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510(k) Data Aggregation
(278 days)
J. Morita USA, Inc.
The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is composed of the aforementioned corresponding modules.
The apex locating function of Root ZX3 device is used for root canal measurement and working length determination.
The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty, gingivectomy, hemostasis, pulpotomy as an adjunct to root canal therapy, and excision of intraoral lesions. It is also used for the ablation of pulp, dental filling material (e.g. gutta-percha) and tissue in/around root canals as an adjunct to root canal therapy, after determining the tip position of the active electrode by apex location.
The Root ZX3 device (also referred to by its model number RZX3) is a battery-driven apex locator with an optional dental electrosurgical unit, used in the oral cavity during dental procedures. This device has two modules: the main module is an apex locator module and the other is an electrosurgical module (high frequency [HF] module). The apex locator module is the basic module to which dental electrosurgical functions can be added by connecting the HF module.
The provided text describes the 510(k) summary for the Root ZX3 dental device, which includes an apex locating function and an optional electrosurgical function. The document details the device's characteristics, intended use, and substantial equivalence to predicate devices, supported by non-clinical testing.
However, the provided text does not contain any information about specific acceptance criteria for a study showing device performance, or any detailed study results proving the device meets acceptance criteria. It states "No clinical tests were performed for the Root ZX3 device" and that "A performance test was conducted to confirm that Root ZX3 can locate the apex using the method that is substantially equivalent to the reference predicate devices. The high-frequency performance of this device was substantially equally to that of predicate devices, as shown in Table 2 (Comparison chart)."
The document focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to various safety and performance standards. It does not present a formal study with defined acceptance criteria and corresponding performance metrics for the Root ZX3 in the way a clinical or standalone performance study for an AI/CADe device would.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided text, as the necessary information (specific performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not present. Based on the provided information, the device's performance was evaluated through non-clinical testing and comparison to predicate devices to establish substantial equivalence.
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(268 days)
J. Morita USA, INC.
The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography.
The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dentomaxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations.
The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients.
The X800N consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction.
The X800N has three main radiographic modes as follows:
- Panoramic tomography including linear tomography and scanogram -
- Cephalometric radiography -
- -Cone beam computed tomography
This document describes the 510(k) premarket notification for the J. Morita USA, Inc. 3D Accuitomo 150N Model X800N, an X-ray system for panoramic, cephalometric, and CBCT imaging. The primary purpose of this submission is to obtain clearance for a new ENT (Ear, Nose, and Throat) indication for an already cleared device, the Veraview X800 (K#171012).
An important note for this response: The provided text details the device itself and its equivalence to a predicate device, as well as the clinical evaluation performed for the new indication for use. However, it does not describe acceptance criteria for an AI/CADe device's performance. The clinical evaluation described here is to demonstrate the image quality of the X800N for ENT diagnosis is comparable to existing devices, not to validate an AI algorithm's diagnostic performance against specific metrics like sensitivity or specificity. Therefore, many of the requested points regarding AI acceptance criteria and studies cannot be addressed from the given text.
Here's an analysis based on the provided information, addressing what is present and noting what is absent:
Acceptance Criteria and Study for the 3D Accuitomo 150N Model X800N (K201378)
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for a medical imaging device (CT scanner) and not an AI/CADe device, the "acceptance criteria" presented are related to image quality and comparability to predicate devices, rather than performance metrics for an algorithm (e.g., sensitivity, specificity, AUC). The study aims to demonstrate that the image quality of the X800N is sufficient for the expanded ENT indication.
| Criterion Type | Acceptance Criteria (Stated Goal) | Reported Device Performance (Study Results) |
|---|---|---|
| Clinical Acceptability for ENT Diagnosis | The CT images obtained by the X800N for general examination and diagnosis of the ENT area should be substantially equivalent to or better than those obtained by the reference devices (X550 and MCT-1) for this indication. | All evaluators ranked the images of the X800N as "Excellent Quality for Diagnosis" or "Acceptable Quality for Diagnosis." The overall results for X800N were reported as "better than that of the X550" and "comparable to the MCT-1." This supports sufficiency for ENT diagnosis. |
Missing Information: There are no quantitative acceptance criteria for AI algorithm performance (e.g., specific thresholds for sensitivity, specificity, F1-score, or agreement rates) because this is not an AI/CADe device submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states that "skull phantoms made from resin molding on real human dry skulls" were used. It does not provide the specific number of phantoms or images in the test set.
