(197 days)
The Smart Kit is disposable and is indicated for autologous fat transfer is also technically called as autologous fat grafting or reinjection of concentrated adipose-tissue into the recipient body areas. The Smart kit can be used for concentration and transfer of homogenous adipose tissues with legally marketed lipoplasty system when the concentrated and homogenous fat tissue is re-injected into the recipient body areas of the same patient autologously. This device is intended for autologous fat transfer. The Smart Kit is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. Neurosurgery / Gastrointestinal Surgery / General surgery / Orthopedic Surgery / Gynecological Surgery / Thoracic Surgery / Laparoscopic Surgery / Arthroscopic Surgery / Plastic and reconstructive surgery
The fat harvested by liposuction, called as lipoaspirates, contains fat tissues, bloody impurities and tumescent solution. The harvested lipoaspirates are not appropriate for autologous fat transfer without removal of the bloody impurities and tumescent solution containing anesthetic agent, anti-coagulant agent, antibiotics and etc. In addition, the harvested fat tissues are not homogeneous and contain bigger fibrotic tissues. Smart kit is designed and developed for harvest of a variety of sizes of homogeneous adipose tissues in a closed sterile way for autologous fat transfer surgical technique. Using a separate cannula, Manual handheld suction unit, and plunger, aspirate the adipose tissue or fill the syringe with adipose tissue and centrifuge with the cap in front of the syringe. Centrifuged adipose tissue is divided into blood and fluid layer, adipose tissue layer, and free oil layer. Those are located at the bottom of the piston. After centrifugation, the plunger is pushed unlocked to the piston and free oil is drained to the outside of the syringe as the free oil moves to the top of the piston through the hole at the front of the piston. Open the cap in front of the syringe, lock the plunger completely and push it, the blood and fluid layers at the bottom of the adipose tissue will be drained and only the adipose tissue will remain inside the syringe. Depending on the syringe capacity, there are three types of piston: 10ml, 20ml, 60ml. The built-in filter adapter consists of a filter for separating the fiber and adipose tissue to facilitate movement through needles of lumpy adipose tissues and a body for receiving it. Connect the syringe containing the adipose tissue and the empty syringe to the connection parts at both ends of the built-in filter adapter and push the plunger of the syringe containing the adipose tissue to allow the adipose tissue to pass through the filter. Fiber and adipose tissues larger than the pore size is filtered, and adipose tissue smaller than the pore size of the filter is passed through to separate adipose tissue.
The provided text describes a medical device called "Smart Kit" and its performance testing for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device. However, the document does not contain details of a study proving the device meets acceptance criteria related to a specific AI algorithm or its performance in a clinical setting.
The "Performance Testing" section focuses on physical and chemical properties of the device itself (e.g., appearance, water tightness, material compatibility, sterilization). The "Cell Viability Test" is the most relevant performance metric that could be interpreted as a clinical outcome, but it is a general statement about maintaining cell viability for autologous fat transfer.
Therefore, most of the requested information about AI model performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone AI performance cannot be extracted from this document, as it describes a physical medical device, not an AI algorithm.
Below is a table of acceptance criteria and reported device performance from the document. The remaining requested information is largely not applicable or not provided in the context of this device's clearance.
Acceptance Criteria and Reported Device Performance (Smart Kit)
| Test Item | Test Requirement | Reported Device Performance |
|---|---|---|
| Appearance | There should be no visible scratches, damage, or foreign material | Met acceptance criteria for all tests performed. |
| Measurement | When measuring with Vernier calipers, according to the dimension of "shape and structure" part, the stated should be within ± 5% | Met acceptance criteria for all tests performed. |
| Water Tightness | When tested according to the test method, there should be no leakage | Met acceptance criteria for all tests performed. |
| Centrifugation Compatibility Test (Leakage) | When tested according to the test method, it should be aspirated to the maximum capacity without leakage | Met acceptance criteria for all tests performed. |
| Cell Viability Test | The finally filtered adipose tissues for autologous fat transfer should maintain at least over 85 % of the cell viability. | Met acceptance criteria for all tests performed. |
| Pore Size | When measuring with Vernier calipers, according to the dimension of 'shape and structure' part, the stated should be within ± 15 %. | Met acceptance criteria for all tests performed. |
| pH | Difference of pH $\leq$ 1.5 | Met acceptance criteria for all tests performed. |
| Potassium permanganate reducing substances | Difference of the consumption $\leq$ 2.0 mL | Met acceptance criteria for all tests performed. |
| Evaporating residue | Difference of residues $\leq$ 1.0mg | Met acceptance criteria for all tests performed. |
| Heavy Metals | The test solution should not be darker than blank solution. | Met acceptance criteria for all tests performed. |
| Ultraviolet-visible | Difference of the maximum absorbance at (250~350) nm $\leq$ 0.1 | Met acceptance criteria for all tests performed. |
Study Details (Information Not Provided or Not Applicable to AI Performance)
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document describes performance testing for a physical device, not an AI algorithm evaluated on a clinical test set.
- 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):
- Not applicable/Not provided. This information is relevant for AI validation studies involving expert annotations, which is not the subject of this document. The 'Cell Viability Test' implies a laboratory-based assessment, not expert interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This pertains to expert review in AI studies.
- 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:
- No. This is not a study about AI assistance or human reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The "Smart Kit" is a physical device for autologous fat transfer, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests listed, the "ground truth" would be established by laboratory measurements, physicochemical standards, and biological assays (e.g., cell viability assays). It is not expert consensus, pathology, or outcomes data in the typical sense of AI/clinical studies.
- The sample size for the training set:
- Not applicable/Not provided. The document describes a physical medical device. There is no mention of an AI algorithm requiring a training set.
- How the ground truth for the training set was established:
- Not applicable/Not provided. No training set is mentioned as there is no AI algorithm being validated.
§ 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.