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The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:

• Removing supra and subgingival calculus deposits and stains from teeth .
• Periodontal pocket lavage with simultaneous ultrasonic tip movement .
• Scaling and root planing .
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta ● percha
• Plugging for amalgam condensation .
• Amalgam burnishing ●
• Preparing, cleaning and irrigating root canals .
• Cavity preparation .
• . Cementing inlays and onlays
• Retrograde preparation of root canals ●

The proposed Piezon® Master 600 is a modification of the Piezon® Master 400. The modified Piezon® Master 600 consists of the main scaler unit (including a peristaltic pump for irrigant delivery), hoses and connectors for two handpieces, a foot control containing a four-position switch, and two bottles for holding irrigation liquids. The Piezon® Master 600 is supplied with one of a number of optional Instrument Systems (containing a Universal handpiece and scaling instruments), a flat key, and a torque tool (CombiTorque) for attaching instruments to the handpiece.

This document is a 510(k) summary for a medical device (EMS Piezon® Master 600) and does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving device performance. This type of submission is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a full clinical trial report with detailed performance metrics.

However, I can extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria (e.g., maximum leakage current, specific EMC levels).
• Detailed quantitative performance data (e.g., cleaning efficiency, scaling precision, time to complete tasks for new applications, vibration characteristics, efficacy rates for specific procedures). The document mentions "enhanced ultrasonic performance" but doesn't provide metrics.

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

This document does not provide a sample size for a test set in the context of clinical or performance data. The "performance testing" referred to (electrical safety, EMC, design control) are engineering and regulatory compliance tests, not typically clinical studies involving patient data.

Missing Information:

• Sample size for any test set involving performance on human or animal subjects.
• Data provenance (country of origin, retrospective/prospective).

3. Number of Experts and their Qualifications for Ground Truth

This document does not describe the establishment of a ground truth by experts in the way you've outlined for clinical studies. The performance testing mentioned refers to engineering and design verification.

Missing Information:

• Number and qualifications of experts for ground truth.

4. Adjudication Method for the Test Set

This document does not describe any adjudication method for a clinical test set, as no such test set is detailed.

Missing Information:

• Adjudication method.

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

This document does not mention or describe a MRMC comparative effectiveness study. The device is an ultrasonic scaler, suggesting a focus on mechanical performance rather than image interpretation by human readers.

Missing Information:

• Information on MRMC study or AI-assisted improvement for human readers.

6. Standalone (Algorithm Only) Performance Study

The device is a physical ultrasonic scaler, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable in this context.

7. Type of Ground Truth Used

For the engineering and design verification tests mentioned, the "ground truth" would be established by engineering standards, regulatory requirements, and internal design specifications. For example, electrical safety is judged against a standard like IEC 60601-1, and EMC against relevant IEC or national standards. These are not "expert consensus, pathology, or outcomes data" in the typical clinical sense.

8. Sample Size for the Training Set

This document does not refer to a training set as would be used for an AI/machine learning algorithm. The development of this physical medical device would involve design, prototyping, and iterative testing, but not a "training set" in that context.

Missing Information:

• Sample size for a training set.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, this information is not applicable.

Summary of what the document does provide regarding performance and acceptance:

The document describes the device as a modification of a predicate device (Piezon® Master 400). The modifications aimed to enhance procedural flexibility and ease of use, and included "enhanced ultrasonic performance." The basis for substantial equivalence is that these modifications do not alter the general intended use or fundamental scientific technology. New applications (cavity preparation, cementation, retrograde root canal preparation) are covered by equivalence to another predicate device (EMS KERMIT®) which was previously cleared for those uses.

Performance testing was conducted as part of design verification and validation activities. These included:

• Electrical safety testing
• Electromagnetic compatibility testing (EMC)
• Completion of Design Control Checklists to ensure all design requirements were fulfilled.

The results of these engineering/regulatory compliance tests "confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures." The FDA's substantial equivalence determination implies these tests met the necessary acceptance criteria for the device to be marketed.

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The EMS AIR-FLOW® handy 2 is intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching. fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

The AIR-FLOW® handy 2 is a modified version of the AirFlow® handy previously cleared under K991857. As with the original AirFlow® handy device, the proposed AIR-FLOW® handy 2 is a turbine-adaptable air polisher that consists of a hand-held device containing air and water lines, powder chamber with cap, and an AIR-FLOW® nozzle called the AIR-FLOW® handpiece.

