(283 days)
The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:
- Aspiration of adipose (fatty) tissue
- Harvesting adipose (fatty) tissue
- Filtering adipose (fatty) tissue
- Extraction of autologous adipose (fatty) tissue
Device Functions:
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- Single Use closed loop system collection device (same)
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- Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump.
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- Connection system to connect tubing to interfaces
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- Funnel to enable fat to separate from fluids
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- Channel for fluid evacuation.
- Toomey Syringe to extract fat from device. 6.
Device Design:
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- Owner holds patent to predicate device and has improved performance and safety through this design.
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- Non-Sterile, Single Use
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- Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting.
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- Tissue enters canister through collection port on canister lid.
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- Funnel perforation large enough for only adipose (fatty) tissue to be collected
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- Waste material is removed from canister by closing valve on center of lid.
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- Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction.
Physical Properties and Materials Used:
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- Canister, Funnel and Outer Lid made from Polycarbonate
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- Evacuation spout and pinch clamps made from Polypropylene
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- Tubing made from silicone
Intended use of Device:
For use in aspirating subcutaneous fatty tissue including autologous fat collection.
The provided document describes a medical device, "The Red Head and Jordy Connection System," and its substantial equivalence to a predicate device, "Lipisystems Aquavage." This is a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence rather than independent clinical efficacy studies typically associated with new drug applications or novel high-risk devices. Therefore, the information required for directly answering all parts of your request about acceptance criteria and a study proving the device meets the acceptance criteria in the context of an AI/algorithm-driven device is largely not present in this document.
Here's an analysis based on the provided text, focusing on what is available and explaining the gaps:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests conducted to demonstrate the device operates as designed and functions as intended, often in comparison to a predicate device.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Assembly Verification | Operates as designed |
| Leak Testing | Operates as designed |
| Canister Implosion Test | Operates as designed |
| Tubing Collapse Test | Operates as designed |
| Pull Off Force Testing | Operates as designed |
| Biocompatibility: | |
| Cytotoxicity (ISO 10993) | Passed |
| Intracutaneous Reactivity (ISO 10993) | Passed |
| Sensitization (ISO 10993) | Passed |
| Acute Systemic Toxicity (ISO 10993) | Passed |
| Tissue Viability: | |
| No adverse effect on adipose tissue | Found no adverse effect |
| Vacuum Withstand: | |
| Withstand 30 in/Hg vacuum | Canister able to withstand 30 in/Hg (for 18 in/Hg max use) |
Notes on "Acceptance Criteria" for this device:
- This is a physical medical device for collection of adipose tissue, not an AI or diagnostic algorithm. Therefore, the "acceptance criteria" are related to mechanical integrity, material safety, and functional equivalence to a predicate device, rather than diagnostic accuracy.
- The document states, "Performance testing has demonstrated that the subject device operates as designed and functions as intended." This general statement serves as the "reported performance" for the functional tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests (e.g., number of units tested for leak, implosion, etc.), nor does it mention data provenance in terms of country of origin or retrospective/prospective nature. This level of detail is typically not required nor provided in a 510(k) summary for this type of device.
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 and therefore not provided. The "ground truth" for a physical device like this is not established by human experts in the way it is for diagnostic algorithms. Instead, it's determined by engineering specifications and material science for the mechanical/biocompatibility tests, and potentially by laboratory analysis for tissue viability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and therefore not provided. Adjudication methods are relevant for subjective assessments or disagreements in diagnostic tasks (e.g., by experts for an AI model), not for objective physical device testing.
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 is not applicable and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic algorithms, often with human readers. The Red Head and Jordy Connection System is a physical device for tissue collection and is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable and therefore not provided. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the context of an AI algorithm based on expert consensus, pathology, or outcomes data is not directly applicable to this physical device.
The closest equivalent to "ground truth" for the performance tests would be:
- Engineering specifications/standards: For functional tests like implosion, leak, pull-off force.
- Standardized laboratory tests: For biocompatibility (ISO 10993) which involves specific in-vitro or in-vivo assays with established pass/fail criteria.
- Laboratory analysis of tissue samples: For tissue viability. The document states "Tissue viability testing found no adverse effect on adipose tissue with use of the subject device," implying laboratory assessment of the collected tissue.
8. The sample size for the training set
This is not applicable and therefore not provided. The device is a physical product, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable and therefore not provided.
In Summary:
The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through functional, mechanical, and biocompatibility testing. The questions regarding AI/algorithm performance metrics, expert adjudication, MRMC studies, and training/test sets for algorithms are not applicable to the information presented in this regulatory submission for "The Red Head and Jordy Connection System."
§ 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.