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The pREBOA-PRO™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The pREBOA-PRO™ Catheter balloon is designed with flow channels to enable the clinician precise, smooth control during inflation and deflation. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use. The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a quidewire. In addition, the catheter is compatible with guidewires up to 0.025" that can be used to facilitate subsequent vascular procedures affer a REBOA procedure. A peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line Pressure Relief (safety) Valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The peel-away sheath can be separated from the catheter shaft affer insertion if needed. The device is a single-use, sterile device.

The pREBOA-PRO Catheter is a medical device intended for temporary occlusion of large vessels and blood pressure monitoring, particularly in patients requiring emergency control of hemorrhage. The provided document is a 510(k) summary, which indicates that the device is seeking substantial equivalence to a legally marketed predicate device (ER-REBOA™ Catheter, K172790).

The document details performance data including various bench and in vivo animal tests to demonstrate the safety and effectiveness of the modifications made to the pREBOA-PRO Catheter compared to its predicate. Additionally, a retrospective clinical study using the predicate device is summarized to support the concept of partial REBOA, which the pREBOA-PRO Catheter is designed to facilitate with improved control.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance values for the pREBOA-PRO Catheter in a pass/fail format. Instead, it lists various "in vitro bench tests" and "in vivo animal tests" that were performed to demonstrate that the device "meets applicable design and performance requirements."

However, based on the types of tests mentioned, we can infer some of the performance aspects that were evaluated. For a medical device submission seeking substantial equivalence, "acceptance criteria" are often implicitly linked to demonstrating performance comparable to the predicate device and meeting recognized standards.

Here's a generalized table reflecting the types of performance assessed, acknowledging that specific numerical criteria are not provided in this summary:

It's crucial to note that the specific numerical targets or thresholds for "meets requirements" are not detailed in this summary. These would typically be found in the full submission to the FDA.

2. Sample Size Used for the Test Set and the Data Provenance:

The document describes two main categories of studies:

• Bench and Animal Tests (for pREBOA-PRO Catheter itself):

  • Sample Size: Not explicitly stated for individual bench tests (e.g., how many catheters were tested for burst strength, fatigue, etc.).
  • Data Provenance: Not explicitly stated for the bench tests. For the in vivo animal tests, they were conducted using porcine and ovine models. These are prospective animal studies designed to evaluate the new device.

• Clinical Study (Retrospective, using the predicate ER-REBOA™ Catheter):

  • Sample Size: 46 patients were included in the retrospective clinical study.
  • Provenance: This was a retrospective analysis of data collected from a local prospectively collected database at a major US trauma center. The data was collected between January 2016 and May 2019. The information indicates the data is from the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not provided in the document.

For the retrospective clinical study, the "ground truth" would generally be established by clinical outcomes and diagnoses within the patient medical records. The study refers to "electronic data and local REBOA registry", implying that medical professionals (e.g., trauma surgeons, intensivists) made the clinical decisions and recorded outcomes. However, the exact number and qualifications of experts involved in data abstraction, adjudication, or "ground truth" determination for the study are not specified.

For the animal studies, the "ground truth" is measured physiological responses and observations, typically assessed by veterinarians and research personnel. Their specific qualifications are not mentioned.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

For the retrospective clinical study, it's unclear if any formal adjudication process was used to resolve discrepancies in patient data or outcomes. For bench and animal studies, "adjudication" in the sense of expert consensus on outcomes is less common; results are typically based on objective measurements and observations by the study team.

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 (MRMC) comparative effectiveness study was not done. This device (pREBOA-PRO Catheter) is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human "readers" interpreting cases with or without AI assistance. Therefore, the concept of "effect size of how much human readers improve with AI" is not applicable here.

The document discusses the clinical effectiveness of a technique (REBOA, specifically partial REBOA) and the device's role in facilitating that technique, but not cognitive assistance.