- Data Provenance:
- Country of Origin: The images were obtained in "J. Morita's facility." The company (J. Morita USA, Inc.) is located in Irvine, CA, USA, suggesting the facility is likely in the USA. The manufacturer is "J. MORITA MFG. CORP." (not specified where this is located, but typically these are from Japan for J. Morita).
- Retrospective or Prospective: The use of phantoms implies a prospective acquisition specifically for this evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The text states, "Experienced doctors who are using CBCT for their ENT medical practice subjectively evaluated images..." It does not specify the exact number of doctors.
- Qualifications: "Experienced doctors who are using CBCT for their ENT medical practice." Specific experience (e.g., years, board certification) is not detailed beyond "experienced" and "using CBCT for their ENT medical practice."
4. Adjudication Method for the Test Set
- Adjudication Method: The text indicates that experts "subjectively evaluated images" and "ranked by the evaluators according to five categories." It does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus, or independent arbitration) if there were discrepancies between evaluators. It implies individual evaluations were then aggregated to determine overall results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: While multiple readers (the "experienced doctors") evaluated multiple "cases" (skull phantoms/images), this was not an MRMC study comparing human performance with and without AI assistance. It was a subjective evaluation by human readers of image quality from different devices.
- Effect Size: Not applicable, as there was no AI assistance and no comparison of human reader performance with/without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is an imaging system, not an AI algorithm. The "performance" being evaluated is the image quality produced by the system for human interpretation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this evaluation was essentially expert subjective evaluation of image quality and diagnostic suitability. The phantoms themselves provide a known anatomical structure, which serves as a "true" anatomical baseline against which the image quality is judged for its clarity and accuracy for ENT diagnosis. It is not "pathology" or "outcomes data" in the traditional sense, but rather "fitness for purpose" as judged by experts.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an imaging system, not an AI algorithm that requires a training set. The device's "training" involves engineering and design, informed by physics and medical requirements, not machine learning from image datasets.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no AI training set for this device.
Summary of Scope and Missing AI-Specific Details:
The provided document describes a 510(k) submission for a conventional medical imaging device (CBCT scanner) with an expanded indication for use (ENT). The "clinical testing" performed was an evaluation of the image quality produced by the device, judged subjectively by medical experts, to demonstrate its suitability for the new indication compared to existing cleared devices.
Crucially, this document does not pertain to an AI/CADe device or an AI algorithm’s performance validation. Therefore, many of the requested points related to AI acceptance criteria, training sets, and human-in-the-loop studies (beyond clinicians interpreting images) are not present in the provided text. The "acceptance criteria" here are implicitly showing that the images are of sufficient quality for an experienced clinician to make a diagnosis, similar to images from currently cleared devices.
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(369 days)
J. Morita USA, Inc.
The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.
The Lubrina 2 device is used to maintain optimum performance and prolong the working life of dental handpieces. The Lubrina 2 delivers oil and air automatically to handpieces, and is used after dental treatment and before autoclaving. The Lubrina 2 is not installed in a dental operative unit, but rather is to be used on a table or shelf.
There is only one model. The type varies depending on the country/area the device is to be shipped to and the power cord for that region is included in the package. For the USA, only model HIM-2 Type US, is to be marketed, together with the power cord for the USA.
Operating Mechanism:
The Lubrina 2 supplies lubrication oil to the inside of handpieces by automatically discharging pressurized air from spray can lubricant. Excess oil is removed from the handpiece by pressurized air.
The Lubrina 2 has four operation modes:
- Chuck Lubrication
- Handpiece Body Lubrication
- Flushing (Extended lubrication)
- Air blow mode
The provided text is a 510(k) premarket notification for the Lubrina 2, a dental handpiece accessory maintenance device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than novel performance benchmarks. Therefore, it does not contain the typical "acceptance criteria" and "device performance" in the way one might expect for a diagnostic or therapeutic medical device measured by clinical metrics.
