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The UltraLase Flexible CO2 Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surveology, podiatry, gyneology, and urology procedures. It is used to deliver laser energy for incision, ablation, vaportzation, and coagulation of soft tissues.

The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached

The UltraLase Flexible CO2 Laser Waveguides are laser delivery systems for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue.

The wavequide consists of a flexible silica capillary who's inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a protective sleeve.

The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6um and has a broad enough transmission band to accommodate any laser operating in this region.

The laser energy is coupled into the waveguide using the correct focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.

The laser waveguides have either a 905 SMA connector or a 953 ST connector attached and can therefore be used with any CO2 Laser that is compatible with one of these connectors. The wavequides are 2 meters long.

It is recommended that a purge gas be used to flow a gas through the wavequide to keep the inner channel of the wavequide free of debris.

The waveguides delivery systems are supplied sterile for single use.

The provided text describes a 510(k) premarket notification for a medical device called the "UltraLase Flexible CO2 Laser Waveguide." This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new studies. Therefore, many of the requested categories for a typical medical device study that proves predefined acceptance criteria are not applicable in this context.

However, I can extract the information that is present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The non-clinical tests performed are listed, along with their acceptance criteria. The document states that the new device met these criteria, implying its performance aligns with them.

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

The document does not specify the sample sizes for the non-clinical tests. It refers to these as generic "tests." The data provenance is not explicitly stated, but these are non-clinical tests, meaning they were likely conducted in a laboratory setting by the manufacturer, Laser Engineering, in the US (Milford, MA). The tests are retrospective, as they were conducted to support a premarket notification for a device modified from a previously cleared one.

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. For non-clinical tests like material biocompatibility or mechanical strength, "ground truth" would typically be defined by established international standards (e.g., ISO for ETO residual) or internal product specifications rather than expert consensus on a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving diagnostic interpretations by multiple human readers, not for non-clinical engineering or biological safety tests.

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 device is a passive surgical tool (a laser waveguide), not an AI-powered diagnostic or assistive tool. No MRMC study was performed, and no AI component is mentioned.

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

Not applicable. This device is a physical instrument, not an algorithm. Therefore, no standalone algorithm-only performance testing was done.

7. The type of ground truth used

For the non-clinical tests:

• Performance Testing (Power Transmission): The ground truth is the engineering specification of greater than 70% transmission after sterilization.
• Biocompatibility (Intracutaneous, Muscle Implant, Systemic Toxicity): The ground truth is established by specific biological endpoints (e.g., "no evidence of irritation," "microscopic reaction not significant," "no mortality or systemic toxicity") as defined by relevant biocompatibility standards (e.g., ISO 10993 series).
• Sterilization & Residuals (Sterilization Validation, ETO Residual, Bioburden): The ground truth is defined by specific quantitative targets or compliance with standards (e.g., "sterility assurance level of 10^-6", "Meets requirements of ISO 10993-7", "Less than 100").
• Mechanical (Epoxy Strength, Package Integrity): The ground truth is based on engineering specifications (e.g., "15 Newtons for 15 seconds") or visual/physical inspection criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this device.

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Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers.

The W&H Assistina TWIN MB-302 is an electrically and pneumatically driven maintenance device with the following functions:

• Rinsing the spray channels with cleaning solution (water basis) and drying with compressed air.
• Lubricating the rotational internal gear parts. The oil is spread and a constant lubrication film is set up.

The provided text describes the W&H Assistina TWIN MB-302, a device for cleaning and lubricating dental and surgical handpieces. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance against those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth), and training set information is not available in the provided text.

The closest information provided related to performance or testing is under the "Performance Testing" section (page 6), which lists various tests performed to demonstrate safety and effectiveness:

• Electrical Safety Tests according to IEC 61010-1
• Electromagnetic Compatibility Test according to IEC 61326-1
• Software validation according to IEC 62304:2006
• Biological Assessment and Cytotoxicity Testing of the liquids according to EN ISO 10993
• Risk Analysis according to ISO 14971
• Testing of cleaning performance according to ISO 15883
• Validation of wipe disinfection according to the IFU
• Bench Tests like Lifetime tests (Activation of start button, moving/removing of sliding door, Lifecycle test)

However, specific acceptance criteria values and the reported performance against these criteria are not detailed. The text only states that the results "demonstrate substantial equivalence" and that the biological assessment "meets the requirements," without specifying what those requirements are or the numerical results achieved. It also explicitly states "Clinical Testing: Not applicable," indicating that no clinical studies were performed.

