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The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

The HemoCath II is radiopaque silicone, comprised of 2 single lumens used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focused on the HemoCath II device:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. The submission states, "Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for hemodialysis and apheresis treatments." The testing involved in vitro performance data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical data or expert-based ground truth was established for a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical data or expert-based ground truth was established for a test set.

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: Not applicable. This device is a medical catheter and not an AI-driven diagnostic or assistive tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter and does not involve an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance was established by comparison to the performance of legally marketed predicate devices through in vitro testing. There was no clinical ground truth established for this submission.

7. The sample size for the training set: Not applicable. There was no "training set" in the context of an AI/ML algorithm. The comparison was made against existing predicate device performance.

8. How the ground truth for the training set was established: Not applicable. The device is not an AI/ML algorithm requiring a training set with established ground truth. Its safety and efficacy were demonstrated by comparing its in vitro performance characteristics (flow rate, tensile strength) to those of already legally marketed predicate devices.

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The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.

The PD Cath is a radiopaque silicone, single lumen catheter used to insert and remove peritoneal fluid. The fixed Dacron cuff allows for tissue ingrowth for long-term placement. A flexible silicone overtube is permanently bonded to the lumen passages and the cuff to insulate the cuff from forces applied to the external or internal lumens.

The provided text is for a 510(k) premarket notification for a medical device called "PD Cath." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish safety and efficacy from scratch.

Therefore, the information typically requested in your prompt (such as acceptance criteria tables, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and extensive training set details) is generally not applicable to a 510(k) submission for a device like the PD Cath, which is a relatively low-risk device without complex diagnostic algorithms or image analysis components.

Here's a breakdown based on the provided document:

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

• Acceptance Criteria: The document directly states that "Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for peritoneal dialysis." The acceptance criteria are implicitly tied to demonstrating substantial equivalence in performance characteristics to the predicate devices, specifically in terms of flow rate and tensile strength. The exact numerical acceptance criteria are not specified in the public summary.
• Reported Device Performance:

  Performance Metric	Reported Device Performance (PD Cath)	Predicate Device (Dermaport™ Access Device - K894131, Missouri Catheter - K874650)
  Flow Rate	Substantially equivalent	Data not provided, but inferred to be similar to legally marketed devices
  Tensile Strength	Substantially equivalent	Data not provided, but inferred to be similar to legally marketed devices

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

• Sample Size: Not applicable. No clinical test set data was used. The performance testing was in vitro.
• Data Provenance: Not applicable. In vitro testing was conducted, not clinical data from patients.

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. No clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

• Not applicable. No clinical test set requiring adjudication was performed.

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 device is a physical catheter, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable for the reasons mentioned above. The "ground truth" for this submission was the established performance characteristics of the legally marketed predicate devices, against which the in vitro performance of the PD Cath was compared.

8. The sample size for the training set

• Not applicable. No AI/machine learning training set was used.

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

• Not applicable. No AI/machine learning training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was an in vitro performance test demonstrating that the PD Cath's flow rate and tensile strength were "substantially equivalent" to legally marketed predicate devices (Dermaport™ Access Device -- K894131 and Missouri Catheter-K874650). The FDA determined that clinical data was not necessary for this substantial equivalence determination. The specific details of the in vitro testing methodology, raw data, and precise quantitative equivalence metrics are not provided in this public summary, as is typical for 510(k) summaries. The acceptance criteria were met by showing that the physical characteristics (flow rate, tensile strength) of the PD Cath were comparable to established, safe, and effective peritoneal dialysis catheters already on the market.

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The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

The HemoCath is a radiopaque silicone, double lumen catheter used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) summary for a medical device (HemoCath Hemodialysis/Apheresis Catheter) seeking clearance from the FDA. It does not describe an "AI device" or a study in the typical sense of evaluating software performance with AI. Instead, it describes a medical device undergoing a regulatory review process for substantial equivalence to existing legally marketed devices. Therefore, many of the requested fields related to AI, software performance, expert reviews, ground truth, and training sets are explicitly not applicable.

Here's the information extracted and contextualized:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goal: To demonstrate substantial equivalence to legally marketed predicate devices in terms of performance. The specific performance criteria for central venous catheters (like flow rate and tensile strength) are implied to be met.

Study that Proves the Device Meets the Acceptance Criteria:

The document explicitly states that "Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for hemodialysis and apheresis treatments."

Therefore, the "study" was an in vitro performance study.

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

• Sample Size for Test Set: Not specified in the 510(k) summary. For in vitro testing of a physical device like a catheter, the sample size would typically refer to the number of catheters tested for each metric (e.g., X number of catheters for flow rate, Y for tensile strength). This level of detail is usually found in the full 510(k) submission, not the summary.
• Data Provenance: The data is from in vitro testing. It does not involve human subjects or retrospective/prospective collection of patient data. Therefore, country of origin is not applicable in the patient data sense; the testing would have been conducted by the manufacturer or a contract lab.

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

• Not applicable. This was an in vitro engineering/performance test, not a study requiring expert clinical review or interpretation of patient data to establish ground truth. The "ground truth" here would be objective physical measurements of the catheter's performance against established engineering standards or predicate device performance.

4. Adjudication Method for the Test Set

• Not applicable. There was no human interpretation or subjective assessment of the test set data that would require an adjudication method. The results were objective measurements (e.g., flow rate in ml/min, tensile strength in N).

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, an MRMC comparative effectiveness study was not done. This is a physical medical device (catheter), not an AI algorithm, and therefore this type of study is not relevant.

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

• Objective physical measurements and engineering standards.
  • For flow rate: Measurements of fluid volume over time.
  • For tensile strength: Measurements of force at which the catheter breaks.
  • Comparison was made against the performance of legally marketed predicate devices (DermaPort™ Access Device and RetrO™ Catheter) and likely against relevant international or industry standards for such devices.

8. The Sample Size for the Training Set

• Not applicable. This pertains to a physical medical device developed through engineering and manufacturing processes, not an AI algorithm that requires a training set.

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

• Not applicable. As above, no training set was used for an AI algorithm. The "ground truth" in the context of developing this catheter would involve engineering specifications, materials science data, and performance characteristics derived from predicate devices and industry standards.

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