Instead, the acceptance criteria are implicitly met by demonstrating that the Lubrina 2 is substantially equivalent to its predicate device, the Lubrina (Model HIM-1, K#070074), and by conforming to relevant international standards. The "study" that proves the device meets these criteria is a combination of non-clinical bench testing and a comparison of technological characteristics.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Substantially identical to predicate: Lubricating and cleaning the inside of dental instruments. | "Substantially identical" to predicate. Lubrina 2 is for lubricating and cleaning the inside of dental instruments. |
| Manufacturer | Identical to predicate. | Identical (J. MORITA MFG. CORP.) |
| Target Population | Identical to predicate: Dentist, doctor, dental hygienist or medical staff. Not for patient use. | Identical. Dentist, doctor, dental hygienist or medical staff. Not for patient use. |
| Where Used | Identical to predicate: Dental clinic, university hospital, and other clinical settings. | Identical. Dental clinic, university hospital, and other clinical settings. |
| Energy Used/Delivered | Identical to predicate: Rating AC100-240V, Input 10-25VA, Voltage 100-240V, Frequency 50/60Hz, Air Pressure 0.3-0.5MPa. | Identical to predicate. |
| Design (Size) | Similar to predicate (minor size difference W300×D300×H365mm vs W300×D300×H370mm). | Similar. Lubrina 2: W300xD300xH365mm. Predicate: W300xD300xH370mm. |
| Performance (Processing Time) | Similar to predicate, with potential for improvement. | Similar. Reduced processing time (40sec/piece) compared to predicate (120sec/piece). Reduced operating noise. |
| Standards Met | Identical to predicate in key standards: ISO 14971, IEC 62366, ISO 152231, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304. | Identical set of standards met. |
| Materials | Similar to predicate, no new questions of safety or effectiveness. | Similar, but with minor differences (e.g., Hot-dip zinc-coated steel vs Cold reduced carbon steel sheets, PBT/ABS vs ASA). These differences do not raise new safety/effectiveness questions. |
| Electrical Safety | In accordance with IEC60601-1, EN 62304, and ISO 14971. | In accordance with these standards. |
| Radiation Safety | In accordance with IEC60601-1-2. | In accordance with IEC60601-1-2. |
| Mechanical Safety | In accordance with IEC60601-1 and ISO 14971. | In accordance with these standards. |
| Thermal Safety | In accordance with IEC60601-1. | In accordance with IEC60601-1. |
| Anatomical Sites | Not applicable, identical to predicate. | Not applicable. Device not used on patient. |
| Sterility | Not applicable, identical to predicate. | Not applicable. Device not used on patient. |
| Human Factors | In accordance with IEC62366. | In accordance with IEC62366. |
| Compatibility with Environment and Other Devices | Conform to IEC60601-1-2. | Conform to IEC60601-1-2. |
| Functionality (Lubrication/Cleaning) | Capable of lubrication and cleaning handpieces. | Performance bench testing confirmed capability of lubrication and cleaning handpieces. |
| Compatibility with Lubricating Cans | Demonstrated compatibility with various lubricating cans. | Performance bench testing demonstrated compatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices or number of tests conducted. The document states "Testing was conducted to confirm that the device is capable of lubrication and cleaning handpieces" and "Performance bench testing was conducted to demonstrate the compatibility of the device with various lubricating cans." Specific quantities of tests or handpieces are not provided.
- Data Provenance: The tests are non-clinical bench tests, likely performed in a controlled laboratory environment by the manufacturer (J. Morita MFG. CORP). The country of origin for the testing is not explicitly stated, but the manufacturer is J. Morita MFG. CORP. (Japan), though J. Morita USA, Inc. is the submitter. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. For a 510(k) submission of a device like Lubrina 2, which is an accessory maintenance device, ground truth in the sense of expert medical diagnosis or pathology is not relevant. The "ground truth" here is adherence to engineering standards and demonstrated functionality through bench testing.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a medical ground truth, for example, in imaging diagnostics. For a device like Lubrina 2, which is assessed through engineering and performance bench tests, such adjudication is not relevant.
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. Such studies are typical for AI-powered diagnostic devices where human reader performance is a key metric. This device is a mechanical accessory maintenance unit.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the Lubrina 2 is a mechanical device for cleaning and lubricating dental handpieces, not an algorithm, and does not involve human-in-the-loop performance in the context of an AI-driven system. Its performance is standalone in the sense that its function (lubricating and cleaning) does not directly involve human intervention during the process itself, but it's not an "algorithm only" performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through engineering standards, functional bench testing, and comparison to the predicate device's established performance. It's not based on expert consensus, pathology, or outcomes data in a clinical sense. The device's ability to lubricate and clean handpieces, its electrical safety, electromagnetic compatibility, usability properties, and adherence to risk management principles constitute the "ground truth" that it performs as intended and is as safe/effective as the predicate.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Lubrina 2 is a mechanical accessory maintenance device and does not utilize a "training set" in the context of machine learning or artificial intelligence.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As the device does not employ a "training set," there is no ground truth to be established for it.
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(293 days)
J. Morita USA, Inc.
LS OIL is a lubricant and is intended for use to lubricate dental handpieces.