Both the original and the modified device function by connecting to a standard turbine connection of the dental unit, which supplies air and water. The AIR-FLOW® handy 2 is activated when the AIR-FLOW® handy 2 Handpiece is fixed to the turbine connection and the dental unit pedal is pressed. Air enters the proximal end of the device and into the powder chamber where it is mixed with the AIR-FLOW® handy 2 powder. The air/powder mixture leaves the powder chamber and exits the distal end of the device through the AIR-FLOW® handpiece orifice where the air/powder mixture is enveloped by a water spray and directed onto the tooth surface.

The provided document is a 510(k) summary for a medical device (EMS AIR-FLOW® handy 2 Dental Handpiece). It details the device's intended use, description, and basis for substantial equivalence to a predicate device. However, it does not contain the detailed study information typically required to describe acceptance criteria and the methods used to prove the device meets them in the way modern AI/ML device submissions would.

Specifically, the document states:

"Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met. The final project monitoring results documented that all verification and validation activities required by the risk analysis were performed and all requirements of the design specifications were met."

This is a general statement about fulfilling design requirements and risk analysis, but it does not include:

• Specific acceptance criteria: What quantitative or qualitative metrics were used to determine "design requirements were met"?
• Reported device performance: What were the actual outcomes against those criteria?
• Details about the study: No information on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating where information is NOT available:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the EMS AIR-FLOW® handy 2 Dental Handpiece states that "Verification and validation of the device design requirements were performed to provide confirmation that all design requirements were met." However, it does not detail specific acceptance criteria or the reported performance data against those criteria in a tabular format as would typically be presented for performance studies. The submission focuses on demonstrating substantial equivalence to a predicate device (AirFlow® handy, K991857) through design modifications and function rather than an efficacy study with defined endpoints.

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 document states "Verification and validation of the device design requirements were performed," but provides no details on any test subjects, cases, or the number of items tested.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective)

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

• Not applicable/Not specified. The document does not describe a clinical study that would require expert-established ground truth. The "testing" referred to appears to be engineering design verification and validation.

4. Adjudication method for the test set

• Not applicable/Not specified.

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. This device is a dental handpiece, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is not applicable.

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

• Not applicable. This device is a physical dental tool, not an algorithm.

7. The type of ground truth used

• Not applicable. For a physical device like this, "ground truth" would typically refer to engineering specifications and performance against those specifications (e.g., air pressure, water flow, powder delivery rate, material strength, safety standards). The document generally states "all design requirements were met" but doesn't elaborate on the specific "ground truth" used or how it was established for performance aspects.

8. The sample size for the training set

• Not applicable. This device is a dental handpiece, not an AI/ML model that requires a training set.

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

• Not applicable.

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The EMS Swiss LithoClast® Master is intended for the intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder.

The EMS Swiss LithoClast® Master is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

The Swiss LithoClast® Master is a modified version of the Swiss LithoClast® previously cleared under K951531 and K963285. Three possible modes of operation are available using the Swiss LithoClast® Master: (1) pneumatic lithotripsy alone; (2) ultrasound lithotripsy alone; (3) and combined pneumatic and ultrasound lithotripsy. The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch. The pneumatic unit of the system is essentially the same as the Swiss LithoClast® Operation of this unit requires a supply of medical quality compressed air from either a compressor or a central hospital supply. The compressed air provides the pressure a compresses ve a be projectile within the Swiss LithoClast® handpiece toward the proximal end of the probe. The pressure pulse propagates to the distal tip of the probe and is transferred to the stone, resulting in fragmentation. The pneumatic unit prood and in combination with the Swiss LithoVac® for suction of stone fragments. The LithoClast® probes can be inserted through the LithoVac® probes for simultaneous lithotripsy and suction. The ultrasound handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating at approximately 24 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and probes are hollow, permitting simultaneous suction. Two probe sizes are available: 3.3 mm and 3.8 mm. Combined operation of the pneumatic and ultrasound units is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasound handpieces must be mounted together to form a LithoClast® Master handpiece using an adjustment interface. The 1 mm pneumatic probe is inserted through the adjustment interface and through either the 3.3 mm or 3.8 mm ultrasound probe. The probes must be length-adjusted by turning the nut of the adjustment interface so that the tip of the pneumatic probe is flush with the tip of the ultrasound probe.

The provided text describes a 510(k) submission for the Electro Medical Systems SA SWISS LITHOCLAST® MASTER. It is a premarket notification to establish substantial equivalence to a legally marketed predicate device, not a study designed to prove the device meets specific performance acceptance criteria in the way a clinical trial or a novel AI device study would.

