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The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Introducer Kit is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion.

The Abiomed 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end and a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

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The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Introducer Kit (Gen 2) is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion. The 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

This looks like a 510(k) summary for a medical device, specifically an introducer kit. The document describes the device, its intended use, and comparison to a predicate device. However, it does not contain the level of detail regarding acceptance criteria, study design, and performance metrics that would be expected for a typical AI/ML-based medical device described in the prompt's request.

Here's why and what information can be extracted:

This is NOT an AI/ML Medical Device.
The device described, the "Abiomed 14Fr Low Profile Introducer Kit," is a physical medical device (a catheter introducer) and not an AI/ML software device. This means the requested information about AI model performance, training sets, ground truth establishment methods, human reader studies, etc., is not applicable to this document. The "performance testing" section refers to traditional bench tests for physical device characteristics (e.g., visual inspection, mechanical testing, coating integrity, sterility, biocompatibility).

Therefore, I cannot populate most of the requested fields accurately as they pertain to AI/ML models.

However, I can extract the relevant information regarding the device's acceptance criteria and the type of study performed to show it met these criteria, as presented in the document for this physical device.

Information Extracted (Interpreted for a non-AI/ML device):

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

   • Acceptance Criteria for a Physical Device: The document states that performance testing "met the acceptance criteria." While specific numerical criteria are not listed, the implied criteria would be successful completion of each bench test without failure.
   • Reported Device Performance: "showed that the subject device, Abiomed 14Fr Low Profile Introducer Kit (Gen2), met the acceptance criteria and demonstrated substantial equivalence for its intended use."

   Acceptance Criteria (Implied for physical device)	Reported Device Performance
   Device passes specified bench tests	Met acceptance criteria
   Demonstrates substantial equivalence	Demonstrated substantial equivalence for intended use
   Biocompatibility: Safe for patient contact	Passed ISO 10993-1
   No new safety or performance issues identified	None identified

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

   • Sample Size: Not specified for individual tests.
   • Data Provenance: Not applicable as these are bench tests on manufactured device samples, not patient data.

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 physical device is typically established through engineering specifications, material science, and regulatory standards, not expert consensus on patient data.

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

   • Not applicable.

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 is not an AI-assisted device.

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

   • No. This is not an AI algorithm. The device performance (standalone) was assessed through bench testing.

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

   • For a physical device, ground truth is based on engineering specifications, material properties, and established regulatory standards (e.g., ISO 10993 for biocompatibility, defined mechanical test parameters).

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable.

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The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.

The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.

The provided text is a 510(k) summary for the preCARDIA Occlusion System. It details the device, its intended use, and a comparison with predicate devices. While it lists various performance tests conducted, it does not contain specific acceptance criteria or the reported device performance for an AI/ML-based device.

The document outlines bench testing and an animal study to evaluate the performance of the preCARDIA Catheter. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for an AI/ML context.
• Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Details on MRMC studies or a standalone algorithm performance.
• The type of ground truth used relevant to AI/ML (e.g., pathology, outcomes data).
• Sample size for a training set or how ground truth was established for AI/ML training data.

The text is for a physical medical device (vascular clamp/occlusion system), not an AI/ML algorithm. Therefore, the concepts requested in the prompt, such as "acceptance criteria for an AI/ML model," "training set," "test set," "ground truth," "expert consensus," and "MRMC study," are not applicable to the content provided.

Based on the provided document, I cannot fulfill the request as it pertains to AI/ML device validation. The document describes the regulatory submission for a physical medical device and its associated non-AI/ML performance testing.

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The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.

The Abiomed OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up to six hours in duration. The OXY-1 System includes:

• A Disposable pump and oxygenator .
• A Pump Driver (blood pump) ●
• Blood tubing .
• A Console for controlling the pump and managing gas flow .
  These components are designed to operate together, simplify operation, and reduce the overall equipment footprint at the bedside.

The provided text is a 510(k) summary for the Abiomed OXY-1 System, a cardiopulmonary bypass oxygenator. It is not a document describing an AI/ML-driven medical device, nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them, specifically in the context of an AI/ML device, as the provided document pertains to a traditional medical device (a cardiopulmonary bypass oxygenator).

The information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are all relevant to the validation of AI/ML models. Since this document describes a physical medical device, these concepts are not applicable.

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The 14 Fr Low Profile Introducer Set is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Introducer Set is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Set consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" quidewire. The 14Fr Low Profile Introducer Set is kitted with an 0.035" access quidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion.

The 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14 Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14 Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

This document describes the FDA's 510(k) clearance for the Abiomed 14Fr Low Profile Introducer Set. The information provided heavily focuses on the comparison to predicate devices and performance testing. However, it does not explicitly state acceptance criteria in a quantitative format, nor does it detail a clinical study with human patients, as the clearance was based on bench testing and substantial equivalence to predicate devices.

Let's break down the available information based on your request:

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

The document broadly states that the device "met the acceptance criteria," but it does not specify what those criteria are in a numerical or categorical table format for each test. Instead, it lists the types of tests performed.

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

• Sample Size for Test Set: Not specified for each individual bench test. The document mentions "Performance testing (bench) was completed," but doesn't detail the number of units tested for each specific test.
• Data Provenance: The document does not specify the country of origin of the data. The study was a retrospective evaluation based on bench testing, as it states "No clinical data were required to demonstrate substantial equivalence."

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 there was no test set involving human data or expert review to establish ground truth in the traditional sense for medical imaging or diagnostic devices. The acceptance was based on engineering and biocompatibility bench testing.

4. Adjudication method for the test set:

• Not applicable. There was no human-reviewed test set requiring adjudication in the context of this 510(k) submission.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical data were required to demonstrate substantial equivalence." This type of study would involve human readers and clinical cases, which was not part of this clearance process.

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

• Not applicable. This device is a physical medical introducer set, not an AI algorithm. Therefore, "standalone" performance for an algorithm is not relevant. The performance evaluated was the device's physical and functional attributes through bench testing.

7. The type of ground truth used:

• The "ground truth" for this device's performance was established via engineering specifications, material science standards, and biocompatibility standards (e.g., ISO 10993-1). For example, "leak testing" would have a pre-defined maximum allowable leak rate as its ground truth, based on engineering requirements for a safe and effective introducer.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As stated above, there is no "training set" for this type of device.

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INTENDED USE:

The Impella XR Sheath Set is intended to facilitate femoral access to the vascular system.

INDICATIONS FOR USE:

The Impella XR Sheath Set is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.

The Impella XR Sheath Set is a sterile, single-use, prescription device. The Impella XR Sheath Set consists of an introducer sheath (Impella XR Introducer Sheath) and a tapered sheath dilator (Impella XR Dilator) which is compatible with a 0.035" guidewire. The Impella XR Sheath Set is kitted with a 0.035" access quidewire and a supplemental dilator in the Impella XR Sheath Kit for convenience to help facilitate insertion.

The Impella XR Introducer Sheath consists of a sheath hub with a three-way stop cock and flush port at its proximal end and an expandable sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stop cock and flush port, a butterfly (suture pad), and connects with the dilator hub. The sheath body has an insertion profile of 10 Fr and expands after removal of the dilator to allow the insertion of the Impella 2.5 catheter. The sheath body also features a hydrophobic coating to aid in the insertion of the introducer sheath.

The Impella XR Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub.

The provided document describes the Impella XR Sheath Set, a medical device for introducing catheters, and its substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria and study details typical of an AI/ML medical device submission. Specifically, it does not include:

• A table of acceptance criteria with reported device performance for an AI/ML algorithm.
• Sample sizes for test sets, data provenance, or details about ground truth establishment by experts for AI/ML performance evaluation.
• Information on MRMC comparative effectiveness studies or standalone AI algorithm performance.
• Details regarding training set size or how ground truth was established for a training set (which are relevant to AI/ML devices).

