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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.

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The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

The SmartPReP Centrifuge System is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood.

Not Found

Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a medical device (SmartPReP2 Centrifuge System and SmartPReP Centrifuge System).

This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance.

It does NOT contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, expert involvement, and ground truth establishment.

The document focuses on:

• Device name and intended use.
• Regulatory classification.
• Reference to the predicate device.
• General regulatory requirements for the manufacturer.

To answer your questions, you would typically need to refer to a detailed study report, a scientific publication, or the actual 510(k) submission document itself (which often includes more detailed performance data and study summaries, though not always in the exact format you're looking for).

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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 MarrowStim™ Concentration Kit and the MarrowStim™ Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

The MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit consist of a table-top, swinging bucket centrifuge and accessories to allow for preparation of platelet poor plasma and platelet concentrate from blood, and for preparation of a cell concentrate from bone marrow.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit, which are centrifuges. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Harvest SmartPReP2 Centrifuge System, K052925) rather than presenting new performance study data with specific acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

• "Documentation is provided which demonstrated the · MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit to be substantially equivalent to other legally marketed devices."
• This indicates that direct comparative performance studies against acceptance criteria for the new device were likely not the primary method of clearance, but rather a comparison to an existing, cleared device.

The FDA letter also includes a warning:

• "The safety and effectiveness of this device for in vivo indications for use has not been established." This further confirms that no clinical studies proving safety and effectiveness for in vivo use were part of this submission.

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The GenesisCS Component 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 plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. 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) premarket notification decision letter from the FDA for the GenesisCS Component Concentrating System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Here's why and what's typically found in such documents when performance data is included:

• 510(k) Premarket Notification: This type of submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trial data demonstrating novel safety and effectiveness.
• "Substantial Equivalence": The FDA determines if a new device is as safe and effective as a predicate device, often by comparing intended use, technological characteristics, and performance data if relevant differences exist. However, comprehensive performance studies with acceptance criteria are not always fully detailed in the publicly available decision letter itself, but rather in the submitted 510(k) summary or full submission.
• Missing Information: The provided text is a regulatory clearance letter. It clearly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, I cannot provide the requested information based solely on the provided text. The document does not describe:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for a test set, data provenance, or details of retrospective/prospective studies.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

However, I can extract the following relevant information:

• Trade/Device Name: GenesisCS Component Concentrating System
• Regulation Number: 21 CFR 862.2050
• Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use
• Regulatory Class: Class I
• Product Code: JQC
• Intended Use Statement: "The GenesisCS Component 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 plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow."
• Important Warning/Limitation: "The safety and effectiveness of this device for in vivo indications for use has not been established." This indicates that while the device is cleared for its stated in vitro laboratory preparation uses, it has not been proven safe or effective for direct use within a living organism.

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The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

The Harvest Technologies SmartPReP2 System includes a table-top, self-decanting swinging bucket centrifuge. The SmartPReP2 Bone Marrow Procedure Pack includes a Process Disposable and other accessories to allow for separation of cells from bone marrow aspirate.

This document is a 510(k) premarket notification summary for the SmartPReP2 Centrifuge System. It describes the device and its intended use, indicating that it is substantially equivalent to a previously cleared device. However, it does not contain a detailed study with acceptance criteria and reported device performance in the way a clinical trial or a performance study for AI device would.

Therefore, most of the requested information cannot be extracted from this document, except for the following:

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

The document states: "Performance Testing: Results of biocompatibility and performance testing have established that the SmartPReP2 System is suitable for the intended use indicated." However, it does not provide specific acceptance criteria or quantitative performance results (e.g., in a table format) for aspects like platelet concentration efficiency, cell viability, or purity of separation which would typically be included for such a device. Without this information, a table cannot be constructed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is 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 (e.g. radiologist with 10 years of experience):

This information is not applicable and not provided. The device is a centrifuge system, not an AI diagnostic tool requiring expert ground truth establishment in this context.

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

This information is not applicable and 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:

This information is not applicable. The SmartPReP2 Centrifuge System is a medical device for preparing biological samples, not an AI system for diagnostic imaging or interpretation that would involve human readers.

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

This information is not applicable. The device is a centrifuge, not an algorithm.

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

This information is not applicable in the context of an AI device requiring ground truth. For a centrifuge, "ground truth" would be related to the accuracy and efficiency of its physical separation process, likely measured by laboratory tests on the processed samples (e.g., cell counts, viability assays), but these specific details are not provided in this summary.

8. The sample size for the training set:

This information is not applicable. The device is a centrifuge, not an AI system that undergoes "training."

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

This information is not applicable.

