(142 days)
The GID 700 is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
The GID 700 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
The GID Group's GID 700 device is a sterile, single use 700 ml canister and accessories used to receive and filter tissue from lipoplasty procedures. When the tissue is deposited into the canister, it is filtered through a mesh filter to capture the tissue. The vacuum source is user or institution supplied. Various ports on the canister provide access to the vacuum source, receives the harvested tissue, vent the canister during the wash process, and transfer the filtered tissue.
The GID 700 Tissue Canister is a medical device used for aspirating, harvesting, filtering, and transferring autologous adipose tissue. The provided documents detail its performance and acceptance criteria for FDA 510(k) clearance, establishing substantial equivalence to a predicate device (Shippert Tissu-Trans Filtron 1000 canister).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (GID 700) |
|---|---|
| Canister vacuum Implosion Test | Passes |
| Tubing connection, tensile strength | Passes |
| Mechanical plugging testing | Passes |
| Biocompatibility (ISO 10993) | Meets ISO 10993 requirements |
| Pyrogen Test | Non-pyrogenic |
2. Sample Size Used for the Test Set and Data Provenance
The documents describe various physical and biological tests conducted on the GID 700 device itself, rather than a clinical study involving a "test set" of patient data in the typical sense for AI/ML devices. Therefore, a sample size for a "test set" or data provenance (country of origin, retrospective/prospective) is not applicable in this context. The tests performed are laboratory-based evaluations of the device's physical and material properties.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of device and study described. The GID 700 is a physical medical device, not an AI/ML algorithm that requires expert consensus for ground truth establishment. The performance data is derived from direct measurements and laboratory tests.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" of patient cases requiring adjudication by experts. The performance is based on direct physical and biological testing of the device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for AI/ML diagnostic or prognostic tools to assess how human readers' performance (e.g., accuracy, efficiency) is improved with AI assistance. The GID 700 is a physical tissue collection and processing device, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone algorithm performance study was not done. The GID 700 is a physical device, and therefore this type of study, relevant to AI/ML algorithms, is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the GID 700's performance is established through direct physical and biological testing standards and requirements. For instance:
- Physical Tests: "Passes" for implosion, tensile strength, and mechanical plugging indicate meeting pre-defined engineering specifications and safety thresholds.
- Biocompatibility: Conformance to ISO 10993 standards serves as the ground truth for the device's biological safety when in contact with human tissue.
- Pyrogen Test: A "non-pyrogenic" result confirms the absence of fever-inducing substances, which is a direct biological safety standard.
8. The Sample Size for the Training Set
This information is not applicable. The GID 700 is a physical medical device, not an AI/ML algorithm that undergoes a "training" process with a dataset. Its design and manufacturing are based on established engineering principles and material science.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" for a physical device. Its design is based on engineering specifications and regulatory requirements for predicate devices.
§ 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.