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

No, this refers to a physical medical device, not a standalone algorithm. The "performance data" section details the device's mechanical, functional, and biological performance characteristics, evaluated through bench and animal testing. These are assessments of the device itself, akin to "standalone" performance for a physical product.

7. The Type of Ground Truth Used:

• For Bench Tests: The "ground truth" for bench tests is based on engineering specifications, recognized standards, and objective measurements of the device's physical and functional properties. For example, "balloon burst" would have an objective standard for acceptable pressure.
• For Animal Studies: The "ground truth" is based on physiological measurements (e.g., blood pressure, blood flow), observed performance (e.g., occlusion success, ease of deployment), and pathological findings from the animal models. This is considered outcomes data from an experimental setting.
• For Retrospective Clinical Study (using predicate device): The "ground truth" was derived from patient medical records, clinical outcomes data (e.g., mortality, organ failure, ventilator days, dialysis, vasopressor requirements), and the local REBOA registry. This is essentially retrospective clinical outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable in the conventional sense for this type of device submission.

• The pREBOA-PRO Catheter is a physical medical device. It does not employ machine learning algorithms that require a "training set" of data.
• The "Performance Data" describes validation and verification testing, not a training process.
• The "Real World Evidence" clinical study using the predicate device is an observational study of clinical outcomes, not a dataset used for "training" an algorithm.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no "training set" in the context of an AI algorithm described for this device. The "ground truth" for the device's design and testing (as described in point 7) was established through engineering principles, adherence to standards, and direct measurement in laboratory and animal settings, and for the retrospective study, through recorded clinical outcomes.

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The ER-REBOA™ PLUS Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The ER-REBOA™ PLUS Catheter is a large vessel occlusion catheter. The device consists of an atraumatic distal tip (P-tip®), a compliant occlusion balloon and catheter shaft with a built-in central lumen for blood pressure monitoring. The catheter has a uni-body design and is intended to be placed and advanced without a guidewire. However, the catheter is compatible with straight tipped guidewires up to 0.025″ and may be used with a guidewire if desired to facilitate subsequent vascular procedures. The catheter contains two lumens which traverse the length of the catheter and connect to extension lines with stopcocks. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. Radiopaque marker bands are located on the catheter at the balloon to assist with positioning under fluoroscopy. A peel-away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip® into an introducer sheath hemostasis valve.

This submission (K193440) describes the clearance of the ER-REBOA™ PLUS Catheter, which is an updated version of the predicate ER-REBOA™ Catheter (K172790). The primary change in the new device is the ability to be used with a 0.025" or smaller guidewire, which the predicate device could not accommodate.

The provided text discusses Performance Data but does not present a formal table of acceptance criteria and reported performance with quantitative values. However, it states that "Testing demonstrated that the changes had the desired effect, i.e., to allow passage of a 0.025″ or smaller straight-tip guidewire, but no unintended adverse effects." This implies that the device met the acceptance criteria for the tested performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or reported values. The information below is inferred from the description of the performance testing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size used for the bench tests (tensile strength, blood pressure, guidewire compatibility).
• Data Provenance: The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given that it's bench testing, it is likely laboratory-based and conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not Applicable. The described performance testing (tensile strength, blood pressure, guidewire compatibility) are bench tests that do not typically require expert interpretation of results to establish ground truth in the same way clinical imaging studies do. The ground truth would be based on direct measurements and adherence to engineering specifications.

4. Adjudication Method for the Test Set

• Not Applicable. Since the tests described are bench tests and not clinical studies requiring human interpretation of outputs, an adjudication method for a test set is not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document does not mention an MRMC comparative effectiveness study. The submission describes bench testing for a device modification, not AI performance.

6. Standalone (Algorithm only without human-in-the-loop) Performance

• Not Applicable. This device is a physical medical catheter, not an algorithm or AI system, so standalone algorithm performance is not relevant.

