(262 days)
Ultrasonic 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 Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve).
The console has a touch panel that allows the surgeon to control device operation. The console activates and controls the ultrasound vibration, controls irrigation flow, and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module, and the micro-processor electronic board that controls and supervises the functional parameters of the device.
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 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.
Ultrasonic 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 tip insert.
The tips are used to fragment and reshape bone and soft tissue through longitudinal and (for bone drilling) rotational vibration at high frequency and small amplitude, while keeping the soft tissues with elastic properties free of damage.
Ultrasonic Surgical System comes with separate handpieces for Ultrasonic Surgical Bone Cutting and Ultrasonic Surgical Bone Drilling.
The handpieces are reprocessed through cleaning and disinfection before each use. The ultrasonic tips, irrigation tubing, and water injection sleeves are provided sterile for single use.
The provided text is a 510(k) summary for the MediSonic Technology Co's "Ultrasonic Surgical System." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria for device performance in a clinical or AI-assisted context.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them in the context of device performance as understood in questions 1-9 (e.g., accuracy, effect size with human readers, standalone performance, ground truth establishment). The document describes non-clinical bench testing for aspects like electrical safety, biocompatibility, sterilization, and software validation, which are about assuring the device itself is safe and functions as designed, not about its clinical efficacy or how it assists human users.
Here's what can be extracted based on the provided text, addressing the points where information is available or noting its absence:
Acceptance Criteria and Device Performance (Based on "Performance Testing" section):
The document lists various non-clinical bench tests performed according to FDA-recognized standards. The description states that "the device passed each test." This implies that the acceptance criterion for each of these tests was simply compliance with the respective FDA-recognized standard. The "reported device performance" is implicitly that it met these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1-2 Edition 4:2014 (EMC) | Passed |
| Compliance with IEC 60601-1:2015, Mod (Electrical Safety) | Passed |
| Compliance with ISO 10993-1:2009 (Biocompatibility) | Passed (materials biocompatible) |
| Compliance with ISO 10993-5:2009 (Biocompatibility - Cytotoxicity) | Passed |
| Compliance with ISO 10993-10:2009 (Biocompatibility - Irritation/Sensitization) | Passed |
| Compliance with ISO 10993-7:2008 (Biocompatibility - EO residuals) | Passed |
| Compliance with ISO 10993-11:2017 (Biocompatibility - Systemic Toxicity) | Passed |
| Compliance with ISO 11135:2007 (Sterilization Validation) | Passed |
| Compliance with ISO 11607-1:2006 (Sterilization Packaging) | Passed |
| Compliance with ISO 11607-2:2006 (Packaging Validation) | Passed |
| Compliance with ASTM F1980-16 (Shelf Life) | Passed (2 Years) |
| Compliance with IEC 62366-1:2015 (Usability Engineering) | Passed |
| Compliance with IEC 61847:1998 (Ultrasonic Surgical Systems performance) | Passed |
| Compliance with IEC 62304:2006 (Software Life Cycle) | Software verification and validation reports included |
| Compliance with ISO 14971:2007 (Risk Management) | Passed |
Here's a breakdown of the specific questions based only on the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: As detailed in the table above, the acceptance criteria were compliance with the specified FDA-recognized standards for non-clinical bench testing.
- Reported Device Performance: The document states that "the device passed each test" and that "all necessary testing has been performed and the results support the conclusion that Ultrasonic Surgical System is substantially equivalent."
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Sample sizes used for the test set and the data provenance:
- This document describes non-clinical bench testing (e.g., electrical, biocompatibility, sterilization, software validation). It does not involve a "test set" in the sense of patient data or clinical images.
- Sample size: Not applicable for this type of testing (no human or patient data samples).
- Data provenance: Not applicable. The tests are laboratory-based demonstrations against engineering and safety standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of clinical device performance, usually refers to a definitive diagnosis or outcome confirmed by expert consensus, pathology, or long-term follow-up. This document focuses on demonstrating the safety and fundamental functionality of the surgical system itself through non-clinical testing, not diagnostic or clinical accuracy.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of human adjudication for a test set.
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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. This device is an "Ultrasonic Surgical System" for cutting bone, osteotomy, osteoplasty, and drilling. It is a surgical tool, not an AI-powered diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware surgical device, not a standalone algorithm. Its "performance" refers to its physical and functional capabilities, not an algorithmic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the tests performed relates to compliance with engineering and safety standards rather than clinical outcomes. For example, for biocompatibility, the ground truth is whether the materials elicit specific biological responses as defined by ISO standards. For electrical safety, it's whether the device meets insulation and leakage current limits. This is established by specific test methodologies outlined in the referenced standards.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML product developed with a training set.
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How the ground truth for the training set was established:
- Not applicable.
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