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The PerFuse Percutaneous Decompression System is intended to be used for the delivery of allograft, autograft, and synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate mixing and pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

The disposable instrument set is comprised of a sterile, sinqle-use disposable kit containing the stainless steel cannula, trocar rod, and plunger rod. The non-sterile stainless steel handle assembly consists of a reusable handle, slide hammer adapter, slide hammer, and strike cap. The handle assembly is organized in a stainless steel instrument case. All components are made of stainless steel. The strike cap threads onto the handle body and is designed to receive a mallet or hammer strike to drive the trocar point/cannula into bone tissue.

The handle is cannulated to allow the trocar rod to pass through the length of the handle and be contained within the strike cap. The cannula creates a 6.17mm bore diameter hole.

The cannula, trocar rod, and plunger rod all come in two lengths. The cannula is designed for use in accessing the femoral head. The smaller length is designed to access the humeral head. Each cannula has depth lines etched onto the surface to indicate the instrument depth to the operating surgeon. The cannula and plunger rod and/or syringe (syringe sold separately) are used to deliver blood components and/or bone graft material through the cannula to an orthopedic surgical site.

The gamma-sterilized components are supplied as single use disposables to ensure the cannula is free of debris and the trocar rod is sharp at the beginning of each procedure.

The document describes the PerFuse Percutaneous Decompression System, a device intended for delivering bone graft material to orthopedic surgical sites and facilitating the mixing of bone graft material with various blood components or fluids.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

• Cannula Luer Taper Load Test (Sealing under axial load): 18 syringes. Data provenance is not explicitly stated but implies laboratory testing, likely internal to the company.
• Cannula Luer Taper Load Test (Sealing without axial restraint): 18 syringes. Data provenance is not explicitly stated but implies laboratory testing, likely internal to the company.
• Instrument Integrity in a sawbones simulation: 6 cannula. Data provenance is not explicitly stated but implies laboratory testing using synthetic bone models (sawbones), likely internal.
• Instrument Cadaver Lab Verification Study: Six core decompression procedures. Data provenance is cadaveric subjects, conducted in a lab setting, likely internal.
• Delivery of hydrated graft through PerFuse and CDO cannulas: Not explicitly stated, but the "equivalence" suggests a comparative test between PerFuse and the predicate CDO system. Data provenance is implied to be laboratory bench testing, likely internal.

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

This information is not provided in the document. The studies described are non-clinical engineering and performance tests, not clinical efficacy or diagnostic accuracy studies that would typically involve expert ground truth.

4. Adjudication method for the test set:

This information is not applicable as the described studies are non-clinical bench and cadaver tests, not studies requiring adjudication of output from an automated system or human readers.

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 MRMC comparative effectiveness study was done. This device is a medical instrument for delivering materials, not an AI-powered diagnostic or assistive tool.

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

This is not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used:

The ground truth for these non-clinical tests was based on objective measurements and observations of mechanical properties, seal integrity, penetration depth, successful procedure completion in a cadaver, and volume of material delivered. For the Cadaver Lab Verification Study, "successful procedures" would have been determined by the operating surgeon(s) or qualified personnel conducting the study.

8. The sample size for the training set:

Not applicable. This device is a physical instrument, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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