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TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip / lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only.

The provided text is a 510(k) summary for a medical device called "TK Sterile Piston Syringe without Needle." It outlines the device's characteristics and compares them to a legally marketed predicate device (U&U Sterile Piston Syringe without Needle) to establish substantial equivalence.

However, the provided document DOES NOT contain information about a study that uses an AI/ML algorithm or requires ground truth established by experts. It describes a conventional medical device (syringe) and its testing against established international standards for physical, chemical, and biological properties. Therefore, I cannot generate the requested table and study details related to acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of an AI/ML study.

The document focuses on demonstrating that the new syringe complies with performance standards through non-clinical performance testing (e.g., liquid leakage, air leakage, conical fitting integrity), sterility testing, and biocompatibility testing.

Here's what I can extract and present based on the provided text, reinterpreting "acceptance criteria" in the context of a non-AI/ML medical device's performance testing:

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

The device, "TK Sterile Piston Syringe without Needle," is a conventional medical device. Its acceptance criteria are based on compliance with established international standards for syringes, rather than AI/ML performance metrics. The study described focuses on demonstrating equivalence to these standards and to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML specific questions:

2. Sample sizes used for the test set and the data provenance: Not applicable. This document is for a physical medical device, not an AI/ML algorithm. Testing involves physical samples of syringes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a syringe's performance is established by objective physical, chemical, and biological measurements against established standards, not expert consensus on an AI's output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like those listed are used for human reader studies with AI, not for physical device testing.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" for performance is defined by the objective pass/fail criteria of the various ISO and USP standards referenced (e.g., specific thresholds for fluid leakage, absence of microbial growth, acceptable levels for extractable metals, absence of adverse biological reactions).
8. The sample size for the training set: Not applicable. This applies to AI/ML devices.
9. How the ground truth for the training set was established: Not applicable. This applies to AI/ML devices.

Conclusion stated by the submitter:

"The TK Sterile Piston Syringe without Needle is substantially equivalent to the U&U Sterile Piston Syringe without Needle. The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent."

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U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection.
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration.

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.

The provided document is a 510(k) summary for the U&U Sterile Piston Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.

Therefore, the information needed to directly answer many of the questions regarding acceptance criteria, specific study details, and performance metrics for the device itself is not present in this regulatory submission. This document highlights that the device conforms to existing standards but doesn't provide the detailed study results that would typically be associated with performance validation.

However, based on the information provided, here's what can be extracted and inferred:

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

The document states that the device "Conforms to ISO7886-1" for performances and "Conforms to ISO10993" for biocompatibility. These international standards provide the acceptance criteria for piston syringes and biocompatibility, respectively. The reported performance is that the device meets these standards. Detailed numerical results or specific pass/fail rates for individual tests within these standards are not provided in this summary.

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. The summary refers to the device "conforming" to standards, which implies testing was conducted, but details on sample size, test set design, or data provenance are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This device is a piston syringe, a physical medical instrument, not an AI or diagnostic system that requires expert interpretation for ground truth establishment. Its performance is evaluated against engineering and biological standards.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the primary mode of evaluation for a piston syringe's performance against ISO 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 information is not applicable and not provided. This device is a piston syringe and not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established by the technical specifications and test methods defined within the ISO7886-1 and ISO10993 standards. For example, for ISO 7886-1, "ground truth" would be objective measurements of force, leakage, volume accuracy, etc., against predefined limits. For ISO 10993, "ground truth" would be the results of specific biological tests (cytotoxicity, irritation, sensitization, etc.) against established safety thresholds.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided for the same reason as above.

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International Medsurg Connection's piston syringe is intended for the injection of fluids into, or withdraw of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. The intended use is the same as the intended use on IMC piston syringe sold by International Medsurg Connection, Reference K022159.

This submission includes piston syringe that will be sold both sterile and non-sterile syringes are to be sold to OEMs for EtO sterilization according to their validated process per ANSVAMMISO 11135. Sterile syringes are to be sold directly to users after EO sterilization validation per ANSVAMMI/ISO 11135

The device consists of a calibrated hollow barrel and a movable plunger with piston. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into or withdraw fluids from, the body.

The provided text describes a 510(k) submission for an IMC Piston Syringe and does not contain information about an AI/ML device. Therefore, it does not fit the typical structure of an acceptance criteria and study report for such a device. This document is a regulatory submission for a medical device (piston syringe) claiming substantial equivalence to a predicate device.

However, I can extract the relevant "performance data" and "acceptance criteria" presented in the context of this device's submission, along with other requested information where applicable.

Here's the information based on the provided text, adapted to your request format:

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

Note: For this traditional medical device, "acceptance criteria" means meeting the requirements of the specified ISO standards, and "reported device performance" indicates that the new device meets those requirements.

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

The document does not specify the sample size used for testing the piston syringes. It also does not explicitly state the provenance (e.g., country of origin, retrospective/prospective) of the data. The tests are referenced by ISO standards, implying laboratory testing.

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 as the device is a physical medical instrument (piston syringe), not an AI/ML device requiring expert ground truth for classification or diagnosis. Performance is evaluated against objective engineering standards (ISO 7886-1).

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent tasks, typically in AI/ML performance evaluation where human experts might disagree. The syringe's performance is determined by objective physical tests according to ISO 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. This is a submission for a physical medical device (piston syringe), not an AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this document.

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

This section is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective engineering standards and test methods defined in ISO 7886-1. The device is deemed to meet its performance criteria if it passes these standardized tests, indicating functional equivalence to the predicate device.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

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

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The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with BOTOX® is exclusively produced for use with BOTOX® Cosmetic (onabotulinumtoxinA).

The purpose of this request is for marketing clearance of Henke-Sass, Wolf piston syringe because we have added a new purple-colored plunger for a new version of the syringe. The piston syringes covered by this submission will have the same performance as already marketed devices. The only difference will be the coloring of the plunger in adding a master batch to the original material.

The provided text describes a 510(k) submission for a piston syringe, focusing on demonstrating substantial equivalence to predicate devices rather than a study with acceptance criteria and device performance in the context of diagnostic accuracy or AI assistance.

Therefore, many of the requested elements for describing such a study (e.g., acceptance criteria for diagnostic performance, sample size for test sets with data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.

The document primarily focuses on bench testing and compliance with recognized standards to show that the new syringe, with a color change to its plunger, performs identically to existing, cleared devices.

Here's the information that can be extracted from the provided text, with the understanding that it pertains to a medical device clearance for a syringe rather than a diagnostic algorithm study:

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

2. Sample sized 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 document. The submission references international ISO standards for testing but does not detail the specific sample sizes or provenance of data for each test. For a syringe, testing would typically involve a predefined number of units per lot to meet standard requirements, but these specifics are not included in this summary.

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 as the document describes a physical medical device (syringe) and its compliance with engineering and biological safety standards, not a diagnostic device relying on expert interpretation for ground truth.

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

This is not applicable for the same reasons as above.

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 this submission is for a physical syringe, not an AI-assisted diagnostic device or a study involving human readers.

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

This is not applicable as this submission is for a physical syringe, not an algorithm or AI device.

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

The "ground truth" for this device is based on compliance with established international standards (ISO standards) for material safety, physical performance, sterilization, and packaging, as well as demonstrating identical operating principles and intended uses to legally marketed predicate devices. There wouldn't be a "ground truth" in the diagnostic sense (like pathology or expert consensus).

8. The sample size for the training set

This is not applicable as this submission is for a physical syringe, not a machine learning or AI device that requires a training set.

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

This is not applicable for the same reasons as above.

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The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.

The Acacia Piston Syringe consists of a calibrated hollow cytincrical body and movable plunger. At the tip of the barrel is a tapered male connector, which can be in a luer lock, luer slip, oral lock, and oral slip configurations.

The Acacia Piston Syringe can also be used as a dispenser without the use of a plunger.

The provided document does not contain information regarding a study that proves the device meets acceptance criteria, beyond a general statement that "All necessary verification and validation testing has been performed for the Piston Syringe to assure substantial equivalence to the predicate devices."

Therefore, I cannot provide detailed information for most of the requested points.