7. Type of Ground Truth Used for Performance Testing

• The ground truth for the performance testing (tensile strength, blood pressure, guidewire compatibility) would be based on engineering specifications, physical measurements, and functional verification according to predetermined test protocols. For example, guidewire compatibility would be demonstrated by the physical ability of the specified guidewire to pass through the catheter.

8. Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not relevant.

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The ER-REBOA Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The ER-REBOA™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a compliant occlusion with an atraumatic distal tip (P-tip®), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The cather has a unibody design and is designed to be used without a guidewire. A peel away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip® into an introducer sheath hemostasis valve. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device. The distal tip (P-tip®) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A co-axial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheter's two lumens. The peel-away sheath can be separated from the catheter shaft after insertion if needed.

Here's an analysis of the provided text regarding the ER-REBOA Catheter (K172790), focusing on acceptance criteria and supporting study details:

Summary of Acceptance Criteria and Device Performance (as inferable from the document):

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics for the device itself (e.g., burst pressure, inflation time, etc.). However, the primary "acceptance criteria" discussed relate to equivalence to a predicate device and the justification for removing a pregnancy contraindication.

The performance data section focuses on demonstrating the safety and effectiveness of using the REBOA catheter in pregnant patients, which implicitly means the device performs acceptably in this population.

2. Clinical Study: A retrospective case series study of 36 patients treated with fluoroscopy-free REBOA for severe postpartum hemorrhage.

• REBOA success rate: 100%
• REBOA-related mortality: 0% |

Detailed Analysis of the Study and Ground Truth:

The document describes a single study related to the change in labeling regarding pregnancy.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 36 patients
   • Data Provenance: Retrospective case series study. The country of origin is not specified.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not specified. The study is a "case series," which implies clinical outcomes were observed and recorded by treating physicians, but the process of establishing a formal "ground truth" by independent experts for the purpose of the submission is not detailed. The "REBOA success rate" and "REBOA related complications" likely refer to the clinical assessment of the treating medical teams.

3. Adjudication Method for the Test Set:

   • Not specified. Given it's a retrospective case series, a formal adjudication method by a separate panel for the purpose of this submission is unlikely to have been carried out or documented in this summary.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This type of study (MRMC) is typically used for diagnostic or imaging-based devices where different readers interpret data. The ER-REBOA Catheter is an interventional therapeutic device. The study described focuses on clinical outcomes in a specific patient population.

5. If a Standalone Study Was Done:

   • Yes, implicitly. The retrospective case series assessed the outcomes of the REBOA procedure using the device in a specific clinical context (postpartum hemorrhage) without comparing it directly to human readers or other diagnostic methods. It evaluated the device's performance in a clinical setting.

6. The Type of Ground Truth Used:

   • Clinical Outcomes/Expert Judgment (Implicit): The "REBOA success rate" and "no patients died from REBOA related complications" are based on clinical assessments and outcomes reported by the medical professionals involved in the care of those 36 patients. This is essentially ground truth established by the treating clinicians through observation of patient response and medical records.

7. The Sample Size for the Training Set:

   • Not applicable. The described study is a case series for proving clinical benefit/safety in a specific population for labeling purposes, not a study to train a machine learning algorithm. The ER-REBOA Catheter is a physical medical device, not an AI/ML algorithm.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The ER-REBOA™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The ER-REBOA™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a compliant occlusion balloon with an atraumatic distal tip (P-tip®), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The catheter has a uni-body design and is designed to be used without a quidewire. A peel away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip® into an introducer sheath hemostasis valve. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device. The distal tip (P-tip®) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A coaxial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the center of the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheter's two lumens. The peelaway sheath can be separated from the catheter shaft after insertion if needed.

This is an excellent question that breaks down the specifics needed to understand the validity and scope of a medical device's approval! Unfortunately, the provided text describes the regulatory clearance of a medical device (ER-REBOA™ Catheter) through the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to establish new safety and effectiveness claims.

