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This device is intended for use in general dentistry and restorative dentists and dental professionals in a dental office.

The Lares Research Perceptive electrical motor and control is an air-to-electric dental unit for use in dental restoration and prophylaxis procedures. The unit includes a power supply, control unit, user display tablet, hose and a brushless motor. The control unit is programmable to adjust motor speed, motor direction, and light intensity. The inputs to the control unit are supplied by an electronic tablet which is connected to the unit via a USB cable. The electronic tablet Perceptive application accepts both finger touch and a limited set of voice commands. The motor speed can also be controlled via the pneumatic footswitch connected to the control unit. The unit is designed to control the motor to drive ISO 3964 compatible contra angle and straight dental handpieces at an output speed of 1,000 to 40,000 rpm.

The provided text describes a 510(k) premarket notification for a dental device, focusing on its substantial equivalence to a predicate device. It includes some information about nonclinical tests but does not detail acceptance criteria or a comprehensive study design fitting all the requested information for an AI/ML medical device.

Based on the provided text, here's what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The text mentions "prototype Preceptive electric dental control units" but does not quantify how many unique units or test runs were involved.
• Data Provenance: Not specified, but implied to be internal testing at Lares Research ("in-house usability testing"). It is a nonclinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. The text mentions "usability testing" but does not detail the involvement or qualifications of experts or a formal ground truth establishment process in the context of device performance.

4. Adjudication method for the test set

• This information is not provided.

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

• This information is not applicable/provided. The device is an electric dental motor and control unit, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This information is not applicable/provided in the context of an AI/ML algorithm. The performance described relates to the electromechanical operation of the dental motor and control unit itself.

7. The type of ground truth used

• The ground truth for the performance tests appears to be direct measurement of the device's output (motor speed, direction, light output) against its intended operational parameters. It's not expert consensus, pathology, or outcomes data in the typical sense of AI/ML diagnostic devices.

8. The sample size for the training set

• This information is not applicable/provided as this is not an AI/ML device that requires a distinct training set for an algorithm. If "training set" refers to development testing, it is not specified.

9. How the ground truth for the training set was established

• This information is not applicable/provided.

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Products intended for professional use only. Used in general dentistry for restoration procedures.
Lares Research Smoothdrive 1:5 contra angle handpiece is intended for professional use only. The device is used in general dentistry for restoration procedures.

The Lares Research Smoothdrive 1:5 contra angle is a high-speed dental handpiece which is driven by an electrical motor. The device is designed to be connected to ISO 3964 compatible electric motors operating between 0 and 40,000 rpm. The device has a 1:5 speed increasing transmission (identified by the industry standard red ring) which translates to a working end speed of 0 to 200,000 rpm. The device has a push button chucking system is designed to allow convenient bur changing for ISO 1797 type 3 burs.

The requested information is not available in the provided text. The document is an FDA 510(k) clearance letter for a dental handpiece, focusing on substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness with AI.

The document states:

• "No clinical field trials have been conducted with the Lares Research Smoothdrive 1:5 contra angle handpiece." (Page 4)
• "Performance tests were conducted in-house at Lares Research with production samples of the Smoothdrive 1:5 contra angle. The contra angle motor connection, speed, sound, temperature and chucking mechanism were all evaluated during validation testing. Validation testing concluded the device meets all of the applicable consensus standards." (Page 4)

Without further details on the "applicable consensus standards" and the specific results of the validation testing, the acceptance criteria and detailed study information cannot be extracted.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the provided information.

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The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces is intended to be used by licensed dental professionals to reduce hard tooth structure, carry out cavity preparations and perform restorative dentistry.

The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces are the next generation of the Lares high-speed handpiece product line. The Lares Research 557 and 757 ProStyle model product family of highspeed handpieces are substantially similar to the 557 Turbo+ and 757 Workhorse as they are light weight, air-driven high-speed turbine dental drills connected to standard ISO 9168 Type 2 and Type 3 dental unit hose connections. The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces features include a solid glass fiber optic element and optional Kavo Multi-Flex compatible swivel quick connection.

This document describes the premarket notification (510(k)) for the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces. The document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a standalone study with a defined ground truth.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it relies on a comparison of technological characteristics and compliance with a general standard.

Study Proving Device Meets Acceptance Criteria:

The study presented is a nonclinical performance test to demonstrate compliance with the ISO 14457: 2012 standard for air-driven high-speed dental handpieces.

• Acceptance Criteria for this study: The device must pass "all the applicable tests of ISO 14457: 2012." The specific tests within ISO 14457:2012 are the de facto acceptance criteria. The document states that the device "passed all the applicable tests."

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

• Test Set Sample Size: "master device samples of the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces." This typically means a small number of physical units (e.g., 1-3 of each model) used for testing to the standard. It is not a statistically powered clinical trial sample size.
• Data Provenance: The tests were conducted on the manufactured samples of the new device. This is a prospective test specifically for this premarket notification. The document does not specify a country of origin for the testing, but the manufacturer is US-based (Chico, California).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• N/A. For this type of device (dental handpiece) and the nonclinical performance testing, the "ground truth" is adherence to the technical specifications and performance requirements outlined in the ISO 14457: 2012 standard. This is determined by engineering measurements and performance tests, not by expert consensus on, for example, image interpretation. There were no human experts involved in establishing a "ground truth" related to diagnostic accuracy.

4. Adjudication Method for the Test Set:

• N/A. There was no adjudication method in the sense of reconciling differences in expert opinions, as the assessment was based on objective physical measurements and adherence to technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study is not applicable to a high-speed dental handpiece. This type of study is used for diagnostic devices, particularly those involving human interpretation of data (e.g., radiologists reviewing images) to assess the impact of an AI tool on human performance.

6. Standalone Performance Study:

• Yes, implicitly. The nonclinical tests conducted in accordance with ISO 14457: 2012 represent a standalone performance evaluation of the device itself, without human-in-the-loop, against established engineering and safety standards for dental handpieces.

7. Type of Ground Truth Used:

• Engineering and Safety Standards / Technical Specifications: The ground truth for this device's performance evaluation against the ISO standard is derived from objective physical measurements and compliance with the defined limits and test methods specified in ISO 14457: 2012. For biocompatibility, the ground truth would be established by relevant ISO standards (e.g., ISO 10993 series), and for sterilization, by validated methods specific to sterilization.

8. Sample Size for the Training Set:

• N/A. This device does not involve machine learning or AI that requires a "training set."

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

• N/A. As there is no training set, this is not applicable.

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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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The SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The device is indicated for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact, fiber-optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, oral surgery. The following are the oropharangeal indications for use for which the device will be marketed:

• Excisional and incisional biopsies
• Excision and vaporization of herpes simplex I and II
• Exposure of unerupted teeth
• Fibroma removal
• Frenectomy and Frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscess
• Laser Assisted Uvulopaletoplasty (LAUP)
• This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring.
• Leukoplakia
• Operculectomy
• Oral Papillectomies
• Pulpotomy and Pulpotomy as an adjunct to root canal therapy
• Reduction of denture hyperplasia
• Reduction of gingival hypertrophy
• Reduction of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
• Removal of post-surgical granulations
• Selective ablation of enamel (First Degree Caries Removal)
• Soft tissue crown lengthening
• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
• Tissue retraction for impression
• Treatment of Apthous ulcers
• Vestibuloplasty

The laser device produces an invisible treatment beam for surgery and a visible aiming beam. The pulsed Nd:YAG treatment beam is an invisible beam of light (1064 nanometer wavelength); a Helium-Neon (HeNe) laser within the laser head console supplies the red aiming beam. The laser energy is developed inside an optical resonant cavity. A crystal rod of neodymium-doped Yttrium Aluminum Garnet (pulsed Nd:YAG) is placed between two mirrors. The rod is "pumped" by a flashlamp that excites the Neodymium ions in the YAG crystal. Once excited, stimulated emission of photons occurs. Laser energy exits the cavity through a partially transmitting mirror and enters the distal end of the contact fiber-optic cable at the aperture. The laser energy is transmitted though the fiber-optic cable and exits the proximal tip of the fiber. The device is controlled by microprocessor via keyboard access by the operator, which allows various settings for energy levels, pulse widths and repetition rates. Software controls preclude emission of laser energy in any of a number of fault conditions.

The provided text describes a medical device, the SunLase 800P Dental Laser (also marketed as PocketPro or PocketPro S4), and its intended uses. It is a 510(k) premarket notification and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria.

Therefore, many of the requested elements for describing an acceptance criteria study, such as sample sizes, expert qualifications, adjudication methods, and details about training/test sets, are not explicitly present in the provided document.

However, I can extract information related to the device description, its indications for use (which act as a form of acceptance criteria in regulatory submissions), and the rationale for its approval.

Here's a breakdown of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) submission are implicitly defined by the "Indications for Use" and the device's ability to perform these functions substantially equivalently to predicate devices. The "reported device performance" is essentially that it can perform these specified functions.

• Excisional and incisional biopsies
• Excision and vaporization of herpes simplex I and II
• Exposure of unerupted teeth
• Fibroma removal
• Frenectomy and Frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscess
• Laser Assisted Uvulopaletoplasty (LAUP) for cutting, ablating, coagulating and removing anatomically abnormal or naturally occurring hypertrophic oropharyngeal soft tissue associated with chronic palatal snoring.
• Leukoplakia
• Operculectomy
• Oral Papillectomies
• Pulpotomy and Pulpotomy as an adjunct to root canal therapy
• Reduction of denture hyperplasia
• Reduction of gingival hypertrophy
• Removal of filling material (gutta percha or resin) as adjunct treatment during root canal therapy
• Removal of post-surgical granulations
• Selective ablation of enamel (First Degree Caries Removal)
• Soft tissue crown lengthening
• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
• Tissue retraction for impression
• Treatment of Apthous ulcers
• Vestibuloplasty | The device is indicated for and effectively used in these procedures, with the rationale that its technology and tissue effects are substantially equivalent to legally marketed predicate devices for these applications. |
  | Safety: Software controls preclude emission of laser energy in a number of fault conditions. | Not explicitly quantified in terms of specific performance metrics, but presented as a design feature for safety. |

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. The document is a 510(k) notification, which primarily relies on substantial equivalence to predicate devices rather than a de novo clinical study with a detailed test set. The approval is based on the argument that the SunLase 800P is "based on the same technology" and that its operational technology differs "only by source of emission, pulse rate, and wavelength" from predicate devices. It states, "Tissue effects by predicate Nd. YAG and diode devices exhibit identical physical characteristics." This suggests a reliance on existing knowledge and effects of similar devices, rather than a specific test set of cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As there is no described test set or clinical study to establish ground truth in the traditional sense, information on experts is not part of this document. The "ground truth" for this application is essentially the established clinical utility and safety of the predicate devices.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or clinical study requiring adjudication is described.

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/Not provided. This is a hardware device (laser) and the submission does not involve AI or human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a physical laser device, not an algorithm. Its operation inherently involves a human operator.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices for the specified indications. The applicant argues that the SunLase 800P is substantially equivalent to these predicates due to similar technology, operational characteristics, and identical physical characteristics of tissue effects.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" as this is not a machine learning or AI device. The device's design and functionality are based on established laser technology.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no training set in the context of this device, this question is not relevant to the provided text.

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The SunLase 800P is indicated for incising, excising and coagulating intraoral soft tissue, including the marginal and interdental gingiya. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

Not Found

I apologize, but this document contains a letter from the FDA regarding a 510(k) clearance for the Sunlase 800P Laser System. It does not contain any information about acceptance criteria or a study proving device performance in the way you've outlined in your request (e.g., test sets, ground truth, expert qualifications, MRMC studies).

The document is a notification of substantial equivalence for a medical device, which means the device was found to be as safe and effective as a legally marketed predicate device. The 510(k) process typically doesn't involve the detailed performance study data you're asking for in this format, especially for devices cleared in 1999.

Therefore, I cannot fulfill your request with the provided input.

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