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The Removal System Large Bore 60 cc Syringe is used with the Removal Catheters to inject fluids into or withdraw fluids and/or tissues from the body. It can be used for aspiration removal of fluid and/or tissue in the form of abscess fluid, infected materials, etc.

The Removal System Large Bore 60 cc Syringe is a general piston syringe constructed using a barrel, plunger, plunger seal, and large bore Toomey tip adapter that acts as a quick-release connector. The quick-release connector is compatible with the Removal System Catheters' sideport connector to establish an airtight seal. The twist-to-lock plunger with barrel tabs maintains the retracted position of the plunger.

The provided text describes information about the Inari Medical, Inc. Removal System Large Bore 60 cc Syringe (K233069).

Based on the provided document, this device is a simple piston syringe. The information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to non-clinical performance testing for mechanical integrity, biocompatibility, and sterilization, rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (like MRMC studies, expert ground truth for imaging, training/test set sample sizes for AI, etc.) are not applicable to this type of device submission.

Here's the breakdown of the relevant information from the document:

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

The document does not provide a direct table of specific numerical acceptance criteria alongside quantitative performance results for each test. Instead, it lists the types of tests conducted and states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." This indicates a qualitative summary of successful performance against predefined criteria internally established by the manufacturer, rather than reportable numerical results for public review.

Here's a summary of the types of performance tests mentioned:

• Sensitization
• Acute Systemic Toxicity
• Intracutaneous Reactivity
• Material-Mediated Pyrogenicity | "The passing results demonstrate that the subject device meets the biological safety requirements per ISO 10993-1." |
  | Sterilization Validation | EtO sterilization to achieve a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016. | "The Removal System is sterilized using EtO to achieve a sterility assurance level (SAL) of 10^-6 using a validated sterilization process..." |
  | Non-Clinical Performance Tests | - Packaging Inspection
• Leak Testing Syringe to Quick-Connect Adapter
• Vacuum Testing Syringe to Quick-Connect Adapter
• Air Leakage
• Simulated Pus Analog Removal
• Tensile Testing - Large Bore Syringe to Connector
• General, ISO 7886-1, Clause 6.1
• Limits for Acidity or Alkalinity, ISO 7886-1, Clause 6.2 & Annex A
• Limits for Extractable Metals, ISO 7886-1, Clause 6.3 & Annex A
• Lubricant, ISO 7886-1, Clause 7 (Paragraph 1)
• Tolerance on Graduated Capacity, ISO 7886-1, Clause 8
• Scale, ISO 7886-1, Clause 9.1
• Numbering of Scales, ISO 7886-1, Clause 9.2
• Overall Length of Scale, ISO 7886-1, Clause 9.3
• Position of Scale, ISO 7886-1, Clause 9.4
• Barrel Flanges, ISO 7886-1, Clause 10.2
• Design, ISO 7886-1, Clause 11.1
• Position of Nozzle on End of Barrel, ISO 7886-1, Clause 12.2
• Nozzle Lumen, ISO 7886-1, Clause 12.3
• Freedom from Liquid Leakage Past Plunger, guided by ISO 7886-1, Clause 13.2 & Annex D
• Freedom from Air Leakage Past Plunger, ISO 7886-1, Clause 13.2 & Annex B
• Force to Operate the Piston, ISO 7886-1, Clause 13.3 & Annex E
• Fit of Stopper/Plunger in Barrel, ISO 7886-1, Clause 13.4
• Particulate Matter | "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." |
  | Leveraged Performance Tests | - Pouch Seal Visual Inspection (from K191368 and K231848)
• Bubble Leak (from K231848)
• Dye Penetration (from K231848)
• Pouch Peel, Seal Strength (from K231108)
• Packaging Usability Evaluation for Aseptic Presentation (from K230494)
• Vacuum Testing Large Bore Syringe (from K191710)
• Simulated Use, Tensile Large Bore Syringe (from K191710) | "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." |

Regarding the other points:

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

• Sample Size: The document does not specify the exact sample sizes (number of syringes) used for each individual non-clinical performance test. This level of detail is typically found in the full test reports referenced by the submission, not the summary itself.
• Data Provenance: The tests are performance tests of a physical medical device. "Data provenance" as in geographic origin or retrospective/prospective data collection is not applicable here, as it pertains to clinical data or AI data sets. These are laboratory-based engineering tests.

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

• Not Applicable. This question relates to studies establishing "ground truth" for clinical diagnoses, typically in the context of AI or diagnostic imaging. For a physical device like a syringe, "ground truth" is established by engineering specifications, international standards (e.g., ISO 7886-1, ISO 10993-1, ISO 11135), and successful outcomes of validated test methods performed by qualified personnel in a laboratory setting. Experts would logically be engineers, material scientists, and sterilization specialists.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., in radiology studies). This is not relevant for physical device performance testing. The "adjudication" for these tests would involve ensuring that the test methods are followed correctly and that results are objectively measured against predefined acceptance criteria.

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. MRMC studies are specific to evaluating diagnostic performance, particularly with AI assistance in clinical imaging. This device is a manual piston syringe and does not involve AI or human "readers" in its primary function or evaluation for this submission. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence."

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

• Not Applicable. This question relates to AI algorithm performance. This device is a physical, non-AI medical device.

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

• Engineering Specifications and International Standards: The "ground truth" for this device's performance is whether it meets predefined engineering specifications (e.g., dimensions, materials, leak rates, force to operate) and complies with relevant international standards (e.g., ISO 7886-1 for sterile hypodermic syringes, ISO 10993 for biocompatibility, ISO 11135 for sterilization). The tests are designed to verify these physical and biological characteristics.

8. The sample size for the training set:

• Not Applicable. This question relates to AI model training. This device does not use AI.

