Search Results

The Progenikine Concentrating System is used in medical procedures involving the harvesting of autologous adipose tissue. The Progenikine® Concentrating System is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Progenikine Concentrating System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.

Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.

Not Found

This document is a 510(k) clearance letter for a medical device (Progenikine Concentrating System). It does not contain any information about acceptance criteria, device performance data, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), MRMC studies, or standalone algorithm performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It primarily addresses regulatory aspects such as registration, listing, labeling, manufacturing practices, and adverse event reporting.

Therefore, it is not possible to extract the requested information (acceptance criteria, study details, etc.) from the provided text. This document is a regulatory approval notice, not a study report.

Ask a specific question about this device

The PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "PureBMC SupraPhysiologic Concentrating System." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a clearance letter, not a study report.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed information provided by the manufacturer (EmCyte Corporation) and determined that the new device is as safe and effective as existing devices on the market for its stated "Indications for Use."

The "Indications for Use" section (page 3) specifies:

"The PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established."

Key points from the document regarding the device and its clearance:

• Device Name: PureBMC SupraPhysiologic Concentrating System (available in 30 mL, 60 mL, and 120 mL systems).
• Intended Use: Preparation of platelet concentrate from bone marrow aspirate in a clinical laboratory or intraoperatively.
• Regulatory Status: Cleared via 510(k) as substantially equivalent to predicate devices.
• Regulatory Class: Class I.
• Limitations: The FDA explicitly states that "The safety and effectiveness of this device for in vivo indications for use has not been established." This is a crucial labeling limitation.

Therefore, I cannot provide the requested information because the provided document is an FDA clearance letter and not a study report containing acceptance criteria and performance data from a specific study.

The information requested in your prompt (Tables of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) is typically found in pre-market submission documents (like the 510(k) summary or detailed study reports) that would have been reviewed by the FDA, rather than the clearance letter itself.

Ask a specific question about this device