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The AdiPrep™ Adipose Transfer System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The AdiPrep system is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The AdiPrep™ Adipose Transfer 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 Reconstructive Surgery
• General surgery

• Orthopedic Surgery .
• . Gynecological Surgery
• Thoracic Surgery .
• Laparoscopic Surgery .
• Arthroscopic Surgery ●

The Harvest AdiPrep Adipose Transfer System consists of a disposable process pack to be utilized with the SmartPReP2 centrifuge. The process pack is a sterile (EtO) single use disposable pack used for the aspiration, harvesting, and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.

Here's a breakdown of the acceptance criteria and study information for the Harvest AdiPrep™ Adipose Transfer System based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices rather than pre-defined acceptance criteria with specific thresholds for the new device. The performance is presented as a comparison to predicate devices.

Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion here is demonstrating that the Harvest AdiPrep system performs comparably to the legally marketed predicate devices, specifically in terms of nucleated cell count and viability of the autologous adipose product. The stated results show very similar mean values for both nucleated cell count and viability between the AdiPrep system and the Viafill predicate, supporting the claim of substantial equivalence.

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

• Sample Size: Not explicitly stated as a number of patients or samples. The document mentions "Clinical testing was performed to determine substantial equivalence to the predicate device."
• Data Provenance: Not specified (e.g., country of origin). The study appears to be retrospective or prospective, as it involved clinical testing to generate data for comparison. It is likely prospective as it's directly testing the new device.

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

There is no mention of "experts" or "ground truth" in the context of human expert review. The study focuses on direct biological measures (cell count and viability) of the processed adipose tissue, which are objective laboratory measurements, not subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. There was no expert review or adjudication process as the study involved objective laboratory measurements of device output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is a medical processing system for adipose tissue, not an imaging or diagnostic device that requires human interpretation. Therefore, there is no mention of human readers or AI assistance.

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

The device itself is a standalone system for processing adipose tissue. The "clinical testing" performed evaluated the output of this standalone system (nucleated cell count and viability). There is no "algorithm" or AI component involved in this device, so the terminology of "standalone algorithm performance" does not directly apply. However, the performance reported is the standalone output of the device itself.

7. The Type of Ground Truth Used

The "ground truth" here is established through objective laboratory measurements of the processed autologous adipose tissue, specifically:

• Nucleated Cell Count
• Nucleated Cell Viability

8. The Sample Size for the Training Set

There is no mention of a "training set" in this context. The device is a mechanical/biological processing system, not an AI or machine learning algorithm that requires a training set. The clinical testing mentioned is for verification and validation, not model training.

9. How the Ground Truth for the Training Set Was Established

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

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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 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 Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

The Harvest Graft Delivery System consists of a Graft Syringe/Infusion Chamber with pre-seated polymer plug and removable plunger and syringe cap; a dual liquid applicator; female/female luer connector and push rod. A commercially available bone marrow aspirate needle is supplied separately for use with the system.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria.

The document is a 510(k) Summary for the Harvest Graft Delivery System, which describes the device, its intended use, and states its substantial equivalence to predicate devices based on technological characteristics (similar design and configuration). It does not contain details of any specific performance studies with acceptance criteria, sample sizes, ground truth, or expert involvement.

The 510(k) process for this device (a Piston Syringe) relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily based on design, intended use, and technological characteristics, rather than requiring extensive clinical performance studies with specific statistical acceptance criteria as might be seen for novel or higher-risk devices.

Therefore, I cannot answer the requested points (1-9) as the information is not present in the provided text.

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The SmartJet Grafting Liquid Applicator is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

The Harvest SmartJet Grafting Liquid Applicator is provided sterile in a sealed pouch and is intended for a single use. The device consists of the following components:
Two commercially available disposable medical piston syringes.
Applicator Tip (spray or dual cannula)
Handle Frame, and
Plunger Clip

This 510(k) summary for the Harvest SmartJet Grafting Liquid Applicator indicates that the device has been found substantially equivalent to a predicate device (Harvest SmartJet Bone Grafting Liquid Applicator, cleared under 510(k)011032) based on technological characteristics and design. It states that the proposed device has the same technological characteristics and is identical in design and configuration to the predicate device, and the materials of manufacture have been demonstrated to be suitable for the intended use.

This implies that the acceptance criteria for this 510(k) submission were primarily based on demonstrating substantial equivalence to the predicate device, rather than explicit performance metrics from an independent study in the current filing. The FDA's letter confirms substantial equivalence without requiring a new clinical study.

1. Table of Acceptance Criteria and Reported Device Performance:

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

No explicit test set or clinical study data is provided in this 510(k) summary for the Harvest SmartJet Grafting Liquid Applicator to demonstrate performance against specific criteria. The submission relies on the established substantial equivalence to the predicate device.

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

Not applicable, as no new test set requiring expert ground truth establishment for performance evaluation against specific metrics is described in this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable, as no new test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned for this 510(k) submission.

6. Standalone (Algorithm Only) Performance Study:

Not applicable, as this device is a manual surgical instrument, not an algorithm.

7. Type of Ground Truth Used:

Not applicable, as no new study requiring ground truth is described. The "truth" in this context is the FDA's acceptance of substantial equivalence to a previously cleared device.

8. Sample Size for the Training Set:

Not applicable, as this device is a manual surgical instrument and does not involve a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this device is a manual surgical instrument and does not involve a "training set" or ground truth establishment in this manner.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) review process itself, which concluded that the Harvest SmartJet Grafting Liquid Applicator is substantially equivalent to its predicate device, the Harvest SmartJet Bone Grafting Liquid Applicator (K011032). This determination was based on:

• Comparison of Technological Characteristics/Performance Data: The submission explicitly states, "The proposed device has the same technological characteristics and is identical in design and configuration compared with the predicate device. The materials of manufacture have been demonstrated to be suitable for the intended use specified."
• Predicate Device Equivalence: The predicate device had already undergone FDA clearance, meaning its safety and effectiveness for its intended use were established. By demonstrating that the new device is essentially the same in terms of design, materials, and intended purpose (with an expanded indications for use that was also deemed acceptable), the need for new, extensive performance studies was circumvented.

The FDA's decision to clear the device "based upon the information you supplied, we have determined the device is substantially equivalent" confirms that this comparison was sufficient to meet their regulatory requirements for acceptance. No new independent performance studies or clinical trials specific to this 510(k) for this device are described in the provided text.

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