LS OIL is a lubricant intended for use with dental handpieces. It is comprised of the same paraffin oil and oiliness improver (fatty acid ester) as the previouslycleared LS SPRAY reference device. LS OIL is used after clinical use of dental handpieces before sterilization. It is directly added to the devices from its nozzle by dropping into inside of the handpieces. The LS OIL goes through the hollow of the devices and lubricates their components (gears, bearing, and rotating parts).
I am sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and a study proving device performance as it relates to an AI/ML device.
The document is a 510(k) Premarket Notification for a dental handpiece lubricant called "LS OIL." It discusses:
- Device Name: LS OIL
- Intended Use: Lubricating dental handpieces
- Comparison to a Predicate Device and Reference Device: PANA-SPRAY and LS SPRAY, respectively.
- Technological Characteristics: Paraffin oil and fatty acid ester composition.
- Non-clinical Testing: Viscosity, solubility, density, color, performance testing (sound/vibration after simulated use), shelf life, and biocompatibility (cytotoxicity, irritation, sensitization).
- No Clinical Testing.
There is no mention of:
- AI or machine learning algorithms.
- Acceptance criteria for an AI/ML device's performance (e.g., sensitivity, specificity, AUC).
- A test set, training set, or data provenance for an AI/ML model.
- Experts establishing ground truth for AI/ML performance.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies.
- Standalone AI performance.
- Effect size of human reader improvement with AI assistance.
- Ground truth types in the context of diagnostic AI.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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(224 days)
J. MORITA USA, INC.
The Tri Auto ZX2 device is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
The Tri Auto ZX2 is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file and reamer. The Tri Auto ZX2 can be used for cutting and grinding teeth by transferring rotary movement to a rotary instrument attached to the head. Cutting and grinding of teeth can be done depending on the situation by switching (reversing) the rotation direction. Rotation speed is accelerated or decelerated according to the user's preference, rotation control based on torque detection, or set timing. These controls enable the cutting, grinding, enlargement, and preparation of root canals. Moreover, the Tri Auto ZX2 can be used for the removal of extraneous materials such as gutta-percha points, and for professional mechanical tooth cleaning. In addition, the Tri Auto ZX2 can be used as an apex locator, and the measured value can be used for rotation control. The Tri Auto ZX2 is intended to be sterilized prior to use.
The provided text is a 510(k) Summary for the Tri Auto ZX2, a dental device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined ground truth. Therefore, much of the requested information regarding acceptance criteria, sample size for test sets, expert involvement, and ground truth establishment is not directly applicable or available in this type of document.
However, I can extract the information that is present and indicate where the requested details are not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the Tri Auto ZX2 as performance metrics to be proven against in a standalone study. Instead, it compares the device's technological characteristics to predicate devices to demonstrate substantial equivalence. The "performance" section within the comparison table implicitly serves as a form of performance criteria.
| Feature | Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance (Tri Auto ZX2) |
|---|---|---|
| Canal Enlargement Performance | Rotation speed and torque comparable to predicate devices (Tri Auto ZX: 280rpm, 4.5Ncm (min.); Tri Auto mini: 50-1,000rpm, 4Ncm (min.)). | Engine Performance: 100-1,000rpm, 4Ncm (min.). |
| Apex Locator Accuracy | Accuracy of the root apex locator function: -1.5mm to +0.5mm for Apex position (same as Tri Auto ZX). | Accuracy of the root apex locator function: -1.5mm to +0.5mm for Apex position. |
| Materials | Used materials conform to ISO10993. | Used materials conform to ISO10993. |
| Sterility | Autoclavability of file holder, contrary electrode, and contra angle (same as Tri Auto ZX). | File holder, contrary electrode, and contra Angle are autoclavable. |
| Electrical Safety | Conform to IEC60601-1. | Conform to IEC60601-1. |
| Electromagnetic Compatibility | Conform to IEC60601-1-2. | Conform to IEC60601-1-2. |
| Usability | Conform to IEC 60601-1-6 and IEC 62366. | Conform to IEC 60601-1-6 and IEC 62366. |
| Software | Conform to IEC 62304. | Conform to IEC 62304. |
| Risk Management | Conform to ISO 14971. | Conform to ISO 14971. |
| Biological Evaluation | Conform to ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-12 (sample preparation). Materials used in contra angle (polyphenylsulfone (PPSU)) and disposable cover (polypropylene) pass biocompatibility testing. | Conform to ISO 10993-1, ISO 10993-5, ISO 10993-12. Biocompatibility testing conducted for PