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The HWJECT Auto-Disable Syringe is intended for aspiration of fluids. Additionally, it features autodisable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.

The auto-disable syringe is intended for aspiration and injection of fluids. The subject device is composed of needle cap, barrel, plunger, clip, plunger stopper, and needle tube. The clip cooperates with plunger and barrel to complete self-destruction of the device. It is nonpyrogenic and intended for single use. The auto-disable feature (no sharp injury) involves a design where the syringe automatically becomes inoperable by locking the plunger with the clip after injection to prevent syringe reuse. The capacity of the auto-disable syringe is available in 0.05 mL, 0.1 mL, 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube ranges from 22G to 27G. The needle length ranges from 10 mm to 38 mm.

This document is a 510(k) premarket notification for a medical device called the "HWJECT Auto-disable syringe." The FDA's review concludes that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence to an existing device, rather than proving a novel device's safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the study conducted is primarily non-clinical performance testing and biocompatibility testing, aiming to show that the new device performs comparably to the predicate device and meets established safety standards. There is no information about AI/ML models or human reader studies in this document. The term "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to demonstrate substantial equivalence, not statistical measures for an AI model's performance.

Here's an analysis based on the provided text, while explicitly noting that the request for information on AI/ML-specific criteria (like MRMC studies, expert adjudication for ground truth of an AI model, and training/test set sample sizes for AI) is not applicable to this document as it does not describe an AI/ML medical device.

Acceptance Criteria and Device Performance for HWJECT Auto-disable syringe

The acceptance criteria for this device are largely defined by adherence to recognized international and national standards for medical devices, particularly those for hypodermic syringes and needles. The "study" refers to a series of non-clinical tests performed to demonstrate compliance with these standards and substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Limits for extractable metals
• Lubricant
• Tolerance on nominal capacity
• Graduated scale
• Barrel
• Design
• Fit of the plunger stopper/plunger in the barrel
• Fiducial line
• Dead space
• Freedom from air and liquid leakage
• Auto-disable syringe feature | Performance testing results met the requirements of the standard, demonstrating substantial equivalence to the predicate device. Specific numerical results are not provided in this summary, but the conclusion is conformance. For the auto-disable feature, "Activation force: 2-4 N," and "Auto-disabled, prevents syringe re-use" are explicitly stated as characteristics matching the predicate device. |
  | ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods) | - Stiffness
• Resistance to breakage
• Resistance to corrosion
• Needle O.D.
• Needle inner diameter | Performance testing results met the requirements of the standard. For the 22G needle gauge (a difference from the predicate), specific testing was conducted to verify that this difference does not raise new questions of safety and effectiveness, and it was found to be "in accordance with ISO 9626." |
  | ISO 7864:2016 (Sterile hypodermic needles for single use-Requirements and test methods) | - Needle point
• Bond between hub and needle tube
• Patency of lumen
• Cleanliness
• Needle length
• Testing for measuring the penetration force and drag force for needles | Performance testing results met the requirements of the standard. For needle bonding strength, a range of "62-100 N" is reported, conforming to ISO 7864:2016 requirements. For differences in needle length (extra specifications compared to predicate), non-clinical performance testing validated that these do not raise new safety/effectiveness questions. |
  | USP (Particulate matter in injections) | USP acceptance criteria for particulate matter. | Particulate testing results met the USP acceptance criteria. |
  | Biocompatibility Testing | Compliance with ISO 10993-1 for an Externally Communicating Device, Blood Path Indirect, Limited Contact (

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The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the plunger can be locked for self-locking.

The provided text describes a 510(k) premarket notification for a medical device: Sterile Auto-Disable Syringes with/without Needle for Single Use. The FDA clearance letter indicates that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Safety Auto-Disable Syringe with Needle (Auto-Lock), K143497).

However, the provided document does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device. The document is a regulatory submission for a physical medical device (syringes) and details its physical, material, and performance characteristics compared to a predicate device.

Specifically, the document discusses:

• Device Description: The physical components and mechanism of the auto-disable syringe.
• Indications for Use: Aspiration of fluids and fluid injections.
• Comparison to Predicate Device: Detailed table comparing features like indications for use, product code, regulation number, class, principle of operation, safety features, intended user, environment of use, syringe volume, nozzle type, lubricant, barrel transparency, graduations legibility, needle length, needle gauge, configuration of the tip, needle hub, single use, performance specifications, sterilization, SAL, materials, pyrogenicity, biocompatibility, and labeling.
• Performance Data: Lists various tests conducted to demonstrate the physical device's safety and bio-compatibility, such as biocompatibility testing (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogens, Hemolysis, Particulate Matter), sterilization validation, shipping and shelf-life testing, and performance testing against ISO standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-4, ISO 7886-1).

None of the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device is present in this documentation. The questions about sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment are relevant to AI/ML device evaluations, but not to the type of device described in this 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance and validation using the provided text. The document is about the substantial equivalence of a physical syringe, not a software or AI/ML product.

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The Sol-Guard Auto-Disable Syringe is intended for aspiration and injection of fluids into the body. In addition, the Sol-Guard™ Auto-Disable Syringe is designed to prevent syringe and needle reuse.

The SOL-GUARD Auto-Disable syringe is a sterile, single-use, 3-part hypodermic syringe with an auto-disable feature that is intended to deliver a fixed dose of medicine/vaccine immediately after filling. The SOL-GUARD Auto-Disable syringe has a fixed needle and plunger rod with affixed metal clip which is designed for the prevention of the syringe and needle re-use by automatically activating the clip and locking the plunger after injection. The syringe is individually blister packaged, and EtO sterilized with SAL of 106. This syringe is intended for aspiration and injection of fluids.

This document is an FDA 510(k) summary for a medical device (Sol-Guard Auto-Disable Syringe). It does not describe an AI medical device or a study involving AI, nor does it use terms like "acceptance criteria," "test set," "ground truth," "MRMC," or "standalone performance" in the context of AI algorithm validation.

Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device meets acceptance criteria for an AI device from this document. The document describes the non-clinical (bench) testing performed for a mechanical syringe to demonstrate its substantial equivalence to a predicate device, with a focus on the new auto-disable feature.

If you are looking for information about the validation of an AI medical device, you would need a different type of document, typically a clinical study report or a 510(k) summary for an AI/ML-enabled 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 Safety Syringe with Needle for Single Use 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 Safety Hypodermic Needle for Single Use 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 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 Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes.

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

The provided text describes a 510(k) summary for Sterile Safety Syringes and Needles. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a multi-reader multi-case (MRMC) study.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment for AI/ML device validation are not present in this document, as this is a traditional medical device submission.

However, I can extract information related to the non-clinical performance tests that serve as acceptance criteria for this type of device and how the device proved it met them.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this non-AI/ML device are primarily based on compliance with established international standards and demonstration of substantial equivalence to predicate devices through various non-clinical tests. The reported device performance is presented as meeting these standards and showing similar performance to predicates.

Additional Details (Based on available information and the nature of this submission):

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

   • The document does not specify exact sample sizes for each non-clinical test performed (e.g., how many syringes were tested for each performance characteristic, or how many samples for biocompatibility).
   • The data provenance is implied to be from non-clinical testing conducted by the manufacturer, Shandong Weigao Group Medical Polymer Co., Ltd. (China). These are laboratory tests, not human data. The document does not specify if the tests were performed retrospectively or prospectively relative to the submission date, but typical device testing for 510(k) is performed as part of the development and validation process.

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

   • N/A. This is a submission for a traditional medical device (syringes and needles), not an AI/ML device that requires human expert review to establish "ground truth" for interpretive tasks (like image classification). The "ground truth" for this device's performance is established by objective measurements and compliance with international standards in laboratory settings.

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

   • N/A. This concept applies to human reader studies often conducted for AI/ML devices where there might be disagreement among readers. For physical device testing, adjudication methods generally involve standardized measurement protocols and calibration, not expert consensus.

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. This is not an AI/ML device, so an MRMC study is not applicable or mentioned.

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

   • N/A. This is not an AI/ML device. The "standalone" performance here refers to the device itself meeting the defined physical and performance criteria.

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

   • The "ground truth" for this device's performance is based on objective, measurable criteria as defined by international standards (e.g., ISO, ASTM). For example:
     • Needle sharpness and bend resistance are measured via mechanical tests.
     • Syringe flow rates and accuracy are measured via fluid dynamics tests.
     • Biocompatibility is assessed through standardized biological assays.
     • Sterility is validated through microbiological testing (SAL).
     • Safety mechanism effectiveness is assessed via simulated use tests following FDA guidance and ISO standards.

8. The sample size for the training set:

   • N/A. This is a manufactured physical device, not an AI/ML algorithm that requires a "training set."

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

   • N/A. Not applicable.

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The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

The provided document is a 510(k) summary for a medical device (Sterile Auto-Disable Syringes with/without Needle for Single Use). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, the document does not contain the specific details about acceptance criteria and the comprehensive study results to prove that the device meets those criteria, as requested in your prompt regarding a typical device performance study.

The prompt asks for details like:

1. A table of acceptance criteria and the reported device performance: This is not provided in a summarized table format for specific performance metrics.
2. Sample sizes used for the test set and the data provenance: Not specified for each test.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable as this is a physical medical device, not an AI/diagnostic software.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance: The document describes performance testing for the device itself (standalone in a physical sense), but not algorithm standalone performance.
7. Type of ground truth used: For physical device testing, ground truth refers to established standard measurements and specifications (e.g., ISO standards).
8. Sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding performance and testing:

The Section "VII Performance Testing" lists the types of tests conducted:

• Biocompatibility testing:
  • Classification: Externally Communicating Device, Blood Path Indirect, Limited Contact (.
  • Acceptance Criteria/Reported Performance: It states "Conforms to ISO 10993" and "Non-pyrogenic" but does not provide specific numerical outcomes or detailed acceptance criteria for each sub-test.
• Sterilization, Shipping and shelf-life:
  • Tests conducted: EO sterilization validation per ISO11135:2014, Pyrogen testing per USP , EO residuals per ISO 10993-7, Simulated shipping per ASTM D4169, Sterile Barrier Package testing (Seal Strength ASTM F88/F88M-2015, Bubble leak testing ASTM D3078-02(2013), Dye Penetration ASTM F1929-2015).
  • Acceptance Criteria/Reported Performance: "Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16." It implies compliance with these standards, but doesn't offer specific data points or "acceptance criteria met" statements for each.
• Performance testing:
  • Tests conducted according to: ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2016, ISO 7886-4:2018, ISO 7886-1:2017.
  • Acceptance Criteria/Reported Performance: The comparison table (Table 5-1) under "Performance specifications" states: "Complies with ISO 7864, ISO 7886-1, ISO 7886-4." This indicates the device passed these standards, which inherently include acceptance criteria for parameters like syringe dimensions, fluid leakage, plunger force, auto-disable features, etc. However, the exact specific criteria and the numerical results are not detailed in this summary.

In summary, based only on the provided text, I cannot construct the detailed table and answer all points of your prompt because the 510(k) summary provides a high-level overview of the types of tests performed and the standards met, rather than detailed acceptance criteria and specific reported performance metrics for each test. The document confirms that testing was done to demonstrate compliance with relevant international standards, which is typical for a 510(k) submission showing substantial equivalence for a physical device.

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The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

The provided text describes a 510(k) premarket notification for a medical device called "Sterile Auto-Disable Syringes with/without Needle for Single Use." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. The information details the device, its intended use, and a comparison to the predicate, along with performance testing conducted.

Here's an analysis of the provided text in relation to your request for acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" with numerical targets in a tabular format as you might expect for a specific performance metric (e.g., "accuracy > 90%"). Instead, it states that the device's performance "complies with" or "conforms to" various ISO standards. For medical devices like syringes, these standards themselves define the performance requirements and test methods. Therefore, the "acceptance criteria" are implicitly the requirements set forth by these international standards, and the "reported device performance" is that the device meets those standards.

Below is a table constructed from the "Performance testing" section, indicating the relevant standards as acceptance criteria and the reported performance as compliance with these standards.

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

The document does not specify the sample size used for any of the performance tests.
The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). These details are typically found in the full test reports, which are summarized here.

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

This information is not applicable to this type of device and study. The testing for a syringe involves physical, chemical, and biological performance against standardized criteria, not interpretation by human experts to establish a "ground truth" like in imaging or diagnostic studies. The "ground truth" is defined by the parameters and thresholds in the ISO and ASTM standards themselves.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth for subjective assessments. Since this study relies on objective performance against defined standards, there's no need for 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

This is not applicable. An MRMC study is relevant for diagnostic or AI-assisted interpretation devices. This submission concerns sterile auto-disable syringes, which are physical medical devices, not diagnostic software.

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

This is not applicable. This is not an algorithmic device.

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

The "ground truth" for the performance of the syringe device is defined by the requirements and test methods specified in the cited international ISO and ASTM standards. For example, for "Seal Strength," the ISO/ASTM standard dictates the method and acceptable range, which serves as the objective ground truth. For "Biocompatibility," the ground truth is whether the device materials elicit a toxic response beyond defined limits, as determined by standardized biological tests.

8. The sample size for the training set

This is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

This is not applicable for the reason stated above.

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The AUTO DISABLE SYRINGE is intended for use in the suction of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.

The AUTO DISABLE SYRINGE is designed for the hypodermic injection of the intended micro scale solution. It has the automatic function in the structure of the syringe which after injection of an intended fixed dose locks the syringe to prevent re-use of the syringe. It can be widely used for injection of vaccine for the immunization.
The syringe consists of a calibrated hollow barrel, a movable plunger, a rubber stopper (piston) assembled at end of the plunger, and a steel clip installed between the barrel and the plunger that functions to prevent re-use of the syringe.
At the end of the barrel, a fixed an unmovable needle is installed, and a needle cap covers the needle. The zero line and nominal capacity line are printed outside of barrel. The main materials are PP, latex free (polyisoprene rubber) and stainless steel.

