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The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or vein after catheterization.

The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connection tubing and belt. The device is applied on the patient with the dome over the femoral artery or vein and the belt around the patient. A sterile wound dressing is to be placed between the device and the patient making the device a "non-patient contacting device". The user controls the inflation of the dome by increasing or decreasing the pressure with a connected, manual pump (not provided). The dome applies a mechanical pressure over the spot where there is bleeding, while the arch and belt absorb and evenly distribute the opposite force from the dome. Only the femoral compression device is the subject of this submission; the integrated pump with a manometer is not included in the scope of this submission.

While the provided text describes the regulatory submission for a reprocessed femoral compression device (K120204), it does not include detailed information about acceptance criteria or specific study data to prove the device meets those criteria in the typical format of a clinical or performance study report.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of conducting new effectiveness studies to define and meet specific performance acceptance criteria for an entirely novel device, the manufacturer (SterilMed, Inc.) primarily relies on established performance characteristics of already-approved predicate devices.

Therefore, I cannot populate all sections of your request as if this were a clinical study. However, I can extract the relevant information from the provided document regarding the types of testing performed and the overall conclusion.

Here's how I'll address your request based on the provided document:

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

Since specific quantitative acceptance criteria or detailed device performance metrics are not explicitly stated in this 510(k) summary, I will infer the "acceptance criteria" from the types of tests performed and the "reported device performance" from the summary of test conclusions.

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 specified for individual tests. The document states "Representative samples of reprocessed femoral compression devices were tested." This is common in a 510(k) where the focus is on process validation and demonstrating equivalence, rather than a clinical trial with a specific patient cohort sample size.
• Data Provenance: Not specified. This would typically be internal company testing and validation data, likely conducted in the US (Minnesota, where SterilMed is located).
• Retrospective/Prospective: The testing described (cleaning, sterilization, functional performance, etc.) would be considered prospective as it involves creating and testing samples specifically for this regulatory submission.

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 is not a study involving expert assessment or interpretation (like an AI study might entail). The "ground truth" here is compliance with validated engineering and biological safety standards.

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

Not applicable. There is no expert adjudication process described, as the tests are objective laboratory and bench tests against defined standards.

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 document is for a medical device (a reprocessed compression device), not an AI diagnostic tool that would involve human readers.

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

This is not applicable, as it is a physical medical device, not an algorithm.

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

The "ground truth" in this context is based on:

• Validated Standards: Compliance with established international and US standards (e.g., ISO 11135, USP , ISO 10993-1, ISO 10993-7, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096, ASTM 1980-07) for cleaning, sterilization, biocompatibility, packaging, and shelf life.
• Functional Specifications: Meeting predefined functional specifications through bench testing, visual inspection, simulated use, and fatigue testing.
• Predicate Device Performance: The underlying assumption is that the predicate devices (SterilMed Femoral Compression Device K012574 and St. Jude Medical FemoStop™ Gold Femoral Compression System K080206) have already demonstrated safety and effectiveness, and the reprocessed device matches those characteristics.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm; therefore, there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

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The reprocessed femoral compression device is intended for use in the compression of the femoral artery or vein after catheterization.

Reprocessed Femoral Compression Device

This document is a 510(k) premarket notification for a reprocessed femoral compression device. It details the device, its intended use, and claims of substantial equivalence to an existing device. However, it does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment relevant to the questions provided. The document is a regulatory submission for market clearance, not a study report detailing performance metrics.

Therefore, I cannot answer the questions based on the provided text. The requested information on acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not present in this regulatory submission.

Ask a specific question about this device