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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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The ER-REBOA Catheter is intended for temporary occlusion of large vessels and monitoring of blood pressure.

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 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 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 catheters two lumens. The peel-away sheath can be separated from the catheter shaft after insertion if needed.

The provided text describes the ER-REBOA™ Catheter and its substantial equivalence to predicate devices, supported by performance testing. However, it does not include acceptance criteria or specific detailed results in a format that would allow for a direct comparison table of acceptance criteria vs. reported device performance. It also lacks granular details about study methodology such as sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case studies, which are typically found in detailed study reports rather than a 510(k) summary.

Therefore, I cannot directly fulfill all your requests comprehensively based only on the provided input. I will extract and infer what I can from the given text and indicate where information is missing.

Here's an attempt to answer your request based on the provided document:

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

The document lists "Performance bench and in vivo (animal) testing" as having been performed to support safety and effectiveness, and concludes that "The results of these tests demonstrate that the ER-REBOA™ Catheter has been designed and tested to conform to its intended use and comparably to the predicate devices." However, specific numerical acceptance criteria for these tests and the reported device performance values themselves are not provided in this 510(k) summary. The document only lists the types of tests conducted.

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

• Sample Size for Test Set: Not explicitly stated for any of the in vitro bench tests or the in vivo animal study. The in vivo study mentions "an Acute Naïve Porcine" but does not specify the number of animals.
• Data Provenance: The in vivo study was "Performance Evaluation of the ER-REBOA™ Catheter in the Aorta of an Acute Naïve Porcine." This is an animal study, not human clinical data. The location or specific institution where these tests were performed is not provided. All tests would be considered prospective as they were specifically conducted for the device's evaluation.

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)

This information is not provided in the document. The tests performed are primarily engineering and animal studies, which typically do not involve establishing "ground truth" through expert consensus in the same way as, for example, diagnostic imaging interpretation.

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

This information is not provided and is generally not applicable to the types of bench and animal tests described.

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 conducted or described. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiology AI), which is not the nature of the ER-REBOA Catheter.

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

Not applicable. The ER-REBOA Catheter is a physical medical device (a catheter), not an algorithm or AI system. Its performance is inherent to the device itself, not an algorithm's output.

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

For the in vitro tests, "ground truth" would be established by validated measurement techniques and scientific principles (e.g., specific pressure readings, dimensional measurements, material properties). For the in vivo animal study, "ground truth" would be physiological measurements (e.g., blood pressure, vessel occlusion confirmation) obtained directly in the animal model. No expert consensus, pathology, or human outcomes data are mentioned as ground truth sources.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device, not an AI/ML algorithm.

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