This document describes the regulatory approval for an "Auto Disable Syringe" (K210464). The acceptance criteria are essentially the compliance with various international standards, and the "study" that proves the device meets these criteria is a series of non-clinical, functional performance, sterility, shelf-life, and biocompatibility tests.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and 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 does not explicitly state the specific sample sizes for each test mentioned (e.g., how many syringes were tested for flow rate, or how many were used in biocompatibility studies). It broadly states that the "AUTO DISABLE SYRINGE described in this summary were tested".

Regarding data provenance:

• Country of Origin: The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. from Tianchang, Anhui, China. It is highly probable that the non-clinical testing was performed in China or by labs commissioned by the Chinese manufacturer.
• Retrospective or Prospective: The testing described (functional performance, sterility, shelf-life, biocompatibility) is typically prospective and conducted specifically for regulatory submission to demonstrate compliance with standards and safety/effectiveness of the device.

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 is a medical device (syringe), not an AI/diagnostic imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) does not apply. The "ground truth" for this device's performance is established by objective measurements against recognized international standards through laboratory testing.

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

Not applicable. As noted above, this device's performance is determined by objective physical, chemical, and biological tests against established standards, not by human interpretation that would require 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 physical medical device (syringe), not a diagnostic imaging device utilizing AI.

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

Not applicable. This is a physical medical device (syringe), not an algorithm or AI.

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

The "ground truth" for this device is established by objective measurements and pass/fail criteria defined by recognized international standards (e.g., ISO, ASTM, USP). For example:

• Functional performance: Measurements of flow rate, penetration force, bonding strength, tolerance on nominal capacity, etc., against predefined limits in standards like ISO 7864, ISO 7886, ISO 9626.
• Sterility: Demonstrated sterile assurance level (SAL) of 10-6 per ISO 11135.
• Biocompatibility: Absence of cytotoxic, sensitizing, irritating, systemic toxic, pyrogenic, or hemocompatible effects as determined by tests outlined in ISO 10993 series.
• Shelf-life: Maintenance of package integrity and device functionality over a specified period (5 years) as per ASTM F1980.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

Not applicable. As there is no training set for a physical medical device.

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The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.

The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe device is a sterile two-piece piston syringe designed to deliver a single fixed dose. It features a permanently attached hypodermic needle and auto-disable feature that prevents reuse of the syringe by locking the plunger rod in place after injection. The SoloShot™ Mini Syringe consists of a syringe barrel, a one-piece plunger rod (without rubber stopper), a clip affixed to the plunger rod and a integral needle is protected with a shield cover. The clip activates the auto-disabled feature, preventing re-use of the syringe is individually blister packaged and ETO sterilized to SAL of 10-6 .

The provided document is a 510(k) summary for the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe, which is a medical device. This type of document is used to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific performance criteria in a clinical setting in the way a diagnostic AI device might.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of device and submission. This is a syringe, and its performance is evaluated through bench testing, biocompatibility, and sterilization, not through clinical trials where human readers or AI algorithms analyze data for diagnostic purposes.

Here's an attempt to answer the questions based on the provided document, highlighting what is applicable and what isn't:

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

The document states that "In all instances, the BD SoloShot™ Mini Syringe functioned as intended and results observed met the predefined acceptance criteria." However, the exact numerical acceptance criteria for each test and the precise numerical results are not provided in this summary. The summary only lists the types of tests performed.

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

This information is not provided in the 510(k) summary. These tests are "bench performance" tests, not clinical studies involving patient data. The "sample size" would refer to the number of syringes tested for each performance characteristic, which is typically standard practice for device validation but not detailed here.

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 is not applicable to this type of device. "Ground truth" in the context of expert consensus is relevant for diagnostic devices that interpret images or other patient data. For a syringe, performance is measured against objective physical and chemical standards, not expert interpretation of patient-related data.

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

This is not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., by experts) to resolve disagreements. Here, the performance is measured objectively.

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. An MRMC study is relevant for diagnostic devices, particularly those involving human readers and AI assistance. This device is a syringe, not an AI diagnostic tool.

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

This is not applicable. This is a physical medical device (syringe), not an algorithm or AI system.

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

For this device, "ground truth" refers to established engineering, chemical, and biological standards (e.g., ISO standards for sterility, biocompatibility, and physical performance). The device's performance is measured against these objective standards.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a syringe's performance evaluation. Training sets are used in machine learning for AI algorithms.

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

This is not applicable. As there is no training set for a syringe, there is no ground truth to establish for it.

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