properties and a simulated clinical study for sharps injury prevention.

Here's an interpretation of the closest relevant sections to your request formats, acknowledging the fundamental difference in device type:

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

The document lists "Non-Clinical Tests performed on the subject device" and references various ISO standards for syringe and needle properties. These standards implicitly define the acceptance criteria, and the statement "The proposed devices were tested per the following standards, to evaluate its performance" implies that the device met these standards. However, the document does not report specific quantitative performance data or explicit acceptance thresholds met by the device for each test. It only lists the tests performed.

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

• Sample Size for Test Set: Not explicitly stated, but the "Simulated Clinical Study Summary" mentions a study "conducted as recommended in FDA guidance document for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features." While the exact number of devices tested is not provided, the claim of "99% reliability of device activation is achievable" implies a statistically significant sample was used to arrive at this figure.
• Data Provenance: Not explicitly stated for specific test data, but the manufacturer is "Shantou Wealy Medical Instrument CO.,Ltd." located in Guangdong, China. The testing was conducted to international ISO standards.

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

• Not Applicable. This is a physical device; "ground truth" as it applies to AI/ML diagnostic or annotation data is not relevant here. Performance is measured against physical standards and functional requirements.

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

• Not Applicable. This is a physical device. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic imaging or clinical assessments, usually involving multiple human readers. Here, performance is based on objective lab measurements and functional tests.

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 physical device and involves no human "readers" or AI assistance. The "Simulated Clinical Study" refers to evaluating the sharps injury prevention feature, not an AI-assisted diagnostic task.

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

• Not Applicable. This is a physical device. There is no algorithm to run in a standalone fashion.

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

• Not Applicable. For this physical device, "ground truth" is established by the specifications of the relevant ISO standards (e.g., a certain force must be applied, there should be no leakage, specific dimensions are met, activation must occur). The "99% reliability of device activation" from the simulated clinical study would be considered a performance outcome, not a "ground truth" in the AI/ML sense.

8. The sample size for the training set:

• Not Applicable. This is a physical device; there is no AI/ML training set.

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

• Not Applicable. This is a physical device; there is no AI/ML training set or associated ground truth.

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The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.

Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

The provided document describes the 510(k) premarket notification for "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle" (K221247) by Jiangsu Kangbao Medical Equipment Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K170651) based on non-clinical testing.

Here's a breakdown of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various international and ASTM standards that the device was tested against. The acceptance criterion for each standard is implicit within the standard itself (e.g., "complies with the requirements of related standards," "no cytotoxicity," "no hemolysis"). The reported performance consistently states that the proposed device met these criteria.

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

The document does not specify the exact sample sizes for each non-clinical test performed on the test set. It mentions "non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device." Similarly, for biocompatibility and packaging tests, it states "The proposed device was evaluated for the following tests" and "Sterile barrier packaging testing were performed on the proposed device."

The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Jiangsu Kangbao Medical Equipment Co., Ltd. from China. The studies are non-clinical, meaning they are lab-based and not involving human subjects. They are inherently prospective in nature as they test the new device against established standards.

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

This information is not applicable to this submission. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP). These standards define the test methods and acceptance criteria, and the device's performance is measured against these objective criteria rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the tests are against objective engineering and biological standards, there is no need for an adjudication method typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on non-clinical performance, biocompatibility, and substantial equivalence to a predicate device based on these non-clinical tests. Therefore, there is no effect size reported for human readers with or without AI assistance.

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

This question is not applicable as the device is a physical medical instrument (syringe and needle), not an algorithm or AI-powered system. No standalone "algorithm only" performance was evaluated.

7. The type of ground truth used:

The type of "ground truth" used for this submission is based on established international and national standards and their defined acceptance criteria. For example:

• Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, complement activation, and thrombogenicity as defined by the respective ISO and USP standards.
• Physical/Mechanical/Chemical Performance: Compliance with the specifications and performance requirements outlined in ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, and USP .
• Packaging Integrity: Maintenance of sterility barrier as per ASTM F1886/F1886M-16, ASTM F88/F88M-15, and ASTM F1929-15.
• Sterilization: EO/ECH residue within limits (ISO 10993-7), endotoxin limit (USP ), and sterile assurance level (SAL) of 10-6.
• Safety Feature: Meeting pre-established criteria as per FDA Guidance and ISO 23908:2011.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" to establish.

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

This information is not applicable as there is no training set for this type of device.

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The Auto-disable Syringe for Fixed-dose Immunization is intended for use in the aspiration and injection of fluids for medical purpose.

Not Found

Based on the provided FDA 510(k) letter, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria for the following reasons:

• Device Type: The document is a 510(k) clearance letter for an Auto-disable Syringe for Fixed-dose Immunization, which is a physical medical device (piston syringe), not a software or AI-based device.
• Study Type: For physical medical devices like syringes, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" typically refer to performance testing (e.g., plunger force, leakage, dose accuracy under various conditions, sterility, material biocompatibility, auto-disable mechanism function) rather than studies involving expert readers, ground truth establishment, or AI algorithm performance metrics (sensitivity, specificity, AUC).
• Lack of Performance Data: The provided text is an official FDA clearance letter, which confirms substantial equivalence to a predicate device and outlines regulatory obligations. It does not contain the detailed performance study results, acceptance criteria, sample sizes, or ground truth methodologies that would be submitted within the 510(k) application itself. These details are part of the technical documentation reviewed by the FDA but are not typically included in the public clearance letter.

Therefore, the requested information, which pertains to AI/software performance evaluation (e.g., MRMC studies, standalone algorithm performance, expert ground truth, training/test set details), is not applicable to the device described in this specific FDA document. The document describes a physical medical device, not an AI or imaging diagnostic software.

To answer your question, one would need to see the actual performance data and study reports submitted as part of the 510(k) application for a software device, not this physical syringe.

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The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

The provided text describes the regulatory clearance (510(k)) for the "Sterile Hypodermic Syringes for Single Use with Safety Needles" by Sichuan Prius Biotechnology Co., Ltd. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report for AI-powered medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or present in this given text.

However, I can extract the acceptance criteria and performance data for the non-clinical functional and safety aspects of the device, as well as general information about testing methodologies.

1. Table of acceptance criteria and the reported device performance:

The following questions are not applicable as the document describes a traditional medical device (syringes with safety needles) and not an AI/ML-powered device:

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is for physical characteristics and biological safety, not a "test set" in the AI/ML context.
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. This refers to expert review for AI/ML model training/validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI context. For physical device testing, "ground truth" is established by the specified ISO/ASTM standards and their associated test methods for measuring properties (e.g., strength, sterility, dimensions).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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