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Pneumatic drive system for dental handpieces and dental air motors, which is intended to be used in general dental applications such as: removal of decayed materials, cavities and crown preparations, removal of filings, finishing of tooth and restauration surfaces, polishing, prophylaxis and endodontics.

The Advanced Air System is intended for dental transmission instruments used in the field of preventive dentistry, restorative dentistry such as cavity preparation and prosthodontics such as crown preparation and endodontics.
The system consists of the control unit (AC-1.0), which is designed to be built in a dental chair. As an attachment the air-driven handpiece (RK-97 L, RG- 97 L, and/or RK-94 L) or the air motor (RM-25 L RM) can be used.
The air-driven handpiece is equipped with a speed sensor, which is connected to a control module that regulates the applied air pressure to the handpiece through a proportional valve in order to maintain constant speed throughout the dental treatment.

This document describes a 510(k) premarket notification for the "Advanced Air System" device. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical acceptance criteria for new therapeutic or diagnostic claims. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, expert ground truth, and statistical performance metrics (like those used for AI/ML devices) is not directly applicable or available in this document.

However, I can extract information related to the device's technical specifications and the non-clinical performance testing conducted to support its substantial equivalence.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in the sense of clinical performance thresholds (e.g., sensitivity, specificity, or therapeutic efficacy rates). Instead, it establishes substantial equivalence based on a comparison of technological characteristics and adherence to recognized standards.

Technological Characteristics Comparison (Subject Device vs. Predicate Device)

The report concludes that the "differences between the devices shown in the side-by-side comparison table above are minor and do not have any negative effect on equivalence."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The performance testing described is primarily non-clinical, involving engineering and biocompatibility evaluations, not data from a test set of clinical cases.

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 device is a dental handpiece system, and its approval relies on technical specifications and non-clinical performance, not expert-adjudicated ground truth as would be required for a diagnostic or AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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, as this is not an AI/ML diagnostic or assistive device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's performance is adherence to recognized engineering standards and comparison to a legally marketed predicate device's technical specifications and performance.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" proving the device meets the "acceptance criteria" (defined here as demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards) consists of a series of non-clinical tests:

• Electrical Safety Tests: According to IEC 60601-1:2005.
• Electromagnetic Compatibility (EMC) Test: According to IEC 60601-1-1:2007.
• Product Testing of Handpiece Function and Life Cycle Testing: Per ISO 14457:2012 (Dentistry - Handpieces and Motors).
• Software Validation: According to IEC 62304:2006 (Medical device software).
• Usability Validation: According to IEC 62366:2007.
• Thermal Safety: According to IEC 62471:2006 (Photobiological safety of lamps and lamp systems).
• Biocompatibility Evaluation: Based on identical patient-contacting materials with previously cleared W&H handpieces (TA-97LED and AM-25L RM) and Cytotoxicity Testing per EN ISO 10993-5:2009-06. This evaluation meets ISO 7405:2008.

The document states, "The results demonstrate substantial equivalence in this regard" for the product testing. No clinical data was deemed necessary for this submission. The overall conclusion is that "The “Advanced Air System”, as designed and manufactured, is substantially equivalent to its predicate device."

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Piezomed is a piezoelectric ultrasonic device, consisting of handpieces and associated instruments, intended for:

• Bone Cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
• Scaling applications, including:
  • o Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
  • o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
  • o Endodontic: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha-condensation and retrograde preparation;
  • o Restorative and Prosthetics: Cavity preparation, removal of prostheses, finishing of crown preparations.

Piezomed SA-320 is an ultrasonic drive unit intended for the treatment of organic hard and soft tissue in dental surgery, implantology, maxillofacial surgery and periodontics.

The device consists of the control unit, the foot control, the piezo handpiece incl. cable, an irrigation tubing set, the instrument set "Bone" and the corresponding instrument changer, and various accessories such as the stand and a motor rest.

The unit provides an instrument (tip) detection, choosing automatically the power class fixed for the attached instrument (tip). Within certain limits the user can change the pre-adjusted power settings manually. Furthermore, the user can choose between three adjustable working modes (Power, Basic, Smooth). A boost function enables a short-term power increase by 20 %. A LED lighting ring provides illumination of the surgical site.

This document is a 510(k) submission summary for a medical device and thus does not include the detailed study protocols, criteria, or results that would be found in a clinical trial report. The information provided is primarily to demonstrate substantial equivalence to a predicate device, not to prove defined acceptance criteria through a specific study in the way typically found for an AI/ML device.

