(51 days)
The Accelerator Reciprocating Cannula indications for use are the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
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The provided documents pertain to the FDA 510(k) clearance for the Accelerator Reciprocating Cannula by Byron Medical. This is a medical device submission, specifically a predicate comparison, not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or performance study against specific metrics.
Therefore, I cannot provide the information requested in the format of acceptance criteria and the study that proves the device meets them, as this document type does not contain such a study or detailed performance metrics.
However, I can extract the information that is present, focusing on the comparative effectiveness study (which is a comparison to predicate devices for substantial equivalence, not a clinical trial proving new acceptance criteria).
Here's a breakdown of what can be extracted or inferred from the provided FDA 510(k) summary regarding the requested points:
1. A table of acceptance criteria and the reported device performance
The document does not establish explicit "acceptance criteria" for the Accelerator Reciprocating Cannula in the way a clinical performance study would. Instead, it demonstrates substantial equivalence to legally marketed predicate devices. The "performance" is reported within a comparative table against these predicates on certain functional attributes.
| Criteria (Functional Attribute for Substantial Equivalence) | Reported Device Performance (Byron Medical Accelerator Reciprocating Cannula) | Predicate Device 1 (MicroAire PAD system) Performance | Predicate Device 2 (Byron Medical - Traditional Cannula) Performance (Manual) |
|---|---|---|---|
| Rate of Movement | 0-800 cpm – adjustable | 0 and 4,000 cpm non adjustable | 0 - 250 cpm (based on physician stroke length; not easily maintainable) |
| Distance Travels | 0, ¼" and ½" | 0, 1/10" and ¼" | 0 - 12"+ |
| Cannula Attached (Size/Diameter) | 2-6mm | 3.9-5mm | 2-6mm |
| Force (during operation) | 41 lbs of force (with safety mechanism that stops reciprocation if > 41 lbs) | 60+ lbs of force (can be overcome by physician) | 50+ lbs of force |
| Safety Feature | Reciprocation stops when > 41 lbs of force is applied. | None explicitly mentioned | None explicitly mentioned |
| Overall Summary of Equivalence | "as safe as the Existing Modalities with An additional safety feature" |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of a clinical test set. The submission focuses on a comparison of device specifications and operational characteristics to predicate devices. No human subject testing data (test set) is provided or referenced here.
- Data Provenance: The data is a comparison of technical specifications and operating parameters, likely derived from engineering testing, functional analysis, and manufacturer specifications of the Byron Medical device and its predicate devices. No country of origin for a "test set" or information about retrospective/prospective collection is relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. There was no "test set" in the sense of patient data or images requiring expert adjudication. The "ground truth" for this type of submission is the documented performance characteristics of the devices and their equivalence.
4. Adjudication method for the test set
- Not applicable, as there was no test set requiring adjudication.
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. The device (Accelerator Reciprocating Cannula) is a surgical instrument (a cannula for liposuction), not an AI-powered diagnostic imaging device. Therefore, no MRMC study involving human readers or AI assistance was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical surgical instrument, not an algorithm or AI system.
7. The type of ground truth used
- For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on the technical specifications, functional performance characteristics, and intended use comparison of the proposed device against legally marketed predicate devices. This includes physical measurements, operational parameters (e.g., cpm, travel distance, force), and safety features, substantiated through engineering and non-clinical testing data (not provided in detail in this summary) and comparison with predicate device information.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. No training set exists 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.