(28 days)
The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological surgery
- · Plastic and Reconstructive surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery
- · Thoracic Surgery
- · Wound Care
- · Laparoscopic Surgery
- · Thoracoscopic Surgery
The Ultrasonic Surgical Aspirator System (Model: XD880B) is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissues, and can also be used for precise cutting and shaping of bone tissue, using with the liguid-flow sleeve and liquid-flow tube. The product can be applied to a number of departments according to the suitable parameters and accessories, including:
- . Department of Neurosurgery, general surgery and other departments for soft tissue breakage and aspiration.
- Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
- . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
The Ultrasonic Surgical Aspirator System consists of a console, application software, foot switch, and accessories. The accessories include handpieces, tips, wrenches, liquid-flow sleeves, liquid-flow tubes, sterilization tray, suction canister and mobile cart. The handpiece, tip, liquid-flow sleeve and liquid-flow tube assemble to ultrasonic tool part to complete the cutting and fragment of soft tissue and bone tissue.
This looks like a 510(k) summary for an Ultrasonic Surgical Aspirator System (Model: XD880B) seeking to demonstrate substantial equivalence to a predicate device (K202299).
Here's an analysis based on your request, focusing on acceptance criteria and supporting studies. It's important to note that for a Class II device like this, the focus is often on demonstrating equivalence to an existing device rather than establishing novel clinical efficacy against specific, quantitative acceptance criteria in the same way a new drug or high-risk device might. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs at least as well as the predicate device, especially for any design changes.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the entire device. Instead, it describes changes from the predicate and then cites testing to show these changes do not negatively impact safety or effectiveness.
However, based on the non-clinical performance data section, we can infer some "acceptance criteria" related to the modifications:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Soft Tissue Protection in Bone Cutting Mode: Demonstrated effective protection of soft tissue. | "Safety and Performance Testing for Soft Tissue Protection in Bone Cutting Mode." (Successful performance implied) |
| Acoustic Performance for Modified Tips: Acoustic characteristics meet specifications. | "Acoustic Performance Testing for modified tips." (Performance meets specifications implied) |
| Cutting Efficiency for Modified Tips: Cutting efficiency is maintained or improved. | "Cutting Efficiency and Thermal testing Report for Modified Tips." (Efficiency maintained/improved implied) |
| Thermal Performance for Modified Tips: Thermal output remains within safe limits. | "Cutting Efficiency and Thermal testing Report for Modified Tips." (Safe thermal performance implied) |
| Overall Substantial Equivalence for Modified Tips: Modified tips are substantially equivalent. | "Comparison of Substantial Equivalence for Modified Tips." (Substantial equivalence demonstrated implied) |
Note: The document states, "the test results confirm that the performance specifications meets the modification inputs." This is the general statement of "acceptance," indicating compliance with internal specifications derived from the predicate's performance.
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 mentions "non-clinical tests" and "bench testing." It does not specify sample sizes for these tests, nor does it provide details on data provenance like country of origin or whether a "retrospective" or "prospective" design applies to bench testing (these terms are more relevant for human data). These are laboratory-based tests.
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 typically not relevant or included for non-clinical, bench testing of an ultrasonic surgical aspirator system. The "ground truth" for such tests would be measurable physical parameters (e.g., thermal output, acoustic frequency, cutting depth/speed) against established engineering specifications or comparisons to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies, especially those involving subjective interpretations (e.g., image reading, clinical outcomes). Since the testing described is non-clinical bench testing, this concept and information are not applicable or provided.
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
An MRMC study is not mentioned as this device is not an AI-powered diagnostic imaging tool requiring human interpretation. It is a surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an algorithm or AI without human involvement. The Ultrasonic Surgical Aspirator System is a physical surgical device, not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The device's performance is inherently linked to its physical operation properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned:
- Soft Tissue Protection in Bone Cutting Mode: The ground truth would likely be based on objective measurements of tissue damage or protection, adhering to predetermined safety thresholds.
- Acoustic Performance Testing for modified tips: The ground truth would be quantitative measurements of acoustic parameters (e.g., frequency spectrum, amplitude) compared to design specifications or predicate measurements.
- Cutting Efficiency and Thermal testing Report for Modified Tips: The ground truth would be objective measurements of cutting speed/volume and temperature generated during operation, compared against predicate performance or safety limits.
The "ground truth" is thus based on objective physical measurements and engineering specifications, rather than subjective human interpretation, pathology, or clinical outcomes data for these non-clinical tests.
8. The sample size for the training set
This question is applicable to machine learning or AI models. Since the device is a physical surgical tool and not an AI or machine learning system, there is no "training set."
9. How the ground truth for the training set was established
As there is no training set for an AI/ML model, this question is not applicable.
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