The document is for a traditional catheter introducer device, and the performance testing mentioned (Visual Inspection, Dimensional Verification, Packaging, Sterilization, Shelf Life, Biocompatibility, and a GLP animal study) relates to the physical and biological characteristics of this type of hardware, not to an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I cannot provide the requested information for an AI/ML device based on the given text.

If this were an AI/ML device submission, the requested information would typically be found in dedicated sections describing the clinical validation study, often including sensitivity, specificity, AUC, and other performance metrics against established acceptance criteria, along with detailed methodologies for data collection, expert review, and ground truth generation.

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The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.

The Breethe® OXY-1 System provides extracorporeal circulation for full or partial cardiopulmonary bypass support for up to six hours. The OXY-1 System includes; a disposable pump and oxygenator, a pump driver, blood tubing, and a console for powering and controlling the pump and managing gas flow. These components are designed to operate together to reduce the overall equipment footprint at the bedside.

The provided text is a 510(k) Summary for the Abiomed OXY-1 System, a cardiopulmonary bypass oxygenator. It outlines the device's characteristics, comparison to predicates, and performance data submitted to the FDA for substantial equivalence determination.

However, the document does not contain information related to a study involving acceptance criteria for an AI/ML medical device, human reader performance, ground truth establishment by experts, or MRMC studies. The performance data mentioned (Biocompatibility, Electrical Safety, Software V&V, and Performance Testing per FDA guidance) relates to the physical and functional aspects of the OXY-1 System hardware and software, typical for a Class II medical device of this type, not an AI/ML diagnostic or prognostic system.

Therefore, I cannot extract the information required by your request from the provided text, as the request is geared towards an AI/ML device study, which is not described herein.

To fulfill your request, I would need a document detailing the clinical validation or performance study of an AI/ML medical device.

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The Abiomed 23 Fr Sheath is intended for introduction of pacing leads or catheters.

The Abiomed 23 Fr Sheath 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, the Oscor 23 Fr Adelante-S2 Introducers, K122084.

The provided text is related to an FDA 510(k) premarket notification for a medical device called the "Abiomed 23 Fr Sheath." It is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it states that the device is identical to a previously cleared predicate device, and therefore, no additional qualification testing was required for substantial equivalence.

Therefore, I cannot provide the requested information from the given text as it explicitly states that no such studies or acceptance criteria comparisons were performed for this specific 510(k) submission.

Here's a breakdown based on the information provided, and why most of your questions cannot be answered from this document:

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

• Not Applicable. The document explicitly states: "Since the Abiomed 23 Fr Sheath is identical to its commercially available predicate device, no additional qualification testing was required for the substantial equivalence determination." Therefore, no new acceptance criteria or reported device performance data is presented.

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

• Not Applicable. No new testing was performed for this 510(k) submission. The substantial equivalence is based on the device being identical to the predicate.

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. No new ground truth establishment or expert review was part of this submission, as no new testing was conducted.

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

• Not Applicable. No test set was generated for this 510(k) 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 catheter introducer sheath, not an AI or imaging device, so MRMC studies are not relevant. This document is a regulatory clearance for a physical medical device.

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

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. No new ground truth was established for this submission.

8. The sample size for the training set

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. This is not an AI algorithm.

Summary from the provided text:

The Abiomed 23 Fr Sheath obtained 510(k) clearance (K201116) by demonstrating substantial equivalence to a predicate device, the Oscor Adelante-S Introducer Series (K122084).

The basis for this substantial equivalence is that the Abiomed 23 Fr Sheath is identical to its commercially available predicate device in terms of "design, packaging, manufacturing, sterilization, and labeling." Because of this asserted identity, no additional qualification testing was required for this specific 510(k) submission. Therefore, the document does not contain information about new acceptance criteria or studies performed to demonstrate performance.

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