Search Results
Found 11 results
510(k) Data Aggregation
(504 days)
NOUVAG AG
The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gyrocological procedures to morcellate and remove tissue.
The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.
The Morce Power Plus / VarioCarve is the drive control unit for the morcellator. With a cutting blade on the distal end, a rotating cylindrical tube is inserted in the abdominal cavity.
This document is a 510(k) summary for the NOUVAG AG Morcellator (Morce Power Plus / VarioCarve). The device is a surgical morcellator used in laparoscopic procedures.
Here's an analysis of the provided text in relation to acceptance criteria and device performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics explicitly stated for the NOUVAG AG Morcellator. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against predefined criteria.
The general statement regarding performance is:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety & Effectiveness | "The Morcellator has been designed and tested to applicable safety standards. The Morcellator does not raise any new issues of safety, effectiveness, or performance of the product." (Implicitly, it meets the safety, effectiveness, and performance standards of the predicate devices based on substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe any specific test set or clinical study with a defined sample size. The substantial equivalence claim is made based on the device's technological characteristics being similar to already legally marketed devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as there is no described test set requiring ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not applicable as there is no described test set.
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 conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on comparative effectiveness with or without AI assistance (which is not relevant to this type of device).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm-only) performance study was not conducted or reported. This device is a mechanical surgical instrument, not an AI or diagnostic algorithm, so this type of study is not relevant.
7. The Type of Ground Truth Used
This information is not applicable as there is no described test set requiring ground truth. The basis for clearance is substantial equivalence to predicate devices, implying that the established safety and effectiveness of the predicates serve as a "ground truth" for the new device's similar characteristics and intended use.
8. The Sample Size for the Training Set
There is no mention of a training set in this 510(k) summary. This type of device (surgical instrument) does not typically involve AI models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set.
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(101 days)
NOUVAG AG
The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.
The TCM Endo 20 is a transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor. It is a microprocessor controlled electronic motor system which controls the rotational speed and the torque of the motor. The rotational speed is constant until the torque reaches the adjusted level. In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode. The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting).
The provided text is a 510(k) summary for the NOUVAG AG TCM Endo 20 device. It states that the device is substantially equivalent to a previously cleared device (NOUVAG AG TCM Endo V K042822). The summary explicitly states: "The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product."
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Study for NOUVAG AG TCM Endo 20
This 510(k) submission for the NOUVAG AG TCM Endo 20 is for a dental root treatment device. As such, the primary method for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than a clinical study with detailed performance metrics and acceptance criteria as would be seen for novel or high-risk devices. The submission indicates that the device has been designed and tested to applicable safety standards and is substantially equivalent to other legally marketed devices in the United States and functions in a similar manner for the same intended use.
Therefore, the "acceptance criteria" here are generally related to meeting recognized safety standards and demonstrating that the device's technical characteristics and intended use are comparable to the predicate. The "study" proving this largely relies on engineering and performance testing to ensure it operates equivalently to the predicate, not a clinical trial measuring diagnostic accuracy or treatment efficacy.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical and electrical safety via applicable standards. | "The TCM Endo 20 has been designed and tested to applicable safety standards." |
| Functional equivalence to the predicate device (TCM Endo V K042822). | "The TCM Endo 20 functions in a manner similar and is intended for the same use as the TCM Endo V (Predicate device)." |
| No new issues of safety, effectiveness, or performance. | "The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product." |
| Compliance with regulatory requirements (GMP, labeling, etc.). | (Implicitly asserted by submitting for 510(k) clearance) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the traditional sense (e.g., patient data). The testing mentioned is primarily non-clinical, likely engineering and performance testing to verify adherence to safety standards and functional specifications. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable or provided for a clinical test set.
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)
This information is not applicable and not provided. The substantial equivalence argument relies on comparing device specifications and intended use to a predicate, not on a clinical ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set with adjudicated ground truth 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. This device is an endodontic motor, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this device filing, the "ground truth" for substantial equivalence is primarily the established safety and effectiveness profile of the predicate device, demonstrated through non-clinical testing against engineering specifications and applicable standards for the new device.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
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(168 days)
NOUVAG AG
The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.
