Search Results

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:

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.

Ask a specific question about this device

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 XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:

• . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, 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 XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.

This document describes the FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System (XD880B), focusing on its substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria.

Therefore, the specific information requested, such as a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone algorithm performance, is not present or applicable in the provided document.

The document details the device's technical specifications and non-clinical performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance:

• Not applicable in the context of this document. This document focuses on demonstrating substantial equivalence based on technical characteristics and non-clinical testing, not on achieving specific clinical performance metrics against predefined acceptance criteria from a clinical trial.
• The "performance" described is in terms of passing various non-clinical standard tests (e.g., electrical safety, EMC, software verification, sterilization validation, shelf-life, lifetime validation, acoustic performance, efficiency and temperature characteristics).

2. Sample sizes used for the test set and the data provenance:

• Not applicable. This submission relies on non-clinical testing and comparison to predicate devices, not on a clinical test set in the way a diagnostic AI would.
• The document implies that various units of the device and its components were tested to meet the specified non-clinical standards, but explicit "sample sizes" for a clinical test set are not mentioned as no clinical performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical ground truth establishment involving human experts is described. The "truth" for this submission is based on engineering standards and technical specifications.

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

• Not applicable. No clinical test set requiring adjudication is described.

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. A MRMC study was not conducted as this is an ultrasonic surgical aspirator system, not a diagnostic AI system designed to assist human readers.

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

• Not applicable. This device is a surgical tool, not a standalone diagnostic algorithm. Its function inherently involves human operation.

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

• Technical Specifications and Standard Compliance: The "ground truth" for this submission is adherence to engineering specifications and compliance with international and national standards for medical devices (e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 62304 for software, ISO 17665-1 and ISO 11135 for sterilization). The device's performance is measured against these established technical benchmarks.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not an AI/ML model that requires a "training set" in the computational sense.

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

• Not applicable. See point 8.

Summary of Device Acceptance (from the document's perspective):

The acceptance mechanism for this device's FDA clearance is "Substantial Equivalence" to legally marketed predicate devices. This is achieved by demonstrating that the new device:

• Has the same intended use.
• Has the same or similar indications for use.
• Has the same or similar technological characteristics.
• Does not raise new or different questions of safety or effectiveness.

Studies/Data that Proved Device Meets "Acceptance Criteria" (i.e., Substantial Equivalence):

The document states that the following non-clinical tests were conducted and passed to support substantial equivalence:

• Electrical safety testing per IEC 60601-1
• EMC testing per IEC 60601-1-2
• Software verification and validation per IEC 62304 / FDA Guidance
• Moist heat sterilization validation per ISO 17665-1
• EO sterilization validation per ISO 11135 (demonstrates SAL of 10^-6)
• Shelf-life Testing
• Lifetime validation test for handpieces
• Acoustic Performance Test per IEC 61847
• Efficiency and Temperature Characteristics Test

These tests confirm that the device's design inputs and performance specifications are met, allowing the FDA to determine that it is as safe and effective as the predicate devices, thereby meeting the "acceptance criteria" for 510(k) clearance by way of substantial equivalence.

Ask a specific question about this device

Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:

• Otolaryngology
• Oral/maxillofacial
• Hand and foot
• Neurosurgery
• Spine
• Plastic/reconstructive.

Ultrasonic Osteotomy Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the cutting tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude.

Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of cutting tips, wrench and torque wrench, a foot switch and irrigation set (liquid-flow tube and liquid-flow sleeve).

The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition.

The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.

The provided text describes an Ultrasonic Osteotomy Surgical System and its 510(k) summary for FDA clearance. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically understood for AI/ML performance (e.g., accuracy, sensitivity, specificity, or human reader improvement) does not apply directly in this context.

Instead, for this type of device (an ultrasonic surgical system), "acceptance criteria" relates to demonstrating that the new device is as safe and effective as its predicate device. This is primarily done through non-clinical performance data (bench testing) and demonstrating substantial equivalence in design, materials, and intended use. Clinical studies for performance improvements relative to human readers or AI algorithms are not relevant to this device type or regulatory pathway.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the AI/ML sense, nor information on sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the information provided in the document for this specific medical device.

However, I can extract what the document presents as evidence for "meeting acceptance criteria" in the context of a medical device 510(k) submission, focusing on Non-Clinical Performance Data and Substantial Equivalence.

1. "Acceptance Criteria" (in the context of a 510(k) for this device) and Reported Device "Performance":

For this device, "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and showing that differences do not raise new questions of safety and effectiveness, supported by non-clinical testing. The "reported device performance" is the successful outcome of these non-clinical tests, showing the device operates within expected parameters and safely.

• Same manufacturer, composition, indications for use, user interface, ultrasonic vibration activation, tip material, frequency, maximum flow, ultrasound output mode, electrical safety classification, power supply, power cord length, and operating/shipping/storage conditions.
• Minor differences (irrigation system pump placement, wrench type, sterilization method) are discussed and deemed to not impact safety or effectiveness. |
  | Sterilization Efficacy and Shelf Life | Single Use Disposable Components: EO sterilization validation tests for sterile package, sterile barrier testing, device performance testing on sterilized components, simulated shipment testing, accelerated and natural aged testing to support claimed shelf life.
  Reusable Components: Cleaning and sterilization testing performed for each reusable component (moist heat). |
  | Functional / Bench Performance | Successful completion of:
• Ultrasound Performance Testing
• Irrigation Performance Testing
• Cutting Efficiency and Thermal Testing
• Mechanical Testing for Torque Wrench |
  | Safety and Effectiveness | "Safety and performance testing have demonstrated the Ultrasonic Osteotomy Surgical System is as safe and effective as the predicate device." |

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in terms of patient data. The testing is primarily bench testing and validation studies for sterilization, shelf-life, and functional performance. It would involve specific numbers of device units or components tested to statistical significance, but these specifics are not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data. For non-clinical validation, the testing was performed by SMTP Technology Co., Ltd. in China. The data would be prospective in the sense that the tests were specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device revolves around objective engineering and performance specifications (e.g., frequency output, flow rate, sterilization efficacy, cutting efficiency) which are measured against established physical standards and predicate device performance characteristics, not expert consensus on medical images.

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

• Not applicable. This is not a study involving human reader interpretation or clinical 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:

• No, a MRMC comparative effectiveness study was not done. This device is an ultrasonic surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

• No, this device is not an algorithm. It is a physical surgical system. "Standalone performance" in this context refers to the device's functional performance metrics (e.g., frequency output, flow rate, cutting ability) which are detailed as "Non-Clinical Performance Data."

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

• The "ground truth" for this device's performance validation is based on engineering specifications, international standards (e.g., for sterilization), and direct comparison to the physical and functional characteristics of the predicate device. It relies on objective quantitative measurements (e.g., 39 kHz±4kHz frequency, 120ml/min±20% flow rate) and validated processes (e.g., EO sterilization efficacy). It does not involve medical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

Ask a specific question about this device