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Equalizer™ Occlusion Balloon Catheter is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.

Any use for procedures other than those indicated in the instructions is not recommended.

The Equalizer™ Occlusion Balloon Catheter is constructed of a soft compliant latex balloon mounted near the tip of a dual-lumen nylon catheter shaft. Radiopaque markers are placed adjacent to the balloon to provide visual reference points for balloon positioning within the vessel. The catheter shaft is radiopaque, maximizing fluoroscopic visibility. Proximal to the bifurcation, the two lumens of the catheter are marked to differentiate their use. The tubing marked 'BALLOON' is the balloon inflation lumen. The tubing marked 'DISTAL' is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The lumen can also be used for the infusion of contrast media or therapeutic drugs. Each lumen ends in a luer fitting hub for attachment to ancillary devices.

The provided K140273 510(k) Summary describes a medical device, the Equalizer™ Occlusion Balloon Catheter, and its performance evaluation. However, it does not involve an AI/ML device, and therefore several of the requested categories are not applicable. The study primarily relies on bench testing and biocompatibility testing rather than clinical performance data related to diagnostic accuracy or AI model performance.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document primarily states that testing was performed to "support a determination of substantial equivalence" and provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria are not detailed in this summary for each test, but they would typically reference established industry standards (e.g., ISO for biocompatibility) or internal specifications benchmarked against the predicate device (Equalizer™ Occlusion Balloon Catheter K021721).

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

The study described is bench testing and biocompatibility testing, not a clinical study involving human data. Therefore:

• Sample Size for Test Set: Not specified in terms of human subjects or clinical cases. For bench tests, it would refer to the number of devices or components tested. For biocompatibility, it refers to the samples tested in vitro or in animal models (though details are not provided).
• Data Provenance: Not applicable as it's not clinical data. The tests were performed in a laboratory setting, likely at the manufacturer's facilities or a contract research organization.

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. This device is a physical medical device (catheter), and its performance evaluation involves engineering and biocompatibility testing, not interpretation of medical images or diagnostic outputs for which ground truth would be established by medical experts.

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

Not applicable. Adjudication methods are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth, which is not relevant for bench and biocompatibility testing of a physical device.

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 is not an AI/ML device and no MRMC study was performed.

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

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

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

The concept of "ground truth" as typically applied to diagnostic AI/ML devices is not directly applicable here. Instead, the "ground truth" for this device's performance can be considered:

• Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) define acceptable biological responses.
• Engineering Specifications: Predetermined design specifications and performance requirements (e.g., burst pressure, inflation time, tensile strength) established by the manufacturer and benchmarked against the predicate device.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Equalizer™ Occlusion Balloon Catheter K021721) served as the reference for establishing substantial equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML component; therefore, no training set is relevant.

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

Not applicable. There is no AI/ML component; therefore, no ground truth for a training set was established.

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The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.

The provided text describes a 510(k) summary for the SentreHeart Occlusion Balloon Catheter. However, it does not contain specific details about acceptance criteria for performance, device performance data through a study, sample sizes for testing, ground truth establishment, or human-in-the-loop studies.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that functional testing and biocompatibility testing were performed but does not quantify the acceptance criteria or the results against those criteria. It relies on a general statement of "safe and effective" and "biocompatible."

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

Missing Information: The document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "functional testing" is broadly mentioned without any details.

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

Missing Information: Since no specific test set or clinical study is detailed, there is no mention of experts or how ground truth would have been established. This device is a catheter, not an AI/diagnostic imaging device where expert interpretation is typically a primary ground truth.

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

Missing Information: No information provided.

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

Missing Information: This is not applicable to a device like an "Occlusion Balloon Catheter." MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This is a medical device for temporary occlusion, not a diagnostic tool assisted by AI.

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

Missing Information: This is not applicable. The device is a physical catheter, not an algorithm.

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

Missing Information: For a medical device like this, "ground truth" would typically relate to the physical and mechanical properties of the device (e.g., balloon inflation pressure, burst pressure, material strength, biocompatibility results) and its ability to achieve its intended function (occlusion) in relevant models (in vitro, animal, or human studies, though clinical efficacy data isn't detailed here for the 510(k)). The document only generally refers to "functional testing."

8. The sample size for the training set

Missing Information: Not applicable. This is not an AI/machine learning device that requires a training set.

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

Missing Information: Not applicable.

Summary of the Study Mentioned in the Document:

The document briefly mentions:

• "Functional testing": Conducted to support substantial equivalence and demonstrate safety and effectiveness.
• "Biocompatibility testing": Conducted for the materials used in the catheter.

Key takeaway: This 510(k) summary is for a medical device (a catheter), not a software or AI-based diagnostic tool. Therefore, many of the requested categories (like ground truth from experts, MRMC studies, training sets, algorithms) are not applicable. The document itself provides a very high-level summary of testing without specific quantitative performance data or detailed study designs. It relies on the concept of "substantial equivalence" to predicate devices rather than novel, extensive performance studies with detailed acceptance criteria for statistical clinical endpoints.

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