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Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by invitro testing. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Decathlon Gold, Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Gold. Coated catheters are fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated). The distal ends of this catheter have the arterial and venous tips rounded and "funneled" for easier over the wire insertion. It has one elliptical side hole placed on the distal ends of the arterial and venous lumens. A stylet will be preloaded in the arterial lumen for ease of guidewire placement.

The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.

The provided text describes a 510(k) summary for a medical device, the 15.5Fr Decathlon Gold, Coated Catheters with funnel tips. However, it does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study.

The document focuses on:

• Device Description: Details about the catheter's design, material (polyurethane with Carmeda® BioActive Surface (CBAS®) coating), and the "funneled" distal tips.
• Product Claims:
  • Maintains heparin's bioactive properties for a minimum of 90 days (demonstrated in two in-vitro studies).
  • Coating reduces total thrombus accumulation by 51% compared to uncoated catheters (demonstrated in an in-vitro thromboresistance study).
• Technological Characteristics Comparison to Predicate Devices: States that the device is identical to a predicate device (K060155) in materials, dimensions, and coating, with the only difference being the funneled distal tips.
• Performance Data: Refers to in-vitro blood loop testing and catheter flow bench testing as additional tests performed specifically for this device (Decathlon Gold with funnel tips), while other tests (stability, durability, mechanical properties) were performed on the predicate device and not duplicated.
• Predicate Devices: Lists several legally marketed devices that use the same Carmeda® BioActive Surface (CBAS®) coating.

Based on the provided text, I cannot answer the specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI assistance, sample sizes for training/test sets, ground truth establishment, or multi-reader multi-case studies.

The "studies" mentioned are in-vitro studies demonstrating the coating's properties (bioactivity duration, thrombus reduction) and do not involve human readers, AI, or clinical outcomes that would typically have acceptance criteria in the format requested. The document does not provide a table of acceptance criteria or specific performance against such criteria.

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The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.

The design of the CAPIOX® Cardiotomy Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. The total capacity of the reservoir is 1000 mL. The cardiotomy section of the CAPIOX® Cardiotomy Reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

Here's a breakdown of the acceptance criteria and the study information for the CAPIOX® Cardiotomy Reservoir, based on the provided text:

Summary of Acceptance Criteria and Device Performance

The device's acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to predicate devices. This means that its performance must be comparable to, and not raise new questions of safety or effectiveness compared to, established devices already on the market. The study aims to prove this equivalence.

• Pressure Drop Cardiotomy Section:
• Filtration Efficiency Cardiotomy Section:
• Effects Upon Cellular Blood Components:
• Pressure Integrity Testing:
• Tubing Connection Strength:
• Filter Breakthrough Time:
  (Detailed results for these specific tests are not provided in the text, only that the tests were conducted.) |

Study Details:

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

   • Sample Size: Not explicitly stated. The document refers to "comparative studies" and "tests were conducted" without providing specific numbers of devices or test runs. Given the nature of medical device testing (e.g., sterilization, biocompatibility, mechanical performance), it would involve a sufficient number of units to ensure statistical validity and representativeness, but the exact count is not given.
   • Data Provenance: Not explicitly stated. However, given that Terumo Cardiovascular Systems (a US-based company) is submitting a 510(k) to the FDA, it is highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The testing appears to be prospective in nature, as it was conducted specifically to demonstrate equivalence for this new device submission.

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

   • This type of device (a cardiotomy reservoir) does not typically involve expert consensus for "ground truth" in the way a diagnostic AI algorithm might. The "ground truth" for its performance is established through objective engineering and biological tests (e.g., measuring filtration efficiency, pressure drop, cellular damage, sterility, biocompatibility) against predetermined specifications or established predicate device performance.
   • Therefore, no information on the number or qualifications of experts establishing "ground truth" in this context is provided or relevant. The "ground truth" comes from the physical and chemical properties of the device and its interaction with blood.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading by radiologists) used to establish ground truth for AI algorithms. For medical devices like this, the performance is measured objectively through assays and tests, not subjective expert judgment.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The CAPIOX® Cardiotomy Reservoir is mechanical blood processing device, and its evaluation does not involve human "readers" or diagnostic tasks that would benefit from such a study.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Not applicable. This device is not an algorithm or AI system. Its performance is inherently standalone in the sense that it functions physically and biologically without human "input" for its core operation (processing blood). The "standalone performance" is what the various engineering and biological tests were designed to assess.

6. Type of Ground Truth Used:

   • The "ground truth" is based on objective measurements, laboratory test results, and established standards. This includes:
     • Biocompatibility test results: Against ISO 10993 standards.
     • Sterilization validation: Against AAMI guidelines for SAL.
     • Physical performance measurements: Such as filtration efficiency, pressure drop, pressure integrity, tubing connection strength, and filter breakthrough time, benchmarked against predicate devices.
     • Cellular effects: Assessment of impact on blood components.

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set." The device itself is manufactured, and its performance is evaluated, not "trained."

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

   • Not applicable, as there is no training set for a mechanical medical device like this.

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