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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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