However, based on the provided text, I can extract information related to performance testing that served to demonstrate the device met regulatory requirements for substantial equivalence.

Here's an interpretation based on the provided document:

Acceptance Criteria and Reported Device Performance

The document describes the Piezomed SA-320 as a revised and improved version of a predicate device (Piezosurgery Touch, K122322). The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device by meeting relevant performance standards.

Study Details:

1. Sample size used for the test set and the data provenance:

   • This document does not specify a "test set" in the context of data for an AI/ML algorithm. The performance testing described refers to physical device testing according to established standards. For these tests, the sample size would typically refer to the number of devices or components tested. This information is not provided in the summary.
   • Data Provenance: Not applicable, as this is related to physical device testing, not data-driven algorithm validation.

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

   • Not applicable as this is a traditional medical device (piezoelectric ultrasonic device), not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests are the objective measurements from the standards and physical properties.

3. Adjudication method for the test set:

   • Not applicable for the same reasons as above. Testing involved adherence to published international standards for medical devices.

4. 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, an MRMC comparative effectiveness study was not done. This device is not an AI/ML enabled device designed to assist human readers or clinicians in interpreting images or data. It is a surgical tool.

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

   • Not applicable. This device is a physical, human-operated medical tool, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance testing cited is adherence to objective criteria and methodologies outlined in recognized international standards (e.g., IEC 60601-1, ISO 22374). This is physical and electrical property testing against defined limits, not expert judgment on medical data.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no training set.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as above.

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The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.

The UltraLase Flexible CO2Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The UltraLase Flexible CO2 Laser Waveguide is a laser delivery system for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue. The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a plastic sleeve for protection. The UltraLase Flexible CO2 Laser Waveguide is supplied with a single use handpiece attached or without a handpiece so it can be used with various reusable handpieces such as the TTI Medical ACCU-Beam Fiberoptic Handpieces.

The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6µm and has a broad enough transmission band to accommodate any laser operating in this region.

The laser energy is coupled into the waveguide using the supplied focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.

The UltraLase Flexible CO2 Laser Waveguides come with either a 905 SMA connector or a 953 ST connector and are therefore can be used with any CO2 Laser that is compatible with one of these connectors. The waveguide is supplied in several diameters and lengths as shown in the following chart.

It is recommended that a purge gas system using an inert gas such as helium be used to force an inert gas through the waveguide for cooling and to keep the inner channel of the waveguide free of debris.

The waveguides delivery systems are supplied sterile for single use.

Here's an analysis of the provided text regarding the UltraLase Flexible CO2 Laser Waveguide's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It largely describes the device's technical specifications and intended uses, and then states that it was "bench tested" for transmission bandwidth and percent transmission. It does not present specific numerical acceptance criteria or detailed results from these bench tests beyond confirming they were performed. The "reported device performance" in the table above is thus an inference that the device met internal criteria for its design specifications, rather than a direct report of specific performance values against pre-defined numerical objective criteria.

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

The document does not explicitly state a sample size for a dedicated "test set" in the context of clinical trials or specific performance verification. The performance testing mentioned ("bench tested to establish transmission bandwidth, and percent transmission") refers to laboratory/engineering testing rather than a clinical study with a distinct patient test set.

• Test Set Sample Size: Not specified for clinical or comparative studies. For bench testing, the sample size of waveguides tested is not mentioned.
• Data Provenance: The bench testing is implied to be internal to Laser Engineering (the applicant). There is no mention of country of origin for any data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for this type of device, extensive clinical data from human subjects is often not required if substantial equivalence can be demonstrated through technological characteristics and engineering testing.

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

This information is not applicable or not provided in the document. The submission is a 510(k) for a CO2 laser waveguide, which is a device for energy delivery. The performance testing described is engineering-focused (transmission bandwidth, percent transmission). There is no mention of a "test set" that would require expert-established ground truth in a diagnostic or interpretive context.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. As there's no mention of a clinical "test set" requiring expert interpretation or diagnosis, no adjudication method would be in play.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. The submission focuses on demonstrating substantial equivalence through technological characteristics and bench testing, not on comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. The UltraLase Flexible CO2 Laser Waveguide is a physical medical device (a fiber optic waveguide) used to deliver laser energy, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the described "bench testing to establish transmission bandwidth, and percent transmission," the "ground truth" would be established by physical measurements and engineering standards/specifications for laser light transmission through a fiber optic waveguide. It is not expert consensus, pathology, or outcomes data, as those are relevant for diagnostic or treatment efficacy studies.

