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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:

1. 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.
2. Sample sized used for the test set and the data provenance: Not provided in the document.
3. 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.
4. Adjudication method for the test set: Not applicable or not provided.
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 is not an AI diagnostic device for human interpretation.
6. 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.
7. 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.
8. 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.
9. How the ground truth for the training set was established: Not applicable.

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The CryoSeal® FS Applicator System is intended for the simultaneous application of the two components of CryoSeal FS (fibrin sealant) onto the incised liver surface in patients undergoing liver resection.

The CryoSeal® FS Applicator System is composed of a thermoplastic polystyrene applicator handle, and two types of dispensing tips with a Y-body manifolds for application of the fibrin sealant: line/drop tips (5 and 10 cm lengths) and spray tips (3 configurations).

The provided text is a 510(k) summary for the CryoSeal® FS Applicator System. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, study details, or performance data to prove the device meets such criteria.

The document primarily focuses on the regulatory submission process, including:

• Applicant and contact information
• Device trade name, classification, and product code
• Predicate devices
• Statement of intended use
• Device description
• Comparison to predicate devices
• The FDA's decision letter confirming substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided text.

The 510(k) summary states that "This device, with respect to material composition, device characteristics, principles of operation, and intended use, is substantially equivalent to the predicate devices." This implies that the device's performance is considered equivalent to already approved devices, but specific performance criteria and the studies demonstrating them are not detailed here.

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ThermoGenesis Applicators and Applicator Tips are intended to deliver two solutions simultaneously to a medical or surgical site This products are supplied sterile and are intended for single patient use.

The ThermoGenesis Applicator product line consists of two devices: (1) a drop applicator with various straight, angled and flexible dual cannulated applicator tips, and (2) a spray application device with tip. All configurations of these products allow the user to deliver two solutions using one hand. All configurations of the devices are only intended for simultaneous application of two solutions and are specifically not intended for intravenous injection.

The provided text describes a medical device (ThermoGenesis Applicator) and its intended use, but it does not contain information about acceptance criteria, a study proving device performance, or any of the detailed study parameters requested in the prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number or qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

The document focuses on:

• Device classification and naming.
• Intended use (delivering two solutions simultaneously to a medical or surgical site).
• Description of the product lines (drop applicator, spray applicator).
• Statement of substantial equivalence to other liquid medication dispensers, asserting no new safety or effectiveness issues.

To answer your request, a document detailing actual performance testing, clinical studies, or engineering validation with specific acceptance criteria would be needed.

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