The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action. Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m
The provided text is a 510(k) summary for the NOUVAG Dispenser DP 20, an infiltration pump. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria in the way you've outlined.
Therefore, the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.
The 510(k) summary does contain the following relevant points:
- Device Description and Intended Use: The Dispenser DP 20 is an infiltration pump intended for general surgical fluid irrigation and infiltration under physician control, using a peristaltic action. It is not for intravascular infusion.
- Predicate Devices: The document identifies two predicate devices:
- Substantial Equivalence Claim: The manufacturer claims substantial equivalence based on the principle of operation and technology (peristaltic action for fluid delivery) being similar to other irrigation devices previously cleared by the FDA.
- Nonclinical Testing: A brief summary states: "The Dispenser DP 20 has been designed and tested to applicable safety standards. The Dispenser DP 20 does not raise any new issues of safety, effectiveness, or performance of the product." This indicates some form of testing was done to safety standards, but no specific criteria or results are provided.
In summary, this 510(k) document is a regulatory submission focused on comparing technological characteristics and intended use to existing devices, not on providing a detailed performance study with quantifiable acceptance criteria and results as typically found for novel AI/diagnostic devices.
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(71 days)
NOUVAG AG
The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
The TCM Endo V is a transportable, cord connected, microprocessor-controlled endodontic device with Apex Locator. It is provided with a plastic enclosure which has four electrical connection ports for the detachable power supply cord, the foot-control, the micro-motor and the reference electrode (lip connector). The Apex Locator measures the distance between file tip and Apex. If a minimum distance is preselected, the selected auto-control mode is activated thus ensuring that the minimum distance is reached. The speed is held constantly under all circumstances until the maximum adjusted torque limit is reached. The Automatic Torque Control (ATC) protection mode ensures that no file breakage occurs. Once the preselected torque limit has been reached, the motor will immediately reverse for one revolution, then returns to forward direction. This ensures a fast and effective root canal preparation. The following parameters can be set by the user; - mains voltage (100V/115V/230V) - rotational speed (150-2000 rpm) - "Apex adjust" (-1 to 0) - automatic torque limitation "ATC" (5-40Nmm) - "Auto control" mode ("Auto Slow / Down", "Auto Reverse"; "Auto Stop") - micro-motor ON/OFF "Motor"
This 510(k) premarket notification for the NOUVAG AG TCM Endo V does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance.
This document is a 510(k) summary, which is a high-level overview submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically focuses on the device's intended use, technological characteristics, and a brief summary of non-clinical tests.
Here's why the requested information is not present in the provided text:
- Acceptance Criteria and Reported Device Performance: This document states that "The TCM Endo V has been designed and tested to applicable safety standards." and "The TCM Endo V does not raise any new issues of safety, effectiveness, or performance of the product." However, it does not provide specific acceptance criteria (e.g., accuracy percentages, specific tolerances for apex localization) or report the results of any specific performance studies against those criteria. Such details would typically be found in a more comprehensive device validation report, which is part of the full 510(k) submission but not usually included in the publicly available summary.
- Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details: These are all aspects related to a detailed clinical or performance study. The provided text is a regulatory summary and does not include the methodology or results of any such studies. The device is for "dental root canal measurement and treatment" and mentions an "Apex Locator," implying that accuracy in length measurement would be critical, but no data on this is presented.
Based only on the provided text, I cannot complete the table or answer the specific questions about the study. The summary aims to establish substantial equivalence for regulatory purposes, not to present detailed scientific performance data.
The FDA's decision letter (K042822) confirms the substantial equivalence based on the submitted information, but it also does not contain the detailed study results.
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(53 days)
NOUVAG AG
The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient 's bedside.
Every model has at least one suction jar with overflow safety device, bacterial filter and optional a castered troiley. The optional foot switch can be used to activate the suction opinonal a castered a most can be continuously regulated by a valve and monitored through the manometer.
Vacuson 40 and Vacuson 60 are different in the maximum suction flow rate.
The Vacuson 40 has a built-in piston pump with the name "P40". The maximum suction flow rate for the Vacuson 40 Device is specified with 40 litres/min.
The Vacuson 60 has a built-in piston pump with the name "P70". The maximum suction flow rate for the Vacuson 60 Device is specified with 60 litres/min.
