(259 days)
The Automatic Tissue Processing Unit is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The Automatic Tissue Processing Unit is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Automatic Tissue Processing Unit 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 Arthoscopic 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 etc. In addition, the harvested fat tissues are not homogenous and contain uneven fibrotic tissues. So, for the purpose of in autologous fat transfer surgical technique. ACPU kit is designed and developed for harvest of the fine homologous adipose tissue in a sterile and closed way. ACPU needs to be centrifuged by using exclusive centrifuge (ACS Combo-A-Centrifuge/Product code: JQC) and the kits are single-use only.
Here's an analysis of the provided FDA 510(k) summary regarding the Automatic Tissue Processing Unit, structuring the information according to your requested points:
Device: Automatic Tissue Processing Unit (ACPU-100/ACPU-200)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful results of the specified tests, indicating that the device meets predetermined standards for each parameter. The "Requirements" column serves as the acceptance criteria.
| Test Item | Acceptance Criteria (Requirements) | Reported Device Performance (Results) |
|---|---|---|
| Appearance | No defects, flaws, breakage, or contamination of foreign objects. | Pass |
| Measurement | Within ±5% of stated dimensions. | Pass |
| Leakage | No leakage. | Pass |
| Residuals of cleaning liquid | Less than 20 ml. | Pass |
| Packaging | Adhesive strength not less than 3N (ASTM F-88). | Pass |
| Nucleated Cell Count | More than 3.86x10^5 per ml of adipose tissue. | "3.86 over" - Implies greater than or equal to, thus meeting the criteria. |
| Nucleated Cell Viability | More than 71.4%. | "71.4% over" - Implies greater than or equal to, thus meeting the criteria. |
| Extraction test: | ||
| Appearance (sample prep extract) | No foreign material. | Pass |
| pH (Difference) | ≤ 1.5 | Pass |
| KMnO4 Reducing agents (Difference in titres) | ≤ 2.0 ml | Pass |
| Evaporating residue (Difference in extractables) | ≤ 1.0 mg | Pass |
| Heavy metal (as Pb) | Not darker than standard solution. | Pass |
| UV-vis Spectrum (Difference in absorbance 250nm-350nm) | ≤ 0.1 | Pass |
| Biocompatibility Tests: | ||
| Cytotoxicity (ISO 10993-5) | Pass (implicitly defined by standard) | Pass |
| Skin Sensitization (ISO 10993-10) | Pass (implicitly defined by standard) | Pass |
| Intracutaneous Reactivity Test (ISO 10993-10) | Pass (implicitly defined by standard) | Pass |
| Acute Systemic Toxicity Test (ISO 10993-11) | Pass (implicitly defined by standard) | Pass |
| Pyrogen Test (ISO 10993-11, Annex F) | Pass (implicitly defined by standard) | Pass |
| Hemolysis Test (ISO 10993-4) | Pass (implicitly defined by standard) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "bench tests." The tests listed are primarily physical, chemical, and biological characterization tests performed on the device itself or its materials, rather than a clinical human subject test set. The data provenance is not specified, but these are laboratory tests rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Since the tests performed are bench tests (biocompatibility, mechanical, sterility, extraction, cell counts/viability), the concept of "ground truth" established by human experts in a diagnostic or clinical context is not applicable. The ground truth for these tests is based on objective laboratory measurements and established scientific standards (e.g., ISO guidelines, ASTM standards, chemical analysis techniques).
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where human interpretation of medical images or outcomes needs consensus. For the bench tests described, adjudication is not applicable. The "results" are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document describes bench testing to demonstrate functionality and substantial equivalence to a predicate device, not a human reader study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is an Automatic Tissue Processing Unit, a mechanical/biological processing system, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance data in this submission consists of:
- Objective physical measurements: Dimensions, leakage, adhesive strength.
- Chemical analysis results: Residuals of cleaning liquid, pH, KMnO4 reducing agents, evaporating residue, heavy metals, UV-vis spectrum.
- Biological assay results: Nucleated cell count and viability.
- Standardized biological test outcomes: Biocompatibility tests (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis) performed according to ISO standards, where "Pass" is the objective outcome based on the standard's criteria.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The data presented is for validation and verification of the physical device's performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.