(148 days)
Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.
Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.
PIEZOTOME M+ is an Electromedical Device that uses micro-vibrations of associated Tips, to perform the clinical procedures defined in Intended Use.
PIEZOTOME M+ consists of a Console, a Multifunction footswitch, two reusable Handpieces, a range of Dental Tips, a range of Bone Surgery Tips, two Irrigation tubings and Flat Wrenches for Tips.
The Console is the heart of the PIEZOTOME M+. The Console contains the display board and the motherboard. Ultrasonic Handpieces and Footswitch are connected to the LCD Color Touch screen present on the front panel is used to define the settings of the PIEZOTOME M+ (modes, ultrasonic power, irrigation flow values).
The Multifunction footswitch has different functions. The access to a number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of crosscontamination. The Footswitch is classified IP X8 (Protective Index) for operating theater applications.
The Ultrasonic Handpieces are held in the Surgeron's hand. The Ultrasonic Handpieces are connected to the Console via a Handpiece Cord. A Handpiece is dedicated to Conventional dental procedures (NEWTRON LED Handpiece) and a Handpiece is dedicated to Bone Surgery procedures (PIEZOTOME M+ Handpiece). The Ultrasonic Handpieces are equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical microvibrations. The Ultrasonic Handpieces are reusable and Sterilizable by autoclaving.
The Pump housings are designed to accommodate Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the clinical site and eliminate by rinsing the fragments such as bone or teeth.
Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpieces. Tips are in direct contact to the patient. The ultrasonic mechanical vibrations transmitted to the Tip permits the realization of the clinical procedures defined in Intended Use. Bone Surgery Tips are Single Use and delivered under Sterile State. Dental Tips are reusable.
The provided document is a 510(k) Premarket Notification for a medical device called PIEZOTOME M+, issued by the FDA. It declares the device to be "substantially equivalent" to legally marketed predicate devices.
This document describes a medical device (PIEZOTOME M+, an ultrasonic surgical system) and its performance data to demonstrate substantial equivalence to existing devices. Therefore, the questions related to acceptance criteria and study design for an AI/algorithm-based device (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable to this document.
The "performance data" discussed in the document refers to typical engineering and safety tests for a physical medical device, not an AI/algorithmic system. The information provided is about electrical safety, electromagnetic compatibility, software verification (specifically stating the software is identical to a predicate device, not a new algorithm), and performance testing bench (meaning physical tests to confirm the device functions as intended, not AI model performance).
Here's how the provided information relates to the request, focusing on what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical format for an AI/algorithm where specific metrics (e.g., accuracy, sensitivity, specificity) and thresholds are defined. Instead, it demonstrates equivalency through a comparison of technological characteristics and verification against established electrical and safety standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) | Reported Device Performance |
|---|---|
| Electrical Safety: Compliance with IEC 60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), including USA and Canadian Deviations. | "The Electrical Safety Tests have been performed according to IEC 60601-1:2005... included USA and Canadian Deviations." |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests). | "The Electromagnetic Compatibility Tests have been performed according to IEC 60601-1-2:2007..." |
| Software Verification & Validation: Adherence to "Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). | "Software Verification activities were conducted and documented according to the document named 'Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' dated May 11, 2005. Moreover, the Software System included in PIEZOTOME M+ is strictly the same Software as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009)." |
| Performance (Physical Device Function): Similar technical characteristics for bone surgery and dental applications (piezoelectric and irrigation performance) to predicate devices. | "The Technical Characteristics for Bone Surgery Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Devices Piezoelectric System (K100410, cleared April 28, 2010) and PIEZOTOME 2 (K091331, cleared December 11, 2009). The Technical Characteristics for Dental Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009)." |
| Sterilization Validation: Compliance with applicable standards for reusable and single-use accessories. | "The Sterilizability Tests have been performed according to applicable Standards for Re-Usable accessories and Single Use Accessories provided under Sterile State." |
| Biocompatibility Validation: Compliance with ISO 10993-1 and 510(k) Memorandum - #G95-1 Table 1 requirements for body contact. | "The Biocompatibility Tests have been performed according to applicable Standards for Accessories in contact to the Patient. Tests were conducted according to the ISO 10993-1 Standard and 510(k) Memorandum - #G95-1 Table 1 'Initial Evaluation Tests for Consideration requirements (Body Contact: External communicating Device - Type of Tissue / Bone Dentin Communicating - Contact Duration: A limited less than 24 hours)." |
| Similarity to Predicate Devices: Overall technological characteristics being similar or identical to predicate devices. | A comprehensive comparison table (Table 02 on pages 5-9) is provided, detailing numerous identical or substantially equivalent characteristics across various categories (intended use, product codes, dimensions, power supply, safety classifications, internal/external constitution, software, piezoelectric performance, irrigation performance, user interface, footswitch, environmental conditions, handpieces, tips, sterilization, biocompatibility, safety/EMC standards). Minor differences (e.g., footswitch actuators, storage temperature range, specific tip designs, handpiece color) are explicitly stated to have "no impact" on substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document pertains to a physical medical device. The "performance data" refers to engineering and safety tests of the device itself and its components (e.g., electrical safety, EMC, sterilization, biocompatibility), not an AI/algorithm dataset. There is no mention of a "test set" in the context of data used for an algorithm.
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)
- Not Applicable. This document does not describe an AI/algorithm that requires expert-established ground truth from medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- Not Applicable. This is not an AI-assisted diagnostic or clinical decision support device. It's an ultrasonic surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no standalone algorithm. The "software" mentioned is identical to a predicate device's software, suggesting a control system for the physical device, not an analytical algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., IEC, ISO) and benchmarks against predicate devices' physical characteristics and function.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.