Search Results

Aesthetic body contouring

The body-jet®, a suction lipoplasty system, is a device intended for aesthetic body contouring. The device consists of a powered vacuum pump (containing an overflow/bacterial filter in the tube between the vacuum pump and suction bag), a collection bag with integrated overflow/bacterial filter, cannulae, and a connecting tube. The suction/collection bags including bacterial filters, the tubing, and the cannulae are to be changed between patients. The powered vacuum pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 26.5 inches of mercury, vacuum control valve to regulate the vacuum with accompanying vacuum gauge, a double piston, and a safety trap. The powered vacuum pump generates a negative pressure for the removal of fat or adipose tissue from distinct body-fat deposits for aesthetic body-contouring.

The body-jet® includes a sterile, single-use tubing set with a small infiltration pump (the WAL Applicator), which transports the saline for the infiltration of the tissue area to be treated, and infiltration and irrigation cannulae. The single-use tubing set (WAL Applicator) and the reusable cannulae have been designed as proprietary products.

The provided document is a 510(k) summary for the "body-jet®" suction lipoplasty system. It focuses on demonstrating substantial equivalence to predicate devices for aesthetic body contouring. The document does not describe acceptance criteria and a study proving the device meets those criteria in the typical format of a diagnostic or AI/machine learning device. Instead, it demonstrates safety and effectiveness through comparisons to existing devices and in-vitro studies.

However, I can extract the relevant information and present it in a structured way that aligns with your request, interpreting "acceptance criteria" as the demonstration of "substantial equivalence" and "performance" as the findings supporting this equivalence for the described device, though it's not a direct match to a standard AI/diagnostic performance study.

Here's an attempt to answer your questions based on the provided document, acknowledging that some fields may not be directly applicable or fully detailed for this type of device submission:

1. Table of acceptance criteria and the reported device performance

For a device like the body-jet®, the "acceptance criteria" are generally based on demonstrating substantial equivalence in terms of intended use, technological characteristics, safety, and effectiveness compared to legally marketed predicate devices. The performance data presented are primarily to support these claims.

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:
  • In-vitro studies (Histopathological/Immunohistological Performance Data): "Two in-vitro laboratory investigations have been carried out. on fat tissue samples from human corpses (Investigation 1), and from "dead" abdominal fat excisates (Investigation 2)." The specific number of samples or excisates is not provided.
  • Clinical Performance Data: This refers to "published clinical performance data," indicating a review of existing literature. The specific number of patients or studies reviewed is not mentioned.
• Data Provenance: Not explicitly stated for either the in-vitro studies or the published clinical data. "Human corpses" and "abdominal fat excisates" are mentioned for in-vitro. For clinical data, it's a review of "published" data, suggesting existing studies that could be from various countries and collected retrospectively or prospectively.

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)

• The document does not specify the number of experts or their qualifications for evaluating the histopathological slides or for the clinical data review. The analysis summarized in "Section 18" (histopathology) and "Section 20" (clinical) would have been performed by qualified personnel (e.g., pathologists for histopathology, clinicians for clinical data review), but details are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided in the document. It's unlikely to be applicable in the same way it would be for ground truth establishment in a diagnostic imaging study.

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

• No MRMC comparative effectiveness study was done. This type of study (human readers with/without AI assistance) is typically relevant for diagnostic AI devices, not for a lipoplasty system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable to the body-jet® device, which is a physical medical device (suction lipoplasty system), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the in-vitro studies: Histopathological analysis and immunohistological performance data on tissue structures (adipose, connective, muscle, blood vessels, nerves). This implies assessment by pathologists.
• For the clinical performance: A review of "published clinical performance data" to assess safety and effectiveness. This would involve synthesis of reported outcomes data from existing studies.

8. The sample size for the training set

• This device does not involve a "training set" in the context of machine learning or algorithms. The device's design and performance are based on engineering principles and pre-clinical/clinical validation, not on algorithm training.

9. How the ground truth for the training set was established

• This question is not applicable as there is no training set for this device.

Ask a specific question about this device