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The Lares Research Apex™ Electric Handpiece System ("System" defined as and limited to: A. Contra Angle Dental Instrument B. Electric Motor and C. Control System) device consists of a dental handpiece and accessories as listed in 21 CFR 872.4200, product code EKX that is a Class I, non-exempt hand-held device for dental drilling applications. This device is indicated for use where high speeds are required in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as cutting a tooth for caries, and/or crown preparation and finishing, cutting and/or finishing for dentures, denture bases, crowns, inlays and metal plates and/or root canal preparation for restoration. The device is also indicated for use in difficult to reach areas in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as the preparing dental caries for restorations, and for use at low speeds in teeth cleaning applications and dental surface polishing. The Apex™ Electric Handbiece System device is driven by an electronically controlled DC electric motor with a pneumatic/electronic actuated control system that is connected to the Contra Angle dental instrument via an ISO-3964 coupling. The Apex™ Electric Handpiece System device is indicated for use by dental professionals only.

The Apex™ Electric Handpiece System is a pneumatic/electronic controlled drive for dental drilling applications. The system consists of (3) components: A commercially-available electronic control system and electric motor and, Contra Angle dental instrument.
The Apex™ Electric Handpiece System consists of a console type desktop housing with the electronic microprocessor with integrated electric and pneumatic-electric controls, a high-torque motor sealed against lubrication from handpieces with removable motor sleeve and, Contra Angle dental instrument.
The Apex™ Electric Handpiece System uses a DC controlled micromotor as the driving element of the system, controlled by an electronic microprocessor that is actuated by the practicing dentist's existing air delivery system via foot pedal. Rotation of the dental instrument is controlled by the translation of air to electrical power wherein a wide range of speeds can be achieved and maintained resulting in a precise control of torque and light at the procedure site.

The provided text is a 510(k) summary for a dental handpiece system. It pertains to a device that is classified as Class I (general controls) and specifically states that no formal performance data was submitted. This means the document does not contain information about acceptance criteria or a study proving the device meets them in the way one might expect for a higher-risk device that relies on clinical or in-vitro performance studies.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices and adherence to relevant industry standards. The primary "test" described is a biocompatibility/cytotoxicity evaluation.

Here's an analysis based on your requested information, focusing on what is available and explicitly stating what is not available in this specific document:

Acceptance Criteria and Device Performance for Apex™ Electric Handpiece System

Based on the provided 510(k) summary, the primary area where specific "acceptance criteria" and "reported performance" are detailed is regarding biocompatibility/cytotoxicity. For other aspects, the device's acceptability is demonstrated through substantial equivalence to predicate devices and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • For the biocompatibility/cytotoxicity evaluation: Three (3) separate Lares Handpiece samples were tested.
  • For functional equivalence (comparison to predicate devices) and standards compliance: Not applicable in the same way as a clinical study. The device itself is the "test article" compared against specifications and predicate device characteristics.
• Data Provenance:
  • Biocompatibility/cytotoxicity evaluation: Conducted by Nelson Laboratories (Salt Lake City, UT). The report is dated June 19, 2003. This is an in vitro test.
  • Functional equivalence and standards compliance: Based on internal assessment by Lares Research, Inc. and comparison to publicly available information or specifications of predicate devices and standards. This is not "data provenance" in the clinical study sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Biocompatibility/Cytotoxicity: The ground truth (assessment of cellular destruction) was established by the Nelson Laboratories personnel conducting the in vitro MEM Elution test. The document does not specify the number or qualifications of these experts beyond stating the lab conducted the evaluation. It's a laboratory test with objective scoring criteria, rather than expert interpretation of complex clinical data.
• Functional Equivalence/Standards Compliance: The "ground truth" here is the established specifications of the device and the predicate devices, and the requirements of the standards. The comparison was performed by Lares Research, Inc., as part of their 510(k) submission. No external "experts" were explicitly mentioned for subjective "ground truth" establishment in this context.

4. Adjudication Method for the Test Set

• Biocompatibility/Cytotoxicity: The grading of cellular destruction (Grade 0) is based on a standardized and objective laboratory assay (MEM Elution). No explicit "adjudication method" (like 2+1 or 3+1 for expert review) is mentioned or likely relevant for this type of in vitro test. The result is a direct observation and scoring based on the test protocol.
• Other aspects: Not applicable as there isn't a "test set" requiring adjudication in the context of clinical or image-based studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This document pertains to a dental handpiece (a mechanical device), not an AI or imaging diagnostic tool. Therefore, discussions of human reader improvement with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, performance of an algorithm (standalone or otherwise) was not done. This document is for a physical dental handpiece system, not a software algorithm.

7. The Type of Ground Truth Used

• Biocompatibility/Cytotoxicity: Objective laboratory measurements/observations of cellular destruction in an in vitro MEM Elution test, scored based on established criteria for such assays.
• Functional Equivalence: Comparison against predicate device technical specifications and performance characteristics and recognized industry standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for this type of device submission. The device is a mechanical tool, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, there is no ground truth for it.

Summary:

This 510(k) submission for the Apex™ Electric Handpiece System primarily relies on demonstrating:

1. Biocompatibility through a specific in vitro cytotoxicity test on 3 samples, which showed no cellular destruction.
2. Substantial Equivalence to existing legally marketed predicate devices by comparing technical characteristics (design, speed, control, sterilization, etc.).
3. Compliance with recognized industry standards (ISO, IEC, FDA Guidance Standards).

The document explicitly states that "No formal performance data was submitted for this Class I device." This is typical for Class I devices where safety and effectiveness are largely demonstrated through adherence to general controls, standards, and substantial equivalence to market predecessors, rather than extensive clinical performance trials.

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