8. The Sample Size for the Training Set

This information is not applicable or not provided. As the device is not an AI/ML algorithm or a diagnostic tool that learns from data, there is no "training set."

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

This information is not applicable or not provided. As there is no "training set," there is no ground truth establishment for one.

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The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1

The cordless Prosthodontic Screwdriver IA-400 consists of the cordless drive IA-40H, the contra-angle attachment IA-80 and a key pad (finger switch). The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964. By means of the different buttons on the drive the user controls the various settings, such as ON, forward/reverse and the torque. The attached key pad (finger switch) allows starting and stopping the screwdriver's rotation. The handpiece's application is intended in dentistry.

The provided 510(k) summary for the "Prosthodontic Screwdriver IA-400" does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical or performance study for an AI/CADe device would.

This submission is for a physical medical device (a dental handpiece), not a software-based or AI-powered diagnostic device. Therefore, the questions related to AI/CADe studies, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this 510(k) document.

The "Performance Testing" section states: "W&H's Prosthodontic Screwdriver IA-400 was developed and is produced under consideration of all applicable technical standards and quality management directives. The product's conformance with the applicable technical standards was verified in the course of type testing. Bench testing results demonstrated substantially equivalence. Perfect functionality and accuracy of all serial devices are controlled in the final step of production."

This implies that performance was assessed against relevant technical standards and internal quality controls through bench testing. The acceptance criteria would likely be derived from these technical standards for dental handpieces, focusing on aspects like torque accuracy, power output, durability, and safety, as well as demonstrating substantial equivalence to predicate devices.

Here's a breakdown based on the provided document, acknowledging the non-AI nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the performance testing at a high level. Specific, quantifiable acceptance criteria and detailed reported performance values are not provided in this 510(k) summary. Instead, it broadly states:

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

• Test Set Sample Size: Not explicitly stated. For bench testing of a physical device like this, the 'sample' would refer to the units tested during type testing and then controls during production.
• Data Provenance: Not specified, but implied to be from W&H Dentalwerk Buermoos GmbH's internal testing facilities in Austria ("A - 5111 Buermoos Austria").
• Retrospective/Prospective: Not applicable in the context of clinical studies for this device.Bench testing is generally part of a prospective product development and verification process.

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

• Not applicable as this is a physical device undergoing bench testing against technical standards, not a diagnostic device requiring expert interpretation of results for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. The assessment would involve direct measurement and comparison against technical specifications.

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/CADe device.

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

• Not applicable. This is not an AI/CADe device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For bench testing of a physical medical device, the "ground truth" or reference standard would be the engineering specifications, established technical standards (e.g., ISO standards relevant to dental handpieces), and performance characteristics of the predicate device. Measurements taken during testing would be compared against these predefined standards.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device that requires a training set.

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

• Not applicable. This is not a machine learning/AI device that requires a training set.

In summary: The 510(k) for the Prosthodontic Screwdriver IA-400 relies on bench testing against applicable technical standards and comparison to predicate devices to demonstrate substantial equivalence, rather than clinical trials or AI performance studies.

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Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.

RA-5 "ANESTO" is a handpiece, which, on the one hand, is provided with a coupling system according to ISO 3964. This coupling allows the handpiece's attachment onto a corresponding dental motor, for transmitting the motor's rotational movement to the attached intraosseous injection needle, intended to perforate cortical bone. On the other hand, it was designed for being equipped with an anesthetic cartridge acc. ISO 11499, volume 1.7 or 1.8ml. After having perforated the bone, this cartridge's anesthesia can be administered locally in the spongiosa by means of a manually-operated dosage lever. "ANESTO's" application is intended in dentistry.

The provided text describes the 510(k) summary for the "Handpiece RA-5 'ANESTO'" and its substantial equivalence determination. However, it explicitly states:

• "Clinical data were not needed for this new product."
• "Bench testing results demonstrate substantially equivalence."

This means that a formal clinical study with acceptance criteria, human readers, ground truth establishment, and training/test sets as typically understood for an AI/ML device was not conducted for this specific medical device submission. The substantial equivalence was based on bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, ground truth types, or training set details because this information is not present in the provided document.