Sterility:
Suction tube, Suction jars with jar lids: Sterility by user up to 134°C.
This K042943 submission for the NOUVAG AG Vacuson 40 and Vacuson 60 is a 510(k) premarket notification. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on a comprehensive de novo validation study with specific acceptance criteria and detailed performance reporting.
Based on the provided information, here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense for a 510(k) submission of this nature. 510(k)s for devices like powered suction pumps often rely on demonstrating adherence to recognized standards and direct comparison of functional specifications to a legally marketed predicate device.
The brief summary of nonclinical tests states: "The Vacuson 40 and Vacuson 60 have been designed and tested to applicable safety standards. The Vacuson 40 and Vacuson 60 do not raise any new issues of safety, effectiveness, or performance of the product." This indicates an implicit acceptance criterion of meeting applicable safety standards and performing similarly to the predicate without introducing new risks.
Key Performance Specifications (from Device Description):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maximum Suction Flow Rate: | |
| Vacuson 40 | 40 litres/min |
| Vacuson 60 | 60 litres/min |
| Sterility: | Sterility by user up to 134°C for suction tube, suction jars with jar lids. |
| Operational Mechanism: | Continuously regulatable suction by a valve, monitored through a manometer. |
| Safety Features: | At least one suction jar with overflow safety device, bacterial filter. |
2. Sample Size Used for the Test Set and Data Provenance
Not specified. This type of detail is not typically included in a 510(k) summary for a powered suction pump where testing is more focused on engineering specifications and adherence to standards rather than a clinical "test set" in the context of diagnostic accuracy. The testing would primarily involve laboratory measurements of flow rates, pressure, and safety features.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for a device like a powered suction pump would be its engineering specifications and performance against industry standards, not expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of a test set requiring adjudication in the context of this device and submission type.
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 powered suction pump, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm. Performance would be assessed in terms of its mechanical function (suction power, flow rate) in a standalone manner, separate from human operation, to meet its specifications.
7. The Type of Ground Truth Used
The ground truth used for this type of device would be its engineering specifications and performance against recognized industry standards. This includes:
- Measurement of maximum suction flow rate.
- Verification of overflow safety device functionality.
- Confirmation of bacterial filter efficacy (if applicable to the device, or specified for the filter itself).
- Temperature resistance for sterilization.
- Compliance with electrical safety and electromagnetic compatibility (EMC) standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
In summary:
This 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Medela AG Medela "Basic 30" and "Dominant 50" Suction Pumps K021368) by showing similar intended use, technological characteristics, and adherence to applicable safety standards. The information provided is typical for a summary of a traditional medical device's premarket notification, where the "study" is often a series of engineering tests and comparisons rather than a clinical trial with acceptance criteria defined by diagnostic accuracy metrics.
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(56 days)
NOUVAG AG
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(429 days)
NOUVAG AG
Indications are widespread in the field of Surgery, Implantology and Endodontic treatment.
- Surgery: 1059, 5050, 5051, 5055, 5056, 5060, 5062, 5063, 5068, 5070, 5075
- . Endodontic treatment: 5057, 5059, 5061, 5066, 5067, 5069, 5071, 5076
- . Speed Increaser Contra-Angle: 5081 The device is intended for use where high speed such as 200'000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cuttin and/or finishing of dentures, denture bases, crowns, inlays and metal plates
All devices are driven by an electric micromotor handpiece that has the ISO-3964 Coupling.
All mentioned NOUVAG Contra-Angle Attachments Dental are attachments for surgical drive units. They are designed to transmit rotational movement of the motor axle of such drive units to the shank of a bur which will be inserted into the output end of the handpiece.
For this application, all these Contra-Angle Attachments contain a coupling part fittable to all surgical motors with a coupling according to ISO 3964.
The output end of the Contra-Angle Attachments contains chuck systems for accommondation of standardized bur shanks. All mentioned NOUVAG Contra-Angle Attachments Dental are designed for burs according to ISO 1797 shank-type 1.
The provided text is a 510(k) submission for NOUVAG Contra-Angle Attachments Dental. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way envisioned for a typical AI/software device.
The submission focuses on demonstrating substantial equivalence to existing legally marketed dental handpiece attachments. The "performance" aspect mentioned refers to compliance with established international standards for mechanical characteristics and usability, rather than performance in terms of diagnostic accuracy or clinical outcomes as would be relevant for an AI study.