Therefore, many of the requested categories are not directly applicable or explicitly detailed in this type of regulatory document. The focus of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to set new performance benchmarks with explicit acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred:

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

This document does not specify formal, quantitative acceptance criteria for device performance as would be found in a study for a novel device. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The performance reported is in relation to this goal.

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 mentions "stone fragmentation testing" on "a variety of standard artificial stone materials."

• Sample Size for Test Set: Not explicitly stated. It refers to "a variety of standard artificial stone materials," implying multiple types of stones were tested, but the number of tests or specific sample sizes are not provided.
• Data Provenance: Not explicitly stated. The testing was likely conducted by the manufacturer, Electro Medical Systems SA, located in Nyon, Switzerland. This would imply an in vitro laboratory test rather than a clinical study with patient data. As such, it's not "retrospective or prospective" in the clinical sense.

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

Not applicable. The "stone fragmentation testing" likely involves objective physical measurements (e.g., time to fragmentation, fragment size analysis) in a laboratory setting, not expert clinical assessment of "ground truth."

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

Not applicable. This concept applies to human expert review of clinical cases. The stone fragmentation testing would involve laboratory protocols and measurement.

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 device or a diagnostic imaging device that would typically involve human readers.

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

Not applicable. This is a medical device for intervention (lithotripsy), not an algorithm or AI. The performance discussed is the device's physical ability to fragment stones.

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

The "ground truth" for the stone fragmentation testing would be defined by objective physical measurements of stone fragmentation parameters (e.g., time to fragment, fragment morphology, completeness of fragmentation) against a "standard" or established performance benchmark for predicate devices. It is based on in vitro laboratory measurements rather than expert clinical judgment or pathology.

8. The sample size for the training set

Not applicable. This is not an AI device. The device's design and operation are based on established pneumatic and ultrasonic lithotripsy principles, refined from previous versions.

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

Not applicable. As this is not an AI/ML device, there isn't a "training set" in that context. The "ground truth" for its development would be based on engineering principles, clinical experience with previous generations of the device (Swiss LithoClast®), and a scientific understanding of lithotripsy mechanisms, rather than a data-driven training set.

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The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.

The Multipurpose Probe is a rigid, 3 Fr (1.0 mm) Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece of the target to the stone. A lateral notch in the distal end of the probe allows for fixation of mobile ureteral stones, thus reducing the risk of stone push back in the ureter. The probe can be reused five times and may be sterilized by steam sterilization according to standard hospital procedures.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. This document is a 510(k) summary for a medical device (Swiss LITHOCLAST® Multipurpose Probe), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific statistical metrics.

However, based on the available information, I can extract and infer the following:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely inferred based on what would typically be evaluated for substantial equivalence in medical device submissions, as specific quantitative criteria are not explicitly stated in this summary.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified. The document mentions "clinical use assessment" but does not provide details on the number of patients or cases included in this assessment.
• Data Provenance: Not specified. It's likely that the testing (longevity, velocity, displacement, clinical use assessment) was conducted by the manufacturer (ELECTRO MEDICAL SYSTEMS SA) in Switzerland, but this is not explicitly stated. It is presented as an assessment to support substantial equivalence, not a formal clinical trial with geographic details. The type of data (retrospective or prospective) is also not stated.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the given text. The "clinical use assessment" and "basis for substantial equivalence" do not specify the involvement of experts in establishing a ground truth for a test set in the way a typical clinical study would. The summary focuses on comparing the new device to a predicate device through technical and basic clinical assessments, not on establishing a "ground truth" via expert consensus for a diagnostic task.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. There is no mention of a formal adjudication process for a test set, as this is not a study involving expert readers interpreting results against a consensus ground truth.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided summary. The submission focuses on demonstrating substantial equivalence through technical testing and a general "clinical use assessment," not a comparative study of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a mechanical lithotripter probe, not an algorithm or AI-powered system, so a standalone algorithm performance study would not be relevant.

7. Type of Ground Truth Used

• The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data, expert consensus on images) is not directly applicable to this device submission.
• Instead, the "truth" for this submission revolves around the performance characteristics of the probe (longevity, tip velocity, displacement) and its ability to fragment stones in a clinical setting, as compared to a predicate device.
• The "clinical use assessment" would have likely relied on clinical observations/outcomes (e.g., successful stone fragmentation, absence of complications) rather than a defined ground truth like pathology reports.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical instrument, not an AI or algorithmic system trained on data, so there is no training set in the conventional sense.

9. How Ground Truth for Training Set was Established

• Not applicable. As a physical medical device, there is no training set or ground truth in the context of machine learning.

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The EMS SwISS LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.

Not Found

Here's an analysis of the provided text regarding the acceptance criteria and study for the EMS SWISS LITHOCLAST LITHOTRIPTER, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K963285 does not explicitly state numerical acceptance criteria (e.g., minimum success rate, stone-free rate, or complication rate thresholds). Instead, the reported device performance is framed in terms of substantial equivalence to predicate devices. This means the acceptance criteria are implicitly tied to the safety and effectiveness profiles of the cited predicate devices as reported in medical literature.

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

• Sample Size: 83 kidneys
• Data Provenance:
  • Country of Origin: Not explicitly stated. The sponsor is Swiss (Electro Medical Systems SA, Switzerland), and the clinical study was conducted at "two investigational sites," but their locations are not provided.
  • Retrospective/Prospective: Retrospective clinical study.

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

This information is not provided in the given text. The study is described as a "clinical study of the results," suggesting that the outcomes were assessed by the clinicians at the investigational sites, but no details on their number or specific qualifications for establishing ground truth are given.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

There is no indication of an MRMC study. This device is a medical instrument (lithotripter), not an AI-powered diagnostic or interpretive tool that would typically involve "human readers" or "AI assistance" in the way an MRMC study evaluates.

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

This refers to a standalone clinical study of the device's performance without the explicit comparison to human interpretation or AI.

• Yes, a standalone clinical study was done. The "retrospective clinical study of the results on 83 kidneys" represents the standalone performance evaluation of the EMS SWISS LITHOCLAST.

7. The Type of Ground Truth Used

The ground truth implicitly relates to the clinical outcomes of stone fragmentation and clearance, as assessed by the clinicians treating the patients. This would fall under outcomes data or clinical assessment of treatment success and safety. The text uses terms like "results," "safety," and "effectiveness," which are direct clinical outcome measures.

8. The Sample Size for the Training Set

This information is not applicable / not provided. This is a medical device, not an AI/machine learning model that typically requires a distinct "training set" in the computational sense. The "clinical study" evaluates the device's performance, not the training of an algorithm.

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

This information is not applicable / not provided for the same reason as point 8. The concept of a "training set" and its "ground truth establishment" is not relevant to the evaluation of this type of medical device in the context described.

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The Electro Medical Systems SA LITHOVAC Suction/Aspiration Probe is designed for the suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes. It can be used alone, or it can be used during and after fragmentation of urinary tract calculi with the EMS Swiss LITHOCLAST intracorporeal lithotripter. It is specifically designed so that an EMS LITHOCLAST lithotripsy probe can be inserted through the LITHOVAC suction tube so that stone fragments and debris can be aspirated through the LITHOVAC suction tube simultaneously with lithotripsy.

The EMS SA LITHOVAC Suction/Aspiration Probe is intended to be used to aspirate out urinary calculi. fragments and debris using a standard vacuum source, i.e. a regulated wall vacuum, a standard suction pump, or a peristaltic pump which can supply up to -0.8 bar vacuum. Accessory adapters are provided to permit it to be used to aspirate urinary stone fragments or debris produce during fragmentation of urinary stones with the EMS Swiss LITHOCLAST lithotripter.

The LITHOVAC consists of a suction tube with a trumpet valve, and accessories for connecting the EMS Swiss LITHOCLAST handpiece and probe to the suction tube.

The LITHOVAC suction tube is made of type 304 stainless steel and is available in four diameter/length combinations as follows:

• 1.6 mm OD/445 mm length disposable sterile .
• 1.6 mm OD/555 mm length disposable sterile .
• 3.5 mm OD/460 mm length reusable non-sterile .
• 4 mm OD/430 mm length reusable non-sterile ●

The size of the suction tube is chosen according to the size of the endoscope to be used, e.g., the 4 mm LITHOVAC Probe is used through a 12 Fr or greater endoscope.

The provided text does not contain information on acceptance criteria for device performance or a study demonstrating the device meets those criteria. The submission is a 510(k) summary for the EMS LITHOVAC Suction/Aspiration Probe, primarily focusing on establishing substantial equivalence to predicate devices and describing the device's intended use and technological characteristics.

The "Performance Testing" section describes animal studies in a pig model to assess effectiveness and potential injury, but it does not specify acceptance criteria (e.g., success rates, aspiration volume, fragmentation efficiency targets) or detailed results against such criteria. The study mainly reports observations of mild ecchymosis and complete regeneration of urothelium, indicating safety rather than quantifiable performance against specific metrics.

Therefore, I cannot populate the table or answer the subsequent questions as the requested information is absent from the provided text.

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