Instead, the submission relies on the device being "substantially equivalent" to predicate devices based on:

• Intended Use: Drilling system to perforate cortical bone to administer local anesthesia in spongiosa; application in dentistry.
• Technological Characteristics: Similar to the predicate, but designed to be attached to and driven by a dental micro motor (air or electric motor) instead of an integrated air-supplied driving system. Handpiece shape and ease of operation were improved.
• Performance Parameter: Stated as "very similar to the predicate device."
• Material: Stated as "very similar to the predicate device."
• Performance Testing: Bench testing results were used to demonstrate substantial equivalence.

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Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument (>>ENDO file <<), which is intended by the manufacturer for use in the mechanical and rotary preparation of the root canal.

The cordless ENDO-handpiece EB-300 (EB-300 S) consists of the cordless drive EB-3 H (EB-3 SH) and the special contra-angle attachment EB-16 (EB-16 S), intended for mechanical rotating root canal preparation. The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. By means of the different buttons on this drive, the user controls the various functions, such as on / off, speed, torque and auto-reverse / auto-forward mode. The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964. The handpiece's application is intended in dentistry.

The provided 510(k) summary for the W&H Cordless ENDO-Handpieces "ENTRAN" and "S5 ENDO Motor" states that clinical data were not needed and that bench testing results demonstrate substantial equivalence. This indicates that the device's acceptance criteria were based on functional performance and comparison to a predicate device, rather than patient-level outcomes.

Here's a breakdown based on your requested information, with specific notes where information is explicitly not provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specified. The document only mentions "Bench testing results."
• Data provenance: Not specified. As it's bench testing, it would be laboratory-generated data rather than patient data from a specific country.
• Retrospective or prospective: Not applicable for bench testing.

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

• Number of experts: Not applicable. Ground truth for most bench tests relies on engineering specifications, physical measurements, and adherence to standards rather than expert clinical consensus.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Bench tests typically involve direct measurement against specifications or comparison to a predicate device's performance under controlled conditions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC study: No, an MRMC study was not done. The document explicitly states: "Clinical data were not needed for these new products." This type of study would involve human readers and clinical cases.

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

• Standalone study: Yes, implicitly. The "Bench testing results" without clinical data indicate that the device's technical performance was evaluated independently, without requiring human-in-the-loop performance evaluation in a clinical setting for regulatory purposes. The device itself is an "algorithm" only in the sense of its mechanical and electrical function, not in the AI/software sense often associated with "standalone" studies in medical imaging.

7. The type of ground truth used

• Type of ground truth: The ground truth for this type of device (dental handpiece) would be based on engineering specifications, performance metrics (e.g., speed, torque, battery life, mechanical integrity), and direct comparison against the predicate device's documented performance. There's no indication of pathology, expert consensus, or outcomes data being used as ground truth for this 510(k).

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is a mechanical/electrical handpiece, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Any development data used by the manufacturer would be internal design and testing data.

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

• How ground truth was established for training set: Not applicable, as there is no "training set" for this type of device. The ground truth for design and development would be established through engineering principles, material science, and performance targets set by W&H Dentalwerk Buermoos GmbH.

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The dental contra-angle handpiece "KOMET - OS30" is intended for mechanical interproximal enamel reduction (stripping, slenderizing) in use of an oscillating movement

The dental handpiece attachment "KOMET - OS30" is a drive, in order to enable the mechanical interproximal enamel reduction by means of the oscillating movement of the attached "KOMET - OS Discs". "OS30" is provided with a coupling system according to ISO 3964, allowing the handpiece's attachment onto a corresponding dental motor. The handpiece's gearing elements transmit the motor's rotational movement up to the integrated head gear, where this movement is converted into an oscillating one. The "OS Disc", chucked in the said head gear, oscillates in an angle of 30°, depending on the motor's speed with max. 5.000 oscillations/min.

The provided document is a 510(k) Pre-market Notification for a dental contra-angle handpiece. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a formal study with detailed performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, a specific study proving device performance, sample sizes, expert involvement, adjudication methods, or MRMC/standalone studies as typically found for AI/imaging device submissions.

Here's why and what information can be extracted:

• Acceptance Criteria & Reported Device Performance: This document states "Bench testing results demonstrate substantially equivalence," but does not provide a table of specific acceptance criteria or quantitative performance data. The device is a mechanical contra-angle handpiece, not an AI or diagnostic imaging device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its acceptance is based on demonstrating it functions similarly to existing, cleared devices.

