(132 days)
The Dermapose Refresh is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
The Dermapose Refresh is a sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 um filter for screening the tissue particle size to allow for easier injection through small, 18-21G injection cannulas. For optimum performance, Dermapose™ Refresh should be used in conjunction with the Dermapose™ Refresh Stand, which is a reusable, autoclavable component designed to hold the syringe securely during use.
The Dermapose™ Refresh is comprised of the following:
- 50 mL polycarbonate harvesting and processing syringe unit preassembled with a 30 mL polycarbonate output syringe
- Two 30 mL syringes
- Three luer caps
- Luer-to-luer adapter
The Dermapose™ Refresh is also intended to be used with Lactated Ringer's solution, injection syringes (1 or 3 mL recommended), injection cannulas (18-21G recommended), and luer-lock harvest cannula (14G recommended) which are provided by the user. Dermapose™ Refresh should be used in conjunction with the 510(k)-exempt Dermapose TM Refresh Stand.
The provided text describes a 510(k) premarket notification for the Dermapose Refresh device. It indicates that performance and biocompatibility testing were conducted, but it does not provide detailed acceptance criteria, reported performance values, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) for the performance testing.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance:
The document states: "The Dermapose™ Refresh was tested in accordance with established protocols and met the acceptance criteria for all tests performed." However, it does not explicitly list the acceptance criteria or the specific reported device performance values for the tests mentioned.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states that the device "met the acceptance criteria." | Not provided in the document. The document states that the device "met the acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not provided. The document lists types of performance tests (Nucleated Cell Viability, Tissue Composition, System Leak, Mechanical Test), but does not specify the number of samples or runs for any of these tests.
- Data Provenance: Not provided. The document does not specify the origin of the data (e.g., country) or whether the studies were retrospective or prospective.
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 as the described tests (cell viability, tissue composition, leak, mechanical) are objective laboratory or engineering tests, not studies requiring expert interpretation of images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there were no subjective assessments requiring adjudication described in the provided text.
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 device, Dermapose Refresh, is a medical device for processing adipose tissue, not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.
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 physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the described performance tests:
- Nucleated Cell Viability: The ground truth would be established by the measurements from the Luna-Stem Automated Fluorescence Cell Counter.
- Tissue Composition: The ground truth would be established by analytical methods for assessing adipose tissue layers.
- System Leak: The ground truth would be established by quantitative measurements of vacuum retention.
- Mechanical Test: The ground truth would be established by engineering specifications and measurements of mechanical connections.
These are objective measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.
8. The sample size for the training set:
This information is not applicable. The Dermapose Refresh is a physical medical device, 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 due to the nature of the device as explained in point 8.
§ 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.