Therefore, the document does not contain the detailed information you're asking for regarding acceptance criteria, specific study design elements (like sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance). This type of information is typically found in full clinical study reports, scientific publications, or de novo submission summaries, which are not provided here for this 510(k) clearance.

Here's what can be extracted and what cannot:

What the document does provide:

• Device Name: ER-REBOA™ Catheter
• Purpose of Clinical Data: To demonstrate substantially equivalent safety and effectiveness compared to the predicate device when used as labeled, particularly regarding the added specific indication for "patients requiring emergency control of hemorrhage."
• Type of Clinical Data:
  1. Real-world clinical data from the American Association for the Surgery of Trauma Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry (prospective).
  2. A case series report of ER-REBOA™ Catheter use in an austere military environment.
• Outcome Measured: Successful aortic occlusion.
• Reported Performance:
  • Successful aortic occlusion: 95.7% in the AORTA registry, 100% in the case series.
  • No instances of extremity ischemia, distal embolism, or retroperitoneal hemorrhage as complications of the device.

What the document does not provide (and why):

Since this is a 510(k) submission and not a de novo or PMA application with a dedicated clinical trial to establish new performance metrics for a novel technology (like an AI algorithm), the detailed information about acceptance criteria for an AI device, sample sizes for training/test sets, ground truth methodology, expert qualifications, or MRMC studies is not applicable and therefore not present in this document.

The "acceptance criteria" discussed in the document relate to the shelf life extension and demonstrating that the device adheres to the same acceptance criteria used in the original 510(k) after aging equivalent to 3 years (non-clinical testing). For clinical performance, the criterion is essentially "substantial equivalence" to the predicate, supported by the observed success rates and lack of complications.

If this were an AI device, here's how the provided information would map (and what's missing):

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

• Acceptance Criteria: Not explicitly stated as quantifiable thresholds for an AI device's specific performance metrics (e.g., "sensitivity ≥ 90%, specificity ≥ 80%"). Instead, the document frames "acceptance" around substantial equivalence and previous 510(k) criteria for device functionality and safety.
• Reported Device Performance:
  • Successful aortic occlusion: 95.7% (AORTA registry), 100% (case series).
  • Complications (extremity ischemia, distal embolism, retroperitoneal hemorrhage): 0%
  • This is performance for the catheter itself in its intended use, not an AI's diagnostic performance.

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

• Test Set Description:
  • AORTA Registry: Prospectively identified trauma patients requiring aortic occlusion from eight ACS Level 1 centers.
  • Case Series: ER-REBOA™ Catheter use in an austere military environment.
• Sample Size (Number of Cases): Not explicitly stated, just that 27.7% of placements in the registry were without medical imaging and 68.1% with plain x-ray, and all case series placements were without medical imaging. This implies a number of patients, but the exact count isn't provided.
• Data Provenance: USA (AORTA registry), unspecified "austere military environment."
• Retrospective/Prospective: AORTA registry is prospective; case series is likely retrospective reporting, though it's not explicitly stated.

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

• Not applicable/Not mentioned. This information is for AI algorithm validation where expert consensus might define the "correct" diagnosis or finding. Here, the "ground truth" for the catheter's performance is whether it successfully occluded the aorta as determined by the treating clinicians in a real-world setting.

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

• Not applicable/Not mentioned. This pertains to how disagreements among expert readers are resolved for AI ground truth.

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, not done/not mentioned. This is specific to AI-assisted reading.

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

• Not applicable/Not mentioned. The device itself is a physical catheter, not a standalone AI algorithm.

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

• Outcomes Data: The "successful aortic occlusion" and "no complications" are based on clinical outcomes observed by the treating medical staff.

8. The sample size for the training set

• Not applicable/Not mentioned. There is no AI algorithm being trained.

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

• Not applicable/Not mentioned. There is no AI algorithm being trained.

In summary, this document is for a medical device (catheter) clearance and therefore lacks the detailed AI-specific validation information you're seeking.

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