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510(k) Data Aggregation
(171 days)
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.
| Feature / Criteria (Implied) | Harvest AdiPrep™ Adipose Transfer System (This submission) | Predicate Viafill System (K081848) | Predicate Vortech™ Adipose Transfer System (K100114) |
|---|---|---|---|
| Autologous Adipose Product | |||
| Nucleated Cell Count (x10³/ml of Product) | Mean 1.823 | Mean 1.848 | Actual results not available; claimed substantially equivalent to Viafill. |
| Nucleated Cell Viability (%) | Mean 83.5 | Mean 82.4 | Actual results not available; claimed substantially equivalent to Viafill. |
| Processing Capabilities / Volume | Volume = 5 mL to 25 mL | Volume = 5 mL to 20 mL | Volume = 180 mL |
| Processing Capabilities / g-force | Centrifuge to spin for approx. 4 minutes at 1250 g-force. | Centrifuge to spin for 2 minutes at 50 g-force. | 4 1/2 minute centrifugation process, g-force unknown. |
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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(105 days)
The Cytori PureGraft 250/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.
The Cytori PureGraft 250/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. Cytori PureGraft 250/PURE consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly.
The Cytori PureGraft 250/PURE System is a medical device used for processing autologous fat tissue for reinjection. The provided text outlines its similarity to predicate devices rather than detailing specific performance testing with acceptance criteria.
Based on the provided text, a table of acceptance criteria and reported device performance cannot be fully constructed because the document focuses on demonstrating substantial equivalence to predicate devices rather than presenting explicit performance metrics and thresholds for the Cytori PureGraft 250/PURE System itself.
However, we can infer some "acceptance criteria" through the lens of substantial equivalence and outline what information regarding device performance is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices) | Reported Device Performance (as described in the document) |
|---|---|
| Indications for Use: Ability to harvest, filter, and transfer autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring. | Performance: "The Cytori PureGraft 250/PURE System and the predicate devices are substantially equivalent with respect to their indications for use, as they are all indicated for the same surgical procedures of harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient." |
| Design and Materials: Single-use, polymer-constructed, manually operated system with a filtration mechanism. | Performance: "The design and materials of the Cytori PureGraft 250/PURE System and the predicate devices are substantially equivalent, as they are all single-use, polymer constructed, manually operated systems that receive adipose tissue, filter the adipose tissue, and temporarily hold the adipose tissue until it is removed or placed into a syringe that delivers / re-injects the adipose tissue back into the same patient during the same surgical procedure." |
| Filtration Mechanism: Polymeric housing chamber with a filter unit, allowing fluids and small debris to pass through to a waste container while retaining adipose tissue. | Performance: "The Cytori PureGraft 250/PURE System is substantially equivalent to the predicate devices as they all consist of a polymeric housing chamber with a filter unit within the chamber... contain a filtering mechanism of various pore sizes that restricts the movement of adipose tissue and only allows fluids and small debris to pass through the filter and become deposited into a waste container." (Specifically mentions 1,000 micron and 74 micron filters for the PureGraft 250mL Bag). |
| Tissue Volume Capacity: Comparable to predicate devices. | Performance: "The Cytori PureGraft 250/PURE System is also substantially equivalent to the predicate devices as they all have substantially equivalent tissue volume capacities." |
| Sterility: Must be sterile. | Performance: "The Cytori PureGraft 250/PURE System is sterilized with gamma irradiation." (Implied performance is that it is sterile.) |
| Mechanical Integrity/Durability: Must function as intended without failure. | Performance: "Mechanical testing of the Cytori PureGraft 250/PURE System demonstrates that the device is substantially equivalent to the predicate devices." (Implied performance is robust similar to predicates.) |
| Material Composition: Medical grade and DEHP-free. | Performance: "The Cytori PureGraft 250/PURE System is fabricated from medical grade, DEHP free materials." (Implied performance is that it meets these standards.) |
2. Sample size used for the test set and the data provenance:
- The document does not provide details on a specific "test set" with a sample size for the Cytori PureGraft 250/PURE System's performance in harvesting, filtering, and transferring fat tissue in a clinical or simulated environment.
- The primary evidence presented is a comparison to predicate devices, focusing on substantial equivalence in design, materials, and indications for use.
- The "Mechanical testing" mentioned is general and does not specify sample sizes 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 provided in the document. The submission is a 510(k) for substantial equivalence, which primarily relies on comparison to existing legally marketed devices rather than de novo clinical performance studies that require ground truth establishment by experts in the context of diagnostic or efficacy claims.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as there is no described test set that would necessitate an adjudication method for establishing ground truth.
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:
- An MRMC study is not applicable to this device. The Cytori PureGraft 250/PURE System is a medical device for processing fat tissue, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This concept is not applicable to this device. The Cytori PureGraft 250/PURE System is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of "ground truth" as typically applied to performance studies of diagnostic or image analysis systems is not directly relevant or explicitly stated for this device in the provided text.
- The "ground truth" for substantial equivalence here relies on the established safety and effectiveness of the predicate devices for their indicated uses, and ensuring the new device shares fundamental technological characteristics and indications.
8. The sample size for the training set:
- This information is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable as the device is not an AI/machine learning model.
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