• Sample Size (Test Set) and Data Provenance: Not applicable. Performance testing for this device would likely involve mechanical and functional benchmarks, not a "test set" of patient data.

• Number of Experts and Qualifications: Not applicable. Ground truth for this type of mechanical device is typically established through engineering specifications and functional testing, not expert clinical interpretation.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a mechanical device, not an AI diagnostic tool where human reader performance would be a factor.

• Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.

• Type of Ground Truth: For a dental handpiece, the "ground truth" would be engineering specifications and successful functional operation (e.g., maintaining oscillations, durability, safety parameters). The document implies that this was established through "bench testing results."

• Sample Size for Training Set: Not applicable. This is a manufactured product, not a machine learning model.

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of available information related to performance/equivalence:

1. Acceptance Criteria/Reported Device Performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate devices (Dentsply International: "Interproximal Reduction System", K053368, and A-dec Incorporated: "A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachment WA-67...", K082827). This implies meeting similar safety and performance envelopes as the predicates.
   • Reported Device Performance: "Bench testing results demonstrate substantially equivalence." The device is described to convert rotational movement into an oscillating movement, with the "OS Disc" oscillating in an angle of 30°, depending on the motor's speed, with max. 5,000 oscillations/min. This performance is consistent with its intended mechanical function and similar to predicate devices.

2. Sample Size (Test Set) and Data Provenance: Not provided/Not applicable given the device type.

3. Number of Experts and Qualifications: Not provided/Not applicable.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No.

6. Standalone Performance Study: No, as it's a mechanical device. Performance was assessed via "bench testing results."

7. Type of Ground Truth: The ground truth for proving substantial equivalence was based on engineering specifications and functional performance verified through "bench testing."

8. Sample Size for Training Set: Not applicable.

9. How Ground Truth for Training Set Was Established: Not applicable.

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Surgical treatment of dental hard tissue in oral and maxillo-facial surgery

Surgical handpieces and Mikro saw handpieces have been designed to transmit the rotational movement of the motor axle to the shank of a bur or a saw blade which will be inserted into the output end of the handpiece. They fit all surgical drive units and surgical motors with a coupling system according to ISO 3964. The user manual points out the recommendations for the different handpiece types covered by this application.

Here's an analysis of the provided text regarding the acceptance criteria and study for the W&H Dentalwerk Buermoos GmbH surgical handpieces:

It's important to note that the provided document is a 510(k) summary for a dental surgical handpiece, which is a mechanical device. The information requested in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set, etc.) is primarily relevant for AI/ML-based medical devices or diagnostic tools that involve interpreting data or images.

For a mechanical device like a surgical handpiece, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on bench testing to ensure mechanical, electrical, and material performance, as well as safety and effectiveness compared to a predicate device. There is no AI/ML component to this device.

Therefore, many of the requested fields cannot be directly answered from the provided text, as they are not applicable to the type of device being described.

Here's a breakdown of what can be extracted and what cannot:

Device: Surgical straight handpiece SI-11 LED G, Surgical contra-angle handpiece WI-75 LED, Mikro saw handpieces S-8 R, S-8 O, S-8 S

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. For a mechanical device, "sample size" and "data provenance" in the context of a "test set" (as typically understood for AI/ML) are not relevant. Performance was assessed via bench testing, which involves physical testing of the device prototypes/samples. The specific number of physical units tested is not provided, nor is the "country of origin of data" in this context.

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 device does not involve a "ground truth" established by experts in the diagnostic sense. The performance evaluation is based on engineering principles and physical measurements from bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No expert adjudication method was employed as there is no diagnostic output requiring such a process.

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 a mechanical surgical tool, not an AI-assisted diagnostic device. No MRMC study was performed.

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

• Not Applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Engineering Standards & Predicate Comparison. The "ground truth" for this type of device is adherence to engineering specifications, performance parameters validated through bench testing, and demonstrating substantial equivalence to the legally marketed predicate device(s).

8. The sample size for the training set

• Not Applicable. This device does not have a "training set" as it does not involve machine learning.

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

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

In summary, the provided document details the 510(k) clearance for a mechanical dental surgical handpiece. The "acceptance criteria" and "study" described are typical for such devices, primarily relying on bench testing to demonstrate performance and substantial equivalence to existing predicate devices, particularly regarding mechanical function, material compatibility, and safety. The questions posed in the prompt are almost entirely tailored to AI/ML-based diagnostic devices and, therefore, do not align with the nature of this product.

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