Summary of available information:

The document is a 510(k) summary focused on demonstrating "substantial equivalence" to a predicate device (SmartPReP Centrifuge System, K991430) and other table-top centrifuges. It states that "Performance Testing" was conducted to establish suitability for intended use, but does not detail the specific criteria, study design, or quantitative results of this testing. The information requested aligns more with the evaluation of AI/diagnostic software, which is not the nature of this particular device.

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The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated disposable processing set and whole blood access kit. The device is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The Blood Access Kit contains syringes, needles, anticoagulant, and a site preparation kit for collecting the blood to be processed with the Angel System. The Processing Set utilizes a variable volume separation chamber that separates autologous whole blood cells, platelet poor plasma, and platelet rich plasma. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single patient use only. The Processing Set consists of the pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag to hold the blood products (whole blood, red blood cells, and platelet poor plasma). A syringe is provided to collect the platelet rich plasma. The primary features of the Angel System hardware are the centrifuge well and lid, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch. The platelet sensor detects the presence of the separated blood components as they exit the variable volume separation chamber, and switches the position of a rotating valve in the Processing Set to channel the individual blood components into their respective collection containers.

The provided text describes the COBE® Angel Whole Blood Separation System and its 510(k) submission, focusing on establishing substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way envisioned by the prompt's request for performance metrics (e.g., sensitivity, specificity, accuracy).

The document is a regulatory submission for a medical device that processes blood, not an AI/algorithm-based diagnostic device where typical AI acceptance criteria would apply. Therefore, many of the requested items (like ground truth, expert opinions, MRMC studies, AI assistance) are not relevant to this type of device and are not present in the provided text.

Based on the available information:

1. A table of acceptance criteria and the reported device performance:
   The document states: "A comparison of device features and in-vitro test data demonstrate that the Angel Whole Blood Separation System is substantially equivalent to the currently marketed Medtronic Magellan Autologous Platelet Separator System."
   However, specific quantitative acceptance criteria (e.g., minimum purity of plasma, recovery rate of platelets) and the exact reported performance values are not detailed in the provided text. The assessment for this type of device focuses on demonstrating "substantial equivalence" to a predicate device, which implies that its performance is comparable and safe/effective for its intended use, but doesn't typically involve the same kind of detailed performance metrics as a diagnostic algorithm.

2. Sample size used for the test set and the data provenance:
   The document mentions "in-vitro test data" but does not specify the sample size, the type of test set (e.g., number of blood samples), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable and not provided as the device is a blood separation system, not an AI diagnostic system requiring expert-established ground truth for image or diagnostic interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable and 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:
   This information is not applicable and not provided as the device is a blood separation system, not an AI diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The concept of "ground truth" as typically used for AI diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For a blood separation system, "ground truth" would likely relate to objective measurements of the separated components (e.g., cell counts, protein concentrations) determined by laboratory techniques rather than expert consensus on diagnostic interpretation. The document does not detail these specific "ground truth" methods.

8. The sample size for the training set:
   The document does not mention a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
   This information is not applicable and not provided.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" through "comparison of device features and in-vitro test data" rather than providing a detailed breakdown of acceptance criteria and performance study results specific to AI/algorithm validation.

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The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.

SECQUIRE Cell Separator

The provided text is a 510(k) premarket notification letter from the FDA to Smith Associates regarding the SECQUIRE Cell Separator. This document is a regulatory approval letter and does not contain information about acceptance criteria or the study data proving the device meets those criteria.

The letter states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for its stated indications for use (preparation of low volume platelet rich plasma and platelet poor plasma at the point of care). However, it explicitly mentions a limitation: "The safety and effectiveness of this device for in vivo indications for use has not been established."

Therefore, based solely on the provided text, I cannot complete the requested table or answer the questions about acceptance criteria and study details. This information would typically be found in the 510(k) submission itself, including the detailed reports of performance studies, which are not part of this FDA clearance letter.

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The AutoloGel Process Centrifuge is designed to be used at the patient's point of care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).

The AutoloGel Process Centrifuge consists of a table-top, non self-decanting, rotor spin centrifuge and processing disposables designed to allow for rapid automatic separation of plasma and red blood cells from a small volume of whole blood. The centrifuge spins at a maximum speed of 7200 rpms producing a maximum force of approximately 4227 g.

This is a 510(k) summary for a medical device called the "AutoloGel Process Centrifuge." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing new acceptance criteria or conducting extensive performance studies like those typically seen for AI/ML devices. Therefore, many of the requested fields are not applicable or cannot be extracted from this type of submission.

