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The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.

The Impella CP Introducer is packaged as a sterile kit. which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

This document (K192769) outlines the 510(k) submission for the Impella CP Introducer. However, it explicitly states that no additional qualification testing was required for the substantial equivalence determination because the device is identical to its commercially available predicate device, the Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in this document, as such a study was deemed unnecessary for this submission.

Here's a breakdown of why this information isn't available based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not available because no new performance testing was conducted. The device is considered to perform identically to its predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new test set was used.

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): Not applicable, as no new test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new test set was used.

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 an introducer, not an AI or imaging device, so MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no new testing or ground truth establishment was required.

8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the K192769 submission for the Impella CP Introducer relies entirely on its substantial equivalence to a predicate device (Oscor Introducer set, Model Adelante-S2 Introducer, K122084) due to their identical design, manufacturing, and performance characteristics. Therefore, the document does not contain details about new acceptance criteria or a study to prove their fulfillment.

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The Transseptal Introducer is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. The Transseptal Introducer is intended for single use only.

The Transseptal Introducer consists of a high-density polvethylene (HDPE) sheath, a dilator with a lubricious hydrophobic coating, and an uncoated introducer quidewire in a dispenser. The transseptal introducer comes in two French sizes, 8F and 8.5F, two lengths, 63cm and 81cm, and two curves, LO (50°) and L1 (40°, 51°). The components of the Transseptal Introducer include the transseptal sheath, transseptal dilator, introducer guidewire with dispenser, sterile packaging and labeling. There are eight model numbers: TSIL0863, TSIL1863, TSIL0881, TSIL1881, TSIL08563, TSIL18563, TSIL08581, and TSIL18581. The Transseptal Introducer is sterilized by 100% ethylene oxide cycle and is for single-use only. The Transseptal Introducer is used in a healthcare facility/hospital.

The Transseptal Introducer is used in transseptal procedures to introduce cardiovascular catheters into the left side of the heart after transseptal access was achieved with a transseptal needle and dilator. The device is used by inserting the device through the femoral vein in conjunction with a transseptal needle. The introducer quidewire is inserted through the femoral vein and guides the needle up to the fossa ovalis in the right atrium. The needle punctures the fossa ovalis and the dilator is used to insert and dilate the fossa further where the needle has punctured. This allows the sheath to cross and creates access to the left side of the heart. The introducer's duration in the body is less than 24 hours.

Based on the provided text, the document describes a 510(k) premarket notification for a medical device (TSI Transseptal Introducer), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo clinical effectiveness. Therefore, the information typically associated with acceptance criteria and a study proving a novel device's performance (such as an AI algorithm's performance) is not present in this document.

For a 510(k) submission like this, "acceptance criteria" are generally related to engineering and performance verification tests to show the device functions as intended and is equivalent to the predicate, not clinical accuracy or diagnostic performance in the way an AI often requires. The "study" here is primarily a series of bench and biocompatibility tests, not a clinical study involving human patients or ground truth established by experts for diagnostic purposes.

Here's a breakdown of why many of your requested points cannot be answered from this document, and what is provided instead:

Information NOT Applicable/Present for this Type of Device Submission:

• Acceptance Criteria Table (Diagnostic Performance): This device is a catheter introducer, not a diagnostic tool or AI. Its "performance" is demonstrated through engineering and biocompatibility tests, not diagnostic metrics like sensitivity/specificity.
• Sample size for the test set (Diagnostic): No diagnostic test set is mentioned. The sample sizes would apply to the quantities of devices tested in bench studies.
• Data provenance (Diagnostic): Not applicable for bench tests.
• Number of experts and qualifications (Diagnostic Ground Truth): Not applicable as there's no diagnostic ground truth to establish.
• Adjudication method (Diagnostic): Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This is typically for evaluating diagnostic tools where human readers interpret data, often with AI assistance. It's not relevant for a transseptal introducer.
• Effect size of human reader improvement with AI assistance: Not applicable as there is no AI component.
• Standalone (algorithm only) performance: Not applicable as there is no algorithm.
• Type of ground truth (expert consensus, pathology, outcomes data): Not applicable, as the "ground truth" for a device like this is its physical properties meeting specifications and biocompatibility.
• Sample size for the training set: There is no AI model or training set.
• How the ground truth for the training set was established: Not applicable.

What the Document Does Provide (Related to "Acceptance Criteria" for a Device Submission of this Type):

The "acceptance criteria" for a 510(k) of a traditional medical device are met by demonstrating substantial equivalence to a predicate device through:

1. Direct Comparison of Characteristics: Showing the subject device has similar design, materials, and intended use as the predicate.
2. Performance Testing: Bench tests to confirm the device functions as expected and safely.
3. Biocompatibility Testing: Demonstrating the materials are safe for human contact.

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

As mentioned, a formal table of diagnostic acceptance criteria with specific performance metrics (like sensitivity, specificity, AUC) is not provided because this is a physical medical device, not a diagnostic algorithm.

Instead, the document lists "Performance Testing" and "Biocompatibility Data" as the studies performed to support substantial equivalence. The acceptance criterion for these tests is implicitly that the device performs equivalently or within acceptable limits to ensure safety and effectiveness, similar to the predicate.

Reported Device Performance (as stated in the document):
"The results of the testing demonstrated the subject device performed equivalently to the predicate device."
"The Transseptal Introducer met the requirements set forth in ISO-10993."

Summary of "Performance Tests" (acting as the "study" for this type of device):

• Particulate testing (USP , Light Obscuration Method)
• Liquid leakage from sheath introducers under pressure
• Air pressure leak test
• Sideport-stopcock-hub tug test
• Sheath joint pull tests
• Guidewire restriction
• Curve template inspection
• Dilator flexibility testing
• Corrosion resistance
• Guidewire tensile strength
• Fracture and flex testing
• Curve integrity testing
• Packaging testing
• In vitro simulated use
• Surface morphology assessment | The results of the testing demonstrated the subject device performed equivalently to the predicate device. |
  | Sterilization Validation | - Validated in accordance with ANSI/AAMI/ISO 11135-1 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices). | Sterilized to a SAL of 10^-6^. |
  | Biocompatibility | - ISO 10993-5 Cytotoxicity
• ISO 10993-10 Sensitization
• ISO 10993-10 Irritation/Intracutaneous Reactivity
• ISO 10993-11 Acute Systemic Toxicity
• ISO 10993-11 Pyrogenicity
• ISO 10993-3 Genotoxicity
• ISO 10993-4 Hemocompatibility ASTM Hemolysis Complete
• ISO 10993-4 Hemocompatibility - Complement Activation Complete with C3a & SC5b-9
• ASTM F2382-17 Partial Thromboplastin Time (PTT) testing
• Platelet/Leukocyte Count (Guideline: ASTM F2888-13) | The Transseptal Introducer met the requirements set forth in ISO-10993. (Considered an external communicating device with circulating blood contact and limited exposure (less than 24 hours)). |

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

• Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for engineering validation. (e.g., "The results of the testing demonstrated...") This is typical for bench testing where the focus is on meeting specifications rather than generalizability to a patient population.
• Data Provenance: Not applicable. These are laboratory-based engineering and biological tests, not patient data from specific countries.

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)

• Not applicable. There is no ground truth established by medical experts in the context of diagnostic accuracy for this device. The "ground truth" is that the device physically meets its engineering specifications and is biocompatible.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic studies. Bench tests follow objective pass/fail 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

• No, this type of study was not done. It is not relevant for a catheter introducer.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and biocompatibility requirements (e.g., ISO 10993 standards) which are objectively measured.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not an AI model.

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

• Not applicable.

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