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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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