Here's a breakdown of the information based on the provided text, with explanations where fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria, as one might see for performance metrics (e.g., sensitivity, specificity for an AI diagnostic), are not presented in this 510(k). The submission focuses on comparing the technological characteristics of the AutoloGel Process Centrifuge to predicate devices. The "performance" reported is inherent in its design specifications and its ability to achieve its intended use, which is to rapidly separate platelet-rich plasma (PRP).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) is for a general-purpose centrifuge, not an AI/ML device that would typically have a "test set" in the context of performance evaluation. The submission refers to performance data as "not provided" for this section (presumably because it's a mechanical device where performance is demonstrated through engineering specifications and comparison to predicates, not through clinical trials or retrospective data analysis of diagnostic outputs).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this is not an AI/ML diagnostic or predictive device, there is no "ground truth" established by experts in the context of image interpretation or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

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-assisted device for human readers.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for a centrifuge relates to its physical performance (e.g., achieving specified RPMs, RCFs, separation efficiency). This is demonstrated through engineering testing and design specifications, not through a "ground truth" methodology as used in AI/ML performance studies.

8. The Sample Size for the Training Set

Not applicable. This device is not developed using machine learning, 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.

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The GPS™ Platelet Separation kit is designed for use in the clinical laboratory or intraoperatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60 ml) of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

The GPSTM separation kit aids separation of the patient's own blood components by density through the use of the GPS™-Thermo International Equipment Company (IEC) centrifuge. The GPS™ separation kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient's blood that is drawn at the time of treatment.

Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 1/4" catheter, 60 ml piston syringe, 30 ml piston syringe, 1 ml piston syringe, petri dish, rubber tubing tourniquet, gauze pad, alcohol pad, adhesive tape, silicone tube, volume gauge, PETG tray with sealed Tyvek® lid, 50 ml bottle of anticoagulant citrate dextrose solution, U.S.P., Solution A (ACD-A).

The provided document is a 510(k) clearance letter for a medical device called the GPS™ Platelet Separation Kit with Anticoagulant ACD-A. This document describes the device, its intended use, and the basis for its clearance, which is substantial equivalence to a predicate device.

It is crucial to understand that a 510(k) clearance does not necessarily involve a study with acceptance criteria in the same way a de novo or PMA submission might, especially for diagnostic AI/ML devices. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" here are implicitly tied to the performance of the predicate device.

The request for information (table format, sample sizes, experts, adjudication, MRMC, standalone, ground truth type and training set details) is typically applicable to the validation of AI/ML-driven diagnostic devices. This 510(k) document is for a physical medical device for preparing blood components, not an AI/ML diagnostic system. Therefore, most of the requested information regarding AI/ML device validation is not present in this document.

However, I can extract the relevant information from the provided text as accurately as possible given the context of a 510(k) for a non-AI/ML device.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence claim for a physical kit (not an AI/ML diagnostic), the "acceptance criteria" are implied by demonstrating that the device performs comparably to its predicate device in its intended function: separating blood components to produce platelet-rich plasma (PRP).

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed under "Non-Clinical Testing" within the 510(k) submission for the predicate device (K021927). The current 510(k) (K030555) references these earlier tests to support its substantial equivalence claim, particularly for the physical separation kit components. The anticoagulant (ACD-A) specifically had relevant testing performed by its original manufacturer, Cytosol Laboratories, Inc.

Detailed Information Request (where applicable to this type of device):

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated in terms of a specific "test set" size. The document mentions "small sample (50-60 ml) of whole blood" as the input for the device, and "functional testing on bovine and human blood." The number of subjects or samples used in the predicate device's testing is not provided in this summary.
   • Data Provenance: Not specified (e.g., country of origin). The testing was "functional testing on bovine and human blood," indicating some human samples were likely involved, but specifics are absent in this summary. The anticoagulant testing was done by "Cytosol Laboratories, Inc."
   • Retrospective or Prospective: Not specified.

2. 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/Not provided. This device is a component separation kit. Its performance is assessed by quantitative measurements (e.g., platelet count, separation efficiency), not by expert interpretation of diagnostic images or data. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI/ML sense is not relevant here.

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

   • Not applicable/Not provided. As above, this is not an AI/ML diagnostic device requiring adjudication of interpretations.

4. 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-assisted diagnostic device.

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

   • Not applicable. This is not an algorithm-only device.

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

   • For this type of device, the "ground truth" would be quantitative laboratory measurements of blood component concentrations (e.g., platelet count, plasma volume, purity of separation) compared against expected or established values for effective PRP preparation. It is based on analytical and functional performance criteria, not expert interpretation of pathology or outcomes data in the usual sense.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. This is not an AI/ML device that requires a training set.

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