Here's what can be inferred from the document:

• Device Name: Acacia Piston Syringe
• Purpose: A general-purpose Piston Syringe

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

The document does not specify quantitative acceptance criteria or detailed performance data. It broadly states that the device has "similar physical and technical characteristics to the predicate devices" and that "All necessary verification and validation testing has been performed... to assure substantial equivalence."

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

Not specified in the document.

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

Not applicable as specific testing details, including ground truth establishment or expert involvement, are not provided.

4. Adjudication method for the test set

Not applicable as specific testing details are not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not mentioned. The device is a physical medical device (piston syringe), not an AI-assisted diagnostic tool where human readers would be involved in interpreting images.

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

This concept is not applicable to a physical piston syringe. Performance would be assessed through engineering and materials testing, not algorithm-only performance.

7. The type of ground truth used

Not specified. For a physical device like a piston syringe, "ground truth" would likely refer to engineering specifications, material properties, and functionality tests (e.g., fluid volume accuracy, force required for plunger movement, sterility, biocompatibility).

8. The sample size for the training set

Not applicable as this is not an AI/algorithm-based device that requires a training set in the conventional sense.

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

Not applicable.

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The Omnifix piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body. The Omnican and Omnifix insulin syringes are intended for subcutaneous injection of insulin.

The Omnifix piston syringes consist of a graduated hollow barrel and a movable plunger with a plunger tip. One end of the barrel has a male connector (nozzle), which permits attachment to a female connector (hub). Both luer lock and luer slip nozzles are available, with centric and eccentric configurations. The Omnifix syringes will be available in 1 mL, 2 mL, 2.5 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 50 mL volume sizes, and as a 1 mL insulin syringe. The Omnican insulin syringes have an integrated needle bonded to the nozzle end of the syringes and are graduated in units of insulin. The Omnican insulin syringes will be available in sizes of 0.5 mL and 1 mL, and with a 30 gauge needle in lengths of 8 mm and 12 mm.

The provided document is a 510(k) summary for the B. Braun Omnifix® Piston Syringes and Omnican® and Omnifix® Insulin Syringes. It states that biocompatibility and functional testing were performed to verify the safety and effectiveness of the devices. However, it does not provide specific acceptance criteria or detailed results of these tests (e.g., specific thresholds for force, volume accuracy, etc.), nor does it describe the study methodology, sample sizes, or ground truth establishment.

Based on the provided text, the exact details needed for this request (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) are not available. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's description and intended use.

Therefore, the table and detailed answers below reflect the absence of this specific information in the provided 510(k) summary.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance
As indicated in the table above, the 510(k) summary states that "Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Omnifix and Omnican syringes." However, it does not explicitly define specific quantitative acceptance criteria or provide detailed numerical performance results for these tests. The document focuses on the conclusion that testing was performed and demonstrated safety and effectiveness in comparison to predicate devices, rather than presenting the raw data or specific thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not disclose the sample size used for the biocompatibility or functional testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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)
The document does not mention the use of experts to establish ground truth for any testing, as the testing appears to be primarily laboratory-based functional and biocompatibility assessments, not diagnostic interpretative tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no expert review or adjudication method is mentioned for establishing ground truth in this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical syringe, not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this device 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 concept of "ground truth" as typically applied in AI/diagnostic device studies (e.g., expert consensus, pathology) is not applicable here. For physical medical devices like syringes, "ground truth" would typically refer to established engineering standards, material properties, and biological responses (e.g., cell viability in biocompatibility, accurate force measurements for functional tests) rather than human expert interpretation of data. The document implies compliance with such standards through "biocompatibility and functional testing."

8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning 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 this device.

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The Dragon Heart Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.

The syringe has a graduated barrel, a plunger, a hub and a needle.

I apologize, but the provided text from the FDA 510(k) clearance letter for the Dragon Heart Piston Syringe does not contain the information needed to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

This document is a clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It does not typically include the detailed technical study reports or performance data that would address your specific questions about acceptance criteria and study methodologies.

To obtain that information, you would generally need to refer to the full 510(k) submission document, which is not provided here.

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This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

The covers are offered sterile, single use. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

The provided document describes the acceptance criteria and testing summary for the International Medsurg Connections Piston Syringe and Needles, submitted for 510(k) clearance (K022159).

1. Table of Acceptance Criteria and Reported Device Performance

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