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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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The ClotTriever Thrombectomy System is indicated for:

• · The non-surgical removal of thrombi and emboli from blood vessels.
• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and the ClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.

The sheath is an introducer sheath with a distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).

The provided text is a 510(k) summary for the Protrieve Sheath, a medical device. It details the device's technical characteristics and the non-clinical testing performed to establish substantial equivalence to a predicate device.

Crucially, this document states: "Clinical testing was not required to support substantial equivalence." This means there was no clinical study involving human subjects for this specific submission to prove the device meets performance criteria, especially as it relates to AI/machine learning performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device, as the provided document does not pertain to an AI/ML device or a clinical study for performance.

The acceptance criteria mentioned in the document relate to the non-clinical (engineering and material) testing of the physical device to demonstrate mechanical and material properties are consistent with the predicate device, not performance benchmarks for an AI algorithm.

If you would like to know about the non-clinical acceptance criteria and the tests performed for this specific device, I can provide that information based on the text. However, it will not involve AI/ML performance, ground truth, expert consensus, or clinical effectiveness studies in the way your prompt describes.

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The WOLF Thrombectomy System, 14F is indicated for:
• The nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The WOLF Thrombectomy System, 14F is comprised of two single lumen variable stiffness catheters (WOLFcatheter & Devortex shaft) designed for use in removing clot from peripheral vessels. A funnel is attached to the distal end of the WOLF catheter to aid in ingestion of clot. The Devortex sleeve is attached to the Devortex shaft. When the Devortex shaft is pulled, it inqests the clot into the WOLF catheter. The WOLF catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot.

The Devortex shaft has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The WOLF catheter has one radiopaque marker band at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion.

The WOLF Thrombectomy Sheath consists of a sheath, dilator and syringe. An active hemostatic valve is integrated at the proximal end of the sheath which can be manually opened for device introduction to provide hemostasis and minimize blood loss. The distal end of the sheath features a radiopaque marker forrecognition under fluoroscopy. The hemostasis valve is coupled with a large bore side port and is accompanied with a VacLok syringe for aspiration.

The provided document is a 510(k) summary for the WOLF Thrombectomy System, 14F. It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices through various performance tests. However, this document does not contain information related to an AI/ML device or its acceptance criteria and study results.

The document primarily focuses on the physical and mechanical properties of a medical device (a thrombectomy system) and its biocompatibility, sterilization, and packaging. It mentions "performance data" and "bench studies" that verify the device performs as intended with respect to its design inputs, including metrics like durability, integrity, kink resistance, and tensile strength. It also refers to "simulated use validation" and "animal testing" (primarily for the predicate device, with an acute study in an ovine model for radiopacity of the sheath).

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance for an AI/ML device, as the provided text is about a physical medical device and does not involve AI or ML.

If you have a document describing an AI/ML medical device and its validation studies, please provide that, and I would be happy to assist.

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The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.

The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from the FlowTriever Retrieval/Aspiration System embolectomy procedure. The sterile (EO), single use FlowSaver Blood Return System is comprised of 2 components: • FlowSaver Blood Filter • 60 cc Luer Lock Syringe The FlowSaver Blood Filter has a sideport with a female quick connector for connection to the 60 cc Large Bore Vacuum Syringe (provided with Triever Catheter). Another standard Luer lock 60 cc syringe (provided) is attached to the needleless valve integrated into the FlowSaver's cap. The aspirant from a Triever Catheter embolectomy procedure is injected into the FlowSaver Blood Filter. Blood passes through the FlowSaver's dual layer 40 μ/200 μ polyester screen filter, filling the 60 cc syringe pre-connected to the female Luer Lock that is integrated into the cap of the filter housing. The 60 cc syringe is disconnected and its contents are injected through a suitable transfusion filter (minimum requirement 40 micron filter) prior to immediately reinjecting collected blood through an access sheath or catheter. FlowSaver's threaded cap with filter may be detached allowing rinsing with saline to remove thrombus and permit re-use if another Triever aspiration is performed. The FlowSaver may be used for up to five filtrations.

The provided text is a 510(k) summary for the Inari Medical FlowSaver Blood Return System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against specific acceptance criteria for an AI/device's diagnostic or predictive capabilities. Therefore, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving a device meets these criteria, especially concerning AI performance, MRMC studies, or specific ground truth methodologies.

The document details:

• Device Description: The FlowSaver Blood Return System accessory is used with Triever Catheters for autologous blood transfusion. It consists of a FlowSaver Blood Filter and a 60 cc Luer Lock Syringe. It filters aspirated blood through dual-layer 40 µ/200 µ polyester screens.
• Intended Use: Autologous blood transfusion.
• Comparison to Predicate: The FlowSaver is compared to the CellTrans Postoperative Autotransfusion Set (K024097) and deemed substantially equivalent due to similar intended use and technological characteristics (filtration through 40-micron filters, vacuum aspiration, polyester screens).
• Non-Clinical Testing: A list of verification and validation tests performed to demonstrate compliance with product requirements, including:
  • Visual and Dimensional Inspection
  • Engagement & Disengagement Force Testing
  • Flow Rate Testing
  • Media Integrity testing
  • Leakage Testing
  • Vacuum Testing
  • Clot Burden Filtration Validation
  • Preconditioning/Simulated Use and Tensile/Torque Testing
  • Burst Testing
  • Hematocrit Testing
  • Mechanical Hemolysis Testing
  • Filtration Efficiency
  • Particulate Matter Determination
• Biocompatibility Testing: Conducted according to ISO 10993-1 guidelines, passing various tests such as Elution, Sensitization, Intracutaneous Injection, Systemic Injection, Pyrogen, Hemolysis, UPTT, Complement Activation, and Platelet/Leukocyte Count.
• Clinical Testing: "Clinical testing was not required for the determination of substantial equivalence."

In summary, there is no information in this document about:

• A table of acceptance criteria for diagnostic/predictive performance.
• Reported device performance against specific metrics (e.g., sensitivity, specificity, AUC).
• Sample size for test sets, data provenance related to AI.
• Number of experts, their qualifications, or adjudication methods for ground truth in an AI context.
• MRMC studies or effect sizes of human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used for AI (as this is not an AI device).
• Training set sample size or how its ground truth was established for an AI model.

This document is a regulatory submission for a medical device that performs a mechanical function (blood filtration for autotransfusion), not an AI/ML-driven diagnostic or treatment support system. Therefore, the questions related to AI performance, ground truth, and reader studies are not applicable to the content provided.

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