(337 days)
Piezomed is a piezoelectric ultrasonic device, consisting of handpieces and associated instruments, intended for:
- Bone Cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
- Scaling applications, including:
- o Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- o Endodontic: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha-condensation and retrograde preparation;
- o Restorative and Prosthetics: Cavity preparation, removal of prostheses, finishing of crown preparations.
Piezomed SA-320 is an ultrasonic drive unit intended for the treatment of organic hard and soft tissue in dental surgery, implantology, maxillofacial surgery and periodontics.
The device consists of the control unit, the foot control, the piezo handpiece incl. cable, an irrigation tubing set, the instrument set "Bone" and the corresponding instrument changer, and various accessories such as the stand and a motor rest.
The unit provides an instrument (tip) detection, choosing automatically the power class fixed for the attached instrument (tip). Within certain limits the user can change the pre-adjusted power settings manually. Furthermore, the user can choose between three adjustable working modes (Power, Basic, Smooth). A boost function enables a short-term power increase by 20 %. A LED lighting ring provides illumination of the surgical site.
This document is a 510(k) submission summary for a medical device and thus does not include the detailed study protocols, criteria, or results that would be found in a clinical trial report. The information provided is primarily to demonstrate substantial equivalence to a predicate device, not to prove defined acceptance criteria through a specific study in the way typically found for an AI/ML device.
However, based on the provided text, I can extract information related to performance testing that served to demonstrate the device met regulatory requirements for substantial equivalence.
Here's an interpretation based on the provided document:
Acceptance Criteria and Reported Device Performance
The document describes the Piezomed SA-320 as a revised and improved version of a predicate device (Piezosurgery Touch, K122322). The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device by meeting relevant performance standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Electrical Safety (compliance with IEC 60601-1:2005) | Compliant: Electrical Safety Tests according to IEC 60601-1:2005 were performed. |
| Electromagnetic Compatibility (EMC) (compliance with IEC 60601-1-2:2007) | Compliant: Electromagnetic Compatibility Test according to IEC 60601-1-2:2007 was performed. |
| Mechanical Strength (compliance with ANSI/AAMI ES 60601-1:2005) | Compliant: Mechanical strength test according to ANSI/AAMI ES 60601-1:2005 was performed. |
| Dental Handpiece Performance (compliance with ISO 22374:2005) | Compliant: Type testing according to ISO 22374:2005: Dentistry -- Dental handpieces -- Electrical-powered scalers and scaler tips was performed. |
| Software Validation (compliance with IEC 62304:2006) | Validated: Software validation according to IEC 62304:2006: Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software was performed. |
| Usability Validation (compliance with IEC 62366:2007) | Validated: Usability validation according to IEC 62366:2007 was performed. |
| Thermal Safety (compliance with IEC 62471:2006) | Compliant: Thermal safety according to the standard IEC 62471:2006: Photobiological safety of lamps and lamp systems was performed. |
| Performance Parameters (Flow Rate, Biocompatibility, Sterilizability, Functionality, Lifecycle) | Demonstrated: Flow rate testing, evaluation of biocompatibility and sterilizability, various functionality and lifecycle tests as well as further bench tests were performed to demonstrate substantial equivalence. |
Specific parameters include:
- Mains supply: 100 – 240 V / 50-60Hz (matches predicate)
- Max. power consumption: 90 VA (vs. 120 VA for predicate)
- Operating frequency: Automatic scan, from 24 KHz to 32 KHz (vs. 24 KHz to 36 KHz for predicate)
- Coolant flow rate: at least 50 ml (vs. max. 75 ml for predicate)
- LED system: 4 LEDs (vs. 1 LED for predicate)
- Cleaning/Sterilization: Thermo washer disinfection approved, Steam sterilization at 132°C (270°F) (matches predicate)
- Autoclaveability: Handpiece and blank/polished instruments/tips 132°C (270°F) for 4 minutes with drying time (matches predicate). Diamond coated instruments/tips: Single-use only (matches predicate).
- Range of instruments/tips: 24 variants (vs. 31 for predicate)
- Materials of the instruments/tips: Stainless steel – polished or diamond-coated (matches predicate) |
Study Details:
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Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of data for an AI/ML algorithm. The performance testing described refers to physical device testing according to established standards. For these tests, the sample size would typically refer to the number of devices or components tested. This information is not provided in the summary.
- Data Provenance: Not applicable, as this is related to physical device testing, not data-driven algorithm validation.
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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 as this is a traditional medical device (piezoelectric ultrasonic device), not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests are the objective measurements from the standards and physical properties.
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Adjudication method for the test set:
- Not applicable for the same reasons as above. Testing involved adherence to published international standards for medical devices.
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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, an MRMC comparative effectiveness study was not done. This device is not an AI/ML enabled device designed to assist human readers or clinicians in interpreting images or data. It is a surgical tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical, human-operated medical tool, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing cited is adherence to objective criteria and methodologies outlined in recognized international standards (e.g., IEC 60601-1, ISO 22374). This is physical and electrical property testing against defined limits, not expert judgment on medical data.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as above.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.