(104 days)
The Maxima XTEND Handpiece Maintenance System is intended for cleaning and lubrication of dental Handpieces including air turbines, air motors and air driven scalers prior to sterilization.
Maxima XTEND Handpiece Maintenance System is a complete automatic dispensing system for cleaning: lubrication and purging old oil for dental handpieces prior to sterilization cvcles.
User can use push button kev pad to select time for purqing lubricant into handpiece including 15 seconds, 20 seconds, and 30 seconds. In addition, there are 11 adjustable settings for the amount of lubricant into the handpiece; user can choose the amount of lubricant to purge into handpieces accordingly. The system can maintenance up to 3 handpieces at the same time, and an unique chuck care nozzle to lubricate chucks in dental turbines.
Service Maxima XTEND Handpiece maintenance system is capable to operate with aerosol lubricant can with or without compressed-air supply. Air pressure will deliver Lubricant directly through internal parts of handpieces and contra angles by the controlling of software to open and close magnetic valves. The system will purge all the excess lubricant. The provided linen pads and removable trays on front side and bottom of the system will absorb the excess liquid of lubricant.
Lubricant uses for the Maxima Handpiece Maintenance System is aerosol spray can "Maxima Handpiece Cleaner & Lubricant" has been previous cleared with 510(k) # K113674
The Maxima XTEND Handpiece Maintenance System contains following main components:
- Main case 1
- Rear case
- Front door module
- 4 PCBA board
- 5 Power supply
- 6 Adapters module
- 7 LCM Module
- 8 Oil supply module
- Solenoid valve
- 10 Rear components module
- 11 Back plate cover
- 12 Top cover
- 13 Veneer (Bright Blue)
- 14 Oil trav
- 15 Rotation motor module
The provided document describes the Maxima XTEND Handpiece Maintenance System, a device for cleaning and lubricating dental handpieces. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense of a pass/fail metric for device performance against specific thresholds. Instead, it presents a comparison table of features with a predicate device and then discusses performance testing to demonstrate similarity.
Comparison Table (based on features and "performance testing" section):
| Feature/Metric | Acceptance Criteria Implied (from Predicate) | Maxima XTEND Performance | Met/Not Met |
|---|---|---|---|
| Cleaning & Lubrication Effectiveness | No significant change in handpiece performance (speed, torque, bur extraction force, concentricity) after 250 cycles. | No significant changes in speed, torque, bur extraction force, and concentricity after 250 cycles. Lubrication performance similar to predicate. | Met (implied) |
| Number of Connections | 4 | 4 | Met |
| Built-in Chuck Adaptor | Yes | Yes | Met |
| Cycle Times to Lubricate Handpiece | 15 Seconds (Predicate) | 15, 20, 25 seconds programmable | Met (and exceeds) |
| Lubricant Change Indicator | Yes | Yes | Met |
| Lubricant Containment | Aerosol can | Maxima Handpiece Cleaner & Lubricant - Aerosol can (K113674) | Met |
| Compressed Air | 58-87 psi. | 58-87 psi. | Met |
| Air Consumption | 40 NL/min | 40 NL/min | Met |
| Dimensions | 285x190x400 mm (11.2 x 7.5 x 15.8 in.) | 295x385x295 mm (11.6 x 15.15 x 11.6 in.) | Met (comparable) |
| Weight | 8.6 Kg (18.96 Lbs.) | 9.0 Kg (19.8 Lbs.) | Met (comparable) |
| Warranty | 10 Years (Predicate) | 5 years | Not Met (inferior to predicate, but may not be an "acceptance criterion" for safety/effectiveness) |
Study Proving Acceptance Criteria:
The study proving the device meets the functional "acceptance criteria" (i.e., that it effectively cleans and lubricates handpieces without degrading performance) is described as "product testing results in attachment 3" (which is not included in the provided text).
The document states: "Based on product testing results in attachment 3: there are no significant changes in performance of testing handpieces after 250 cycles of testing by using Maxima XTEND and STAMATIC 31 Handpiece Maintenance Unit. The performance of these handpieces including speed, torque bur extraction force and concentricity which do not change significantly compared from the beginning of the test to the end result of the performance testing. The lubrication performance of Maxima XTEND Handpiece Maintenance System on the testing handpieces is similar to lubrication performance of the STATMATIC 31 Handpiece Maintenance Unit on the testing handpieces."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "testing handpieces" and "250 cycles of testing." It does not specify the number of individual handpieces tested. It only refers to "these handpieces" in a general sense.
- Data Provenance: Not explicitly stated, but it would be prospective testing conducted by the manufacturer ("Handpiece Headquarters"). No country of origin for the data is mentioned, but the company is based in Placentia, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance testing appears to be objective, measuring physical parameters of the handpieces (speed, torque, bur extraction force, concentricity) directly, rather than relying on expert assessment of an outcome.
4. Adjudication Method for the Test Set
Not applicable, as ground truth was established by direct measurement of physical properties, not by expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an MRMC study. The study compares the performance of the device itself to a predicate device, not human reader performance with or without AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, this is essentially a standalone (device-only) performance study, comparing the Maxima XTEND Handpiece Maintenance System's effect on handpieces to that of the predicate device. There is no human intervention in the operation being evaluated beyond starting the device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the performance study was based on objective physical measurements of dental handpiece performance parameters:
- Speed
- Torque
- Bur extraction force
- Concentricity
The baseline measurements "from the beginning of the test" served as the initial ground truth for each handpiece, against which "the end result of the performance testing" was compared after 250 cycles.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical cleaning and lubrication system, not an AI or algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.