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The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheters are indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required. Catheters greater than 40cm in length are intended for femoral vein insertion.

The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter is manufactured from soft radiopaque polyurethane material which provides increased patient comfort while providing excellent biocompatibility. The Hemodialysis Catheter can be connected to an extracorporeal tubing system via a connecting tube equipped with a Luer-Lock connector. The proximal lumen (red clamp) provides "arterial" blood outflow from the patient, the distal lumen (blue clamp) provides "venous" blood return to the patient. Important information such as priming volume and catheter length is printed on both sides of the clamp. The catheter comes in a variety of sizes and lengths with straight or curved extensions.

The provided text describes a medical device called the "NovoFlo Catheter LT Dual Lumen Long Term Hemodialysis Catheter" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance metrics, or a study that uses statistical analysis with human readers or standalone algorithm performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data as might be found in a PMA (Premarket Approval) submission or detailed clinical trial reports.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance thresholds (e.g., sensitivity, specificity, accuracy). The acceptance criteria were based on demonstrating substantial equivalence to the predicate device in terms of design, materials, performance, biocompatibility, safety, and product effectiveness.
• Reported Device Performance: No specific quantitative performance metrics (e.g., flow rates, complication rates, longevity) are reported for the NovoFlo™ Catheter itself. The document states there are "no major differences in design, materials, performance, biocompatibility, safety and product effectiveness" compared to the predicate device.

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

• Not applicable. This device is not an AI/diagnostic device that uses a "test set" of patient data in the computational sense. The "tests" mentioned are engineering studies and biocompatibility tests. No human patient data test set is described.

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

• Not applicable. No "ground truth" establishment by experts on a test set is described.

4. Adjudication method for the test set:

• Not applicable. No test set adjudication is 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:

• Not applicable. This is not an AI device, and no MRMC study is mentioned.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of diagnostic/AI performance studies. The "ground truth" for the device's substantial equivalence likely refers to established industry standards (ISO, FDA guidances) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable.

Summary based on provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. The provided document details a 510(k) submission for a physical medical device, not a diagnostic algorithm. The "tests" were engineering studies and biocompatibility evaluations, not clinical studies with patient data test sets.

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

• Not applicable. No "ground truth" involving expert consensus on patient data is mentioned.

4. Adjudication method 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:

• Not applicable. This is not an AI 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 a physical medical device.

7. The type of ground truth used:

• For the purpose of the 510(k) submission, the "ground truth" was the established characteristics and performance of the legally marketed predicate device (Medcomp Hemo-Flow Catheter), as well as adherence to recognized industry standards (ISO 10555, ISO 10993) and FDA guidance documents.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable.

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THE MEDCOMP EXCELL™ SPLIT-TIP CATHETER IS INDICATED FOR USE IN ATTAINING LONG TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

The Medcomp Excell™ Split-Tip Catheter is a 15F polyurethane, double lumen catheter used to remove and return blood through two, segregated furnen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long-term placement. The arterial and venous lumens now are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the I.D. rings for ease in identification.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp Excell™ Split-Tip Catheter:

Acceptance Criteria and Device Performance

The provided document describes the modification of a legally marketed device and asserts its substantial equivalence to predicate devices. The "acceptance criteria" are implied by the performance data demonstrating "substantial equivalence." However, explicit, quantifiable acceptance criteria with pass/fail thresholds are not stated in the document.

The performance data focuses on demonstrating that the modified device performs similarly to existing, legally marketed devices for hemodialysis and apheresis treatments.

Here's a table based on the provided information:

Note regarding "Acceptance Criteria": The document does not explicitly list quantified acceptance criteria (e.g., "recirculation must be less than 5%"). Instead, it states that the device was tested to demonstrate "substantial equivalence" to predicate devices for specific performance characteristics. This implies that the acceptance criteria were met if the device's performance in these tests was comparable to that of the predicate devices, falling within an acceptable range for the intended use.

Study Details (Based on the provided text)

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

   • Sample Size: Not specified. The study involved "in vitro performance data," which typically refers to laboratory testing and might involve multiple samples of the device, but the exact number is not provided.
   • Data Provenance: The study was an in vitro performance test, meaning it was conducted in a laboratory setting, not on human subjects. The country of origin for the data is not explicitly mentioned, but the submitter is a U.S. company (Harleysville, PA). It is by definition a prospective study in that the testing was performed on the device designed for submission.

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

   • Number of Experts: Not applicable. This was an in vitro performance study comparing the device to predicate devices. There was no "ground truth" established by human experts in the context of clinical observations or diagnoses. Instead, the performance parameters of the device were measured and compared.
   • Qualifications of Experts: Not applicable for establishing ground truth.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. As an in vitro performance study, there was no need for expert adjudication of results in the way it would be required for clinical image analysis or diagnostic studies. The results were likely derived from standardized test protocols and measurements.

4. 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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a medical catheter, not an AI software intended for interpretation by human readers.
   • Effect Size of AI assistance: Not applicable.

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

   • Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance for an algorithm doesn't apply. The in vitro testing represents the "standalone" performance of the physical device in a controlled environment.

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

   • Type of Ground Truth: Not applicable in the traditional sense of clinical "ground truth." For in vitro performance studies, the "ground truth" is typically defined by standardized physical measurements, engineering specifications, and the established performance characteristics of the predicate devices. The "truth" is that the device should perform comparably to its predicates under controlled test conditions.

7. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for the device itself.

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

   • Ground Truth for Training Set: Not applicable for the reasons stated above (physical device, no machine learning model).

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