(125 days)
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.
| Acceptance Criteria (Implicit from 510(k) Standards) | Reported Device Performance (Summary from Bench Testing) |
|---|---|
| Usability according to Instructions for Use | System performs to specification and can be operated successfully with provided Instructions for Use. |
| Operation to produce concentrated adipose tissue | System successfully produces concentrated adipose tissue from lipoaspirate. |
| Impact on nucleated cell viability | Does not adversely impact the viability of adipose tissue (compared to unprocessed tissue), indicating substantial equivalence to predicate devices' impact on cell viability. |
| Biocompatibility | Tested for biocompatibility to ISO 10993. |
| Sterilization effectiveness | Sterilized using standard methods (EO gas), similar to predicate devices. |
| Materials of construction | Uses equivalent polymeric materials of construction; made of medical-grade polymer materials. |
| Operating principle (low g-force centrifugation) | Utilizes low g-force centrifugation for short periods of time, consistent with predicate devices. |
| Volume of adipose tissue processed | Volume processed is essentially identical to one predicate device and larger than the other. |
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.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.