(57 days)
The AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow.
The AXP Platform MarrowXpress System is a semi-automated, closed system that harvests a precise, operator-determined volume of stem cell-rich buffy coat from human bone marrow. The system consists of the following major components 1) disposable Processing Bag Set, 2) rechargeable NiMH battery-powered MXP Device, 3) AC-powered Docking Station, and 4) XpressTRAK software. Accessories include a bar code scanner, weight kit, counterweight, and MXP Device stand. The AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow. The MXP Device separates the bone marrow aspirate into red blood cells, plasma, and buffy coat utilizing a standard laboratory centrifuge, and meters each of these components into a separate compartment within the disposable Processing Set. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. After processing, the MXP Device is placed into the AC powered Docking Station. The Docking Station automatically downloads processing data into the XpressTRAK software and recharges the MXP Device battery pack. The following information is communicated to the XpressTRAK software via a serial connection: MXP Device serial number, errors detected during processing, duration of processing, g force during processing, and mass calculation data. The XpressTRAK application software manages and stores the bone marrow processing data, verifies operational status of the system, and has report production capabilities. The software permits the user to search and sort collected data using the following fields: centrifuge ID, bone marrow aspirate unit number, Processing Bag Set lot number, buffy coat volume, user-definable fields, user name, or date and time.
The provided document is a 510(k) premarket notification for the AXP Platform MarrowXpress™ System. It discusses the device's substantial equivalence to a predicate device and its indications for use. However, it does not contain the detailed information necessary to answer the questions about acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement as requested.
The document states: "A comparison of device features and in-vitro test data (TNC, MNC, platelet and stem cell recovery, cell viability and concentrate hematocrit) demonstrate that the AXP Platform MarrowXpress System is substantially equivalent to the currently marketed Harvest Technologies SmartPReP2 Centrifyae System." This indicates that some form of in-vitro testing was performed, but the specifics of that testing (acceptance criteria, methodologies, sample sizes, etc.) are not present in the provided text.
Therefore, I cannot fill in the table or answer the specific questions based solely on the given information.
Based on the provided text, I can only state the following:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The document mentions "in-vitro test data (TNC, MNC, platelet and stem cell recovery, cell viability and concentrate hematocrit)" were used for comparison, but the acceptance criteria or specific performance values are not listed.
- Sample sized used for the test set and the data provenance: Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This device is a semi-automated system for processing bone marrow, not an AI diagnostic tool requiring expert interpretation for ground truth.
- Adjudication method for the test set: Not applicable or not provided.
- 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 is not an AI diagnostic device for human interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "semi-automated" and "algorithm only" performance is not explicitly discussed beyond its mechanical functions. The performance mentioned ("TNC, MNC, platelet and stem cell recovery, cell viability and concentrate hematocrit") would be standalone performance of the system's processing capabilities.
- The type of ground truth used: Not explicitly stated, but for "TNC, MNC, platelet and stem cell recovery, cell viability and concentrate hematocrit," the ground truth would typically be established through validated manual laboratory techniques (e.g., flow cytometry, hemocytometer counts) performed on the raw or processed samples.
- The sample size for the training set: Not applicable. This is not a machine learning model that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.