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

• Not Applicable. This question relates to AI model training. This device does not use AI.

In summary: The provided FDA 510(k) summary is for a Class II manual medical device (piston syringe). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to a series of non-clinical, laboratory-based performance, biocompatibility, and sterilization validation tests conducted to demonstrate that the device meets established engineering specifications and international standards, thereby supporting its substantial equivalence to a predicate device. Clinical studies or AI-related evaluations were explicitly stated as "not required" for this submission.

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INT Vacuum Locking Syringe is intended for use only by physicians for adult patients to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a Vacuum Syringe is preferred (e.g., thrombus, abscess fluid, bile, urine, etc.)

The INT Vacuum Locking Syringe is used to inject or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g., thrombus, abscess fluid, bile, urine etc.). The Syringe consists of graduation lines, zero line, luer connector, nozzle lumen, seals, barrel, plunger, push-button, barrel flanges, locking column, locking piece and fiducial line. When the Syringe is used, it can be divided into two situations: normal suction in normal state and vacuum suction in locked state. Vacuum Locking Syringe is placed in a soft blister box which is composed of Tyvek 2FS and PE. The proposed device is sterilized by EO and intended for single use. The packaging form is sealed packaging and guarantees that the product is sterile until opening. The packaging can ensure the sterilized finished device during its shelf life of 3 years.

The provided text is a 510(k) summary for a medical device (INT Vacuum Locking Syringe) seeking FDA clearance. It describes non-clinical testing performed to establish substantial equivalence to a predicate device. However, it explicitly states "No clinical study is included in this submission."

Therefore, I cannot provide information regarding:

• Multi-reader multi-case (MRMC) comparative effectiveness study
• Effect size of human readers improving with AI vs. without AI assistance
• Standalone (algorithm only without human-in-the-loop performance) study

I can, however, extract information about the non-clinical acceptance criteria and testing that was performed.

Here's the breakdown of the information that can be extracted:

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

The document describes non-clinical performance testing conducted on the subject device against recognized standards. It states: "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." However, the specific quantitative acceptance criteria and the exact reported performance values (e.g., specific force in N, leakage volume) are not detailed in this summary. The summary only lists the items tested and the methodology/standards used.

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

The document mentions "non-clinical bench performance testing was conducted on the subject device" and lists various tests. However, it does not specify the sample sizes used for any of these tests.
Regarding data provenance, the testing was performed by the manufacturer, Shanghai Kindly Medical Instruments Co., Ltd., based in China, as part of their 510(k) submission. This is retrospective testing done to support the premarket notification.

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 as the document explicitly states "No clinical study is included in this submission" and the testing described is non-clinical bench testing. Ground truth for clinical studies typically involves expert assessment of patient data.

4. Adjudication method for the test set:

This information is not applicable as it pertains to clinical studies and expert consensus, which were not part of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "No clinical study is included in this submission." The device is a physical medical instrument (syringe), not an AI-powered diagnostic tool.

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

No, a standalone study (in the context of AI algorithm performance) was not done. The device is a physical syringe, and the testing described is bench performance testing for a medical instrument, not a software algorithm.

7. The type of ground truth used:

For the non-clinical performance and biocompatibility testing, the "ground truth" is defined by the acceptance criteria specified within the referenced international standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993-1, ASTM standards, USP standards) and the manufacturer's own in-house standards. Compliance with these established technical specifications and biological safety requirements serves as the ground truth for device performance and safety.

8. The sample size for the training set:

This information is not applicable as there is no "training set" in the context of this device and the non-clinical testing performed. This usually refers to machine learning models, which are not involved here.

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

This information is not applicable for the same reason as point 8.

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VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).

The VacLok™ AT Vacuum Syringe is a general piston syringe constructed using a barrel, plunger, piston seal, and locking mechanism. It is designed to lock in any position along the length of the barrel with the capability of holding a vacuum when the cam locking mechanism is engaged.

The provided text is a 510(k) summary for the Merit VacLok™ AT Vacuum Syringe, a medical device. This document focuses on demonstrating the device's substantial equivalence to predicate devices, primarily through performance bench testing against recognized international standards and biocompatibility testing. It does not describe an AI/ML-based device or a study involving human readers or expert consensus for establishing ground truth in an AI/ML context.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the acceptance criteria and performance testing that was conducted for this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device complies with FDA-recognized consensus standards ISO 7886-1 and ISO 594-2, and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." Specific acceptance criteria values are not explicitly listed in a table, but the areas of testing and the general statement of compliance serve as the "reported device performance."

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

The document does not specify the exact sample sizes (e.g., number of syringes) used for each bench test. The data provenance is also not detailed beyond the statement that testing was performed by the manufacturer against international standards. It's inherent to this type of device submission that testing is done in a controlled laboratory setting (prospective testing of manufactured devices), rather than using clinical patient data. The country of origin for the data (testing lab location) is not specified.

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

This question is not applicable as this is a medical device (syringe) performance evaluation, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical records. The "ground truth" for the device's performance is established by the specifications and acceptance criteria of the referenced ISO standards.

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

This question is not applicable as there is no human interpretation or subjective assessment being adjudicated. Device performance is measured objectively against predefined 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 question is not applicable as the device is a physical syringe, not an AI system.

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

This question is not applicable as the device is a physical syringe, not an algorithm. Bench testing evaluates the device's performance standalone relative to engineering standards.

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

The "ground truth" for this device's performance is based on the objective technical specifications and acceptance criteria outlined in recognized international consensus standards (e.g., ISO 7886-1, ISO 594-2) and the FDA's guidance documents for biocompatibility and sterilization.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of a physical medical device. Manufacturing processes are subject to quality controls and design validation, but not a data-driven "training" as in AI/ML.

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

This question is not applicable for the reasons stated above.

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