Search Results

The SmartGraft™ 200 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraft™ 200 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.

The SmartGraft™ 200 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, and
• · Arthroscopic Surgery

The SmartGraft™ 200 System is a disposable process pack to be used with the InGeneron Tissue Processing Unit (centrifuge). The process pack is a collection of sterile single-use off-the-shelf and proprietary components used during the process of harvesting, centrifugation, and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.

The provided text describes a 510(k) premarket notification for the SmartGraft™ 200 System. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than proving device performance against specific acceptance criteria for AI/algorithm-based diagnostic tasks. Therefore, many of the requested elements for an AI study are not applicable or cannot be extracted from this document.

However, I can extract information related to the device description and the non-clinical studies performed to support substantial equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) or not provided:

Device Description:

The SmartGraft™ 200 System is a disposable process pack used with the InGeneron Tissue Processing Unit (centrifuge). It is a collection of sterile, single-use, off-the-shelf and proprietary components.

Intended Use:

The system is intended for use in medical procedures involving the harvesting, centrifugation, and transferring of autologous adipose tissue. It is used for concentrating adipose tissue for aesthetic body contouring and for tissue harvested with a legally marketed lipoplasty system.

Surgical Specialties for Use:

• Neurosurgery
• Gastrointestinal Surgery
• Urological Surgery
• Plastic and Reconstructive Surgery
• General Surgery
• Orthopedic Surgery
• Gynecological Surgery
• Thoracic Surgery
• Laparoscopic Surgery
• Arthroscopic Surgery

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a physical device (lipoplasty system), not an AI algorithm, the concept of "acceptance criteria" for diagnostic performance metrics (like sensitivity, specificity, accuracy) is not directly applicable in the same way as for an AI diagnostic device. The "performance" here relates to functional performance, safety, and substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a numerical sample size for the "two non-clinical studies" mentioned. It only refers to "lipoaspirate."
• Data Provenance: N/A for country of origin as these were bench tests. The studies were non-clinical/bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: N/A. Ground truth in this context would likely be defined by calibrated instruments or standard laboratory protocols for measuring cell viability, not expert interpretation.
• Qualifications of Experts: N/A.

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

• N/A. Adjudication methods are typically relevant for human interpretation of data in diagnostic tasks, which is not the primary focus of this device's evaluation.

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:

• N/A. This device is not an AI diagnostic tool and does not involve human readers interpreting images with or without AI assistance.

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

• N/A. This is a physical medical device, not a standalone AI algorithm.

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

• For "nucleated cell viability," the ground truth would likely be established through standard laboratory assays and microscopy/cell counting techniques.
• For "usability" and "operation," the ground truth would be successful completion of specified tasks and adherence to performance specifications.

8. The sample size for the training set:

• N/A. This device is not an AI algorithm requiring a training set.

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

• N/A. This device is not an AI algorithm requiring a training set.

Ask a specific question about this device

The SmartGraft™ 30 system is intended to be used in medical procedures involving the harvesting, centrifugation and transferring of autologous adipose tissue. The SmartGraff™ 30 system is used for concentrating adipose tissue for aesthetic body contouring, and for tissue that has been harvested with a legally marketed lipoplasty system.

The SmartGraft™ 30 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 SmartGraft™ 30 System is a disposable process pack to be used with the InGeneron Tissue Processing Unit (centrifuge). The process pack is a collection of sterile single-use off-the-shelf and proprietary components used during the process of harvesting, centrifugation and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.

Thislooks like a 510(k) summary for a medical device called the SmartGraft™ 30 System. The FDA has determined the device to be substantially equivalent to previously marketed devices. The document highlights the device's intended use in processing autologous adipose tissue and its technological characteristics.

The summary describes bench testing conducted to support the claim of substantial equivalence. However, it does not contain the detailed acceptance criteria or the specific study results in the format requested, particularly regarding statistical performance, sample sizes for training/test sets, expert ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for the tables and specific details about acceptance criteria, reported performance, sample sizes, and ground truth establishment from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence rather than detailed performance metrics.

What the document does provide concerning testing:

• Bench Testing: Two non-clinical studies were performed on the SmartGraft™ 30 system.
  • Study 1: Usability and Operation: Evaluated the system's usability according to Instructions for Use and its ability to produce concentrated adipose tissue from lipoaspirate.
  • Study 2: Nucleated Cell Viability: Investigated the viability of nucleated cells in concentrated adipose tissue produced by the SmartGraft™ 30 system compared to unprocessed adipose tissue.
• Result of Viability Study: The results indicated that the SmartGraft™ 30 system "does not adversely impact viability of the adipose tissue." It concludes that the "Impact of the SmartGraft™ 30 system on cell viability is then substantially equivalent to that of predicate devices."
• Ground Truth for Bench Testing: For the usability and operation study, the ground truth was likely based on successful operation according to the Instructions for Use and the production of concentrated adipose tissue. For the cell viability study, the ground truth was "unprocessed adipose tissue" for comparison.
• No information is provided regarding:
  • Specific quantitative acceptance criteria (e.g., "X% accuracy," "Y cells/mL viable").
  • Specific reported device performance in numerical terms.
  • Sample sizes used for these tests.
  • Data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance (as this is a physical device, not an AI algorithm).
  • Training set sample size or how its ground truth was established.

Ask a specific question about this device