Therefore, I cannot fulfill the request in the format provided because the information is not present in the input document.
Here's a breakdown of why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance. Instead, the submission implies acceptance criteria are met by conforming to existing international standards for dental instruments (ISO 7785-2, ISO 3964, ISO 10993-1/-5/-12).
- Reported Device Performance: The "Performance" row in the TABLE 1 TECHNOLOGICAL COMPARISON refers to compliance with ISO 7785-2 and ISO 3964. This indicates the device meets the mechanical and functional specifications outlined by these standards, making it comparable to the predicate devices.
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. This document describes a traditional medical device (mechanical dental handpiece attachments), not an AI/software device. There is no "test set" of data in the AI sense for clinical validation. Testing would primarily involve mechanical and material property verification against the aforementioned ISO standards.
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. No ground truth establishment for a diagnostic or clinical AI application. The "ground truth" for this device would be its adherence to engineering specifications and international standards, likely verified by engineers or quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a clinical test set.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the AI sense. The "ground truth" for this device's safety and effectiveness is its compliance with established engineering standards (ISO) and its substantial equivalence to predicate devices already on the market.
8. The sample size for the training set:
- Not applicable. No training set for an AI model.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
In summary: The provided 510(k) notification is for a mechanical medical device and therefore does not contain the types of information requested concerning AI acceptance criteria, studies, and data sets. The equivalence is demonstrated through comparison of material, design, intended use, and compliance with recognized performance standards to predicate devices.
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(65 days)
NOUVAG AG
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation.
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation. The motor has a maximum 1:1 drive output of 16,000 Rpm's. The unit is supplied with either a 115V or 230V power cord. The entire motor assembly of the TCM Endo III is autoclavable.
The provided text is a 510(k) summary for the TCM Endo III, an AC-powered dental handpiece. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement that would be required to answer the specific questions posed.
Therefore, I cannot provide the requested information from the given text. The document is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.
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(70 days)
NOUVAG AG
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(272 days)
NOUVAG AG
Nouvag AG's ("Nouvag") TCM 3000 and TCM Endo is a microprocessorcontrolled dental hand piece with controlled electric motor-torque. The TCM 3000 and TCM Endo is intended to be used for dental drilling and tightening of the various types of screws during dental implantation and microsurgery.
The TCM 3000's and TCM Endo's primary components are (1) a console; (2) a motor; (3) a microprocessor; (4) a foot pedal; and (5) an electric cord and plug. The TCM 3000 and TCM Endo is not supplied with dental drills or contra-angles or contra-angles torque wrenches, which are also called dental hand pieces. The Micromotor has a standard E-Type coupling that will fit any E-Type hand pieces and contra-angles.
The console houses the microprocessor and the motor. The buttons for setting the motor speed, contra-angle reduction ratio, motor torque are located on the front panel of the console. The buttons that may be used to start and stop the motor and change the cut-direction of the drill also are located on the front panel. The port connections for the contra-angles and the foot pedal and the main power switch are located on the back of the console.
A lever is located on the foot pedal for starting and stopping the motor. For the second version of the foot pedal the lever also can adjust the motor speed. The TCM 3000/Endo contains an audible alarm that sounds when the drill is turning in the reverse- cut direction.
The TCM 3000/Endo requires an AC current of 115V or 230V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is attached to the back of the console.
The provided document is a 510(k) summary for the Nouvag AG's TCM 3000/Endo device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria and performance results in the way a novel device might. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not typically found in this kind of regulatory filing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain specific quantitative acceptance criteria or a table of reported device performance in the context of a clinical study. The basis for clearance is "substantial equivalence" to a predicate device, meaning it's demonstrated to be as safe and effective as a device already on the market.
2. Sample Size Used for the Test Set and Data Provenance:
No test set (in the context of a clinical trial for performance evaluation) is mentioned. The submission relies on a comparison of technological characteristics and intended use to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No ground truth for a test set was established as part of this submission.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This device is a mechanical dental instrument, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
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.
7. The Type of Ground Truth Used:
Not applicable. The submission is based on substantial equivalence, not on establishing a new ground truth for a novel device's performance. The "ground truth" in this context is the safety and effectiveness of the predicate device, which has a "long history of safe use."
8. The Sample Size for the Training Set:
Not applicable. No training set for an algorithm was used.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set for an algorithm was used.
Summary of Device Acceptance Criteria (Implied by Substantial Equivalence):
While not explicitly stated as "acceptance criteria," the submission argues that the TCM 3000/Endo meets the following for substantial equivalence to the NOUVAG's Micro-Dispenser 7000 and 8000 (K954722):
| Criterion Category | Implied Acceptance |
|---|---|
| Intended Use | The device is substantially equivalent if its intended use is for "microprocessor-controlled dental drilling and torque-controlled system," similar to the predicate. |
Reported Performance/Claim: "The TCM 3000/Endo and the Micro-Dispenser 7000/8000 have the same general intended use: microprocessor-controlled dental drilling and torque-controlled system." |
| Indications for Use | The device is substantially equivalent if its indications are similar to the predicate, specifically for "dental implantation and microsurgery."
Reported Performance/Claim: "These devices also have very similar indications: dental implantation and oral or microsurgery." |
| Technological Characteristics | The device is substantially equivalent if its primary components (console, motor, microprocessor, foot pedal, electric cord), standard E-Type coupling, and operational features (buttons for speed/ratio/torque, start/stop, cut-direction, audible alarm for reverse operation, AC current requirement) are similar to the predicate. Minor differences should not raise new safety or effectiveness concerns.
Reported Performance/Claim: "The TCM 3000/Endo and the Micro-Dispenser have very similar technological characteristics. More specifically, these dental drilling systems have the following features: (1) buttons on the console... (2) a foot pedal... (3) motor torques that are preset... (4) safety-overload protection; and (5) they require AC current. Both are microprocessor controlled. Neither device is supplied with drills or contra-angles. Both devices can be used with any E-type contra-angles. Although there are some minor differences in their technological characteristics... These differences do not present any new issues of safety or effectiveness." |
| Principles of Operation | The device is substantially equivalent if its operational principles—setting motor speed, contra-angle reduction ratio, motor torque, AS-Torque-Driver Mode, starting/stopping with foot pedal/buttons, forward/reverse cut direction—are similar to the predicate.
Reported Performance/Claim: "In addition, these devices have the same principles of operation. The operator of the device sets the motor speed, contra-angle reduction ratio, and the torque-levels and operates the drill by pushing buttons on the console or on the foot pedal." |
| Safety and Effectiveness | The device is substantially equivalent if its safety and effectiveness are based on the predicate device's established record, and any differences do not raise new safety or effectiveness concerns.
Reported Performance/Claim: "The safety or effectiveness of the TCM 3000/Endo is based on the safety or efficacy of the predicate device... These differences do not present any new issues of safety or effectiveness. Thus, the TCM 3000/Endo is substantially equivalent to the Micro-Dispenser 7000/8000." Bio-compatibility of non-supplied components (drills, contra-angles) is covered by their "long history of safe use." |
Study Proving Device Meets Acceptance Criteria:
The "study" that proves the device meets the acceptance criteria is a comparison to a predicate device (NOUVAG's Micro-Dispenser 7000 and 8000, K954722) to establish substantial equivalence. This is a regulatory pathway that relies on demonstrating that the new device has the same intended use, similar technological characteristics, and similar principles of operation as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
Key conclusions from the submission:
- The TCM 3000/Endo is declared substantially equivalent to the predicate device because:
- They share the same general intended use and very similar indications.
- They have very similar technological characteristics (e.g., microprocessor-controlled, buttons for settings, foot pedal, safety features, E-type compatibility, AC current).
- They operate on the same principles.
- Minor differences (e.g., specific contra-angle reduction-ratios, pre-selectable torque levels, irrigation pump, foot control variation) do not introduce new issues of safety or effectiveness.
- The biocompatibility of components (drills and contra-angles) not supplied with the device is addressed by their "long history of safe use."
In essence, the "study" is the 510(k) submission itself, which systematically compares the new device to the predicate across various attributes to demonstrate that it meets the regulatory standard of substantial equivalence. This is not a clinical trial in the traditional sense, but rather a regulatory assessment.
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