(290 days)
The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.
SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use.
PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece.
The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values).
The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving.
Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip.
The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.
The provided text is a 510(k) Summary for the PIEZOTOME CUBE, an ultrasonic surgical system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for clinical efficacy. Therefore, much of the requested information regarding an acceptance criteria table, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, multi-reader multi-case studies, and specific ground truth types for a clinical performance study cannot be found or directly inferred from the provided text.
The document primarily relies on comparisons of technical characteristics and performance testing to the predicate device, PIEZOTOME SOLO.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with corresponding performance results for clinical efficacy. Instead, it compares the technical characteristics and performance of the PIEZOTOME CUBE to its predicate device, PIEZOTOME SOLO, arguing that the differences have no impact on safety or effectiveness.
Below is a summary of the technical performance comparisons, which serve as the "reported device performance" in the context of demonstrating substantial equivalence, effectively meeting the "acceptance criteria" of being similar to the predicate.
| Feature / Characteristic | PIEZOTOME CUBE (New Device) | PIEZOTOME SOLO (Predicate Device #1 - K112188) | Impact of the differences on Safety / Effectiveness |
|---|---|---|---|
| Indications for Use | Consistent with predicate | The intended use of the SATELEC PIEZOTOME SOLO... is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners. | Similar to PD#1 - No Impact |
| Intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology. | The PIEZOTOME SOLO is a device designed to perform dental surgery including osteotomies, osteoplasties, periodontal and implant surgery. | Similar to PD#1 - No Impact | |
| Principle of Operation | An electrical signal supplied to the dental piezo-ultrasonic Handpiece, comprising a piezoelectric ceramic transducer converting electrical signal into ultrasonic vibrations. | Identical (Principle is described, assumed identical as "No Impact" stated for this category) | Identical to PD#1 - No Impact |
| Dimensions (Console) | Height: 160 mm, Depth: 271 mm, Width: 251 mm, Weight: 3.5 kg | Height: 136 mm, Depth: 306 mm, Width: 378 mm, Weight: 3.7 kg | No Impact |
| Power Supply | 100-230 VAC, 50/60 Hz, 150 VA | 100-230 VAC, 50/60 Hz, 150 VA | Identical to PD#1 - No Impact |
| Electrical Safety | Class 1, BF Type | Class 1, BF Type | Identical to PD#1 - No Impact |
| Piezoelectric Performances (Output Ultrasonic frequency) | 28 to 36 kHz | 28 to 36 kHz | Identical to PD#1 - No Impact |
| Available Modes | D1/ D2 / D3 / D4 | D1/ D2 / D3 / D4 | Identical to PD#1 - No Impact |
| Nominal Output Current (D1, D2, D3, D4 modes) | 215.3 mA, 171.2 mA, 123.9 mA, 120.8 mA | 215.3 mA, 171.2 mA, 123.9 mA, 120.8 mA | Identical to PD#1 - No Impact |
| Frequency Modulation (D1-D3) | 60 Hz | 60 Hz | Identical to PD#1 - No Impact |
| Frequency Modulation (D4) | 30 Hz | 30 Hz | Identical to PD#1 - No Impact |
| Irrigation Performances (Pump, Off, Min, Max Flow Rate) | 1 pump, 0 ml/min, 10 ml/min, 120 ml/min | 1 pump, 0 ml/min, 10 ml/min, 120 ml/min | Identical to PD#1 - No Impact |
| User Interface for Setting | Sensitive areas on front panel (LED) | Keys on front panel (Monochrome LCD) | No Impact (considered a minor change with no impact on safety/effectiveness) |
| Environmental (Storage Temperature) | 0 to +50 °C | -20 to +70 °C | No Impact |
| Handpieces | CUBE LED Handpiece | PIEZOTOME SOLO Handpiece | No Impact (difference in specific handpiece model, but technology and function are similar) |
| Biocompatibility Material (Handpiece) | Polyphenylsulfone (PPSU) used in Medical Application | Polyphenylsulfone (PPSU) used in Medical Application | Identical to PD#1 - No Impact |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Identical to PD#1 - No Impact |
| Sterilization Validation | Per ISO 17665-1, ISO 17665-2, AAMI ST55, AAMI TIR 30 | N/A (implied met by predicate) | Validated for new device |
| Cleaning Validation | Per FDA Guidance "Reprocessing Medical Devices..." | N/A (implied met by predicate) | Validated for new device |
| Software V&V | Per "Guidance for Industry and FDA Staff..." | N/A (implied met by predicate) | Validated for new device |
The acceptance criterion, in essence, is that the new device's performance is either identical to the predicate or that any differences have no impact on safety or effectiveness.
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 refers to "Performance Testing bench" and various validation tests (Electrical Safety, EMC, Software V&V, Sterilization, Cleaning, Biocompatibility). These are bench tests or validation processes, not clinical studies with human patient data or specific "test sets" in the context of AI/ML performance evaluation. Therefore, sample size and data provenance (country, retrospective/prospective) in the clinical sense are not applicable here.
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 not provided. The device is a physical ultrasonic surgical system, not an AI/ML diagnostic tool that requires ground truth established by medical experts for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to expert consensus for ground truth establishment in studies involving interpretation, which is not the case for this device.
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 such study was mentioned or performed, as the PIEZOTOME CUBE is a surgical tool, not an AI-assisted diagnostic or interpretation system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is an ultrasonic surgical system, not an algorithm. Performance testing was primarily bench testing and direct comparison to a predicate device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth in the context of this submission refers to the established technical specifications and performance characteristics of the predicate device, as well as compliance with recognized standards (e.g., IEC 60601-1, ISO 10993-1). For the validation tests performed (sterilization, cleaning, biocompatibility), the "ground truth" would be the successful adherence to the requirements of the specified standards and guidance documents. There is no mention of clinical outcome data or pathology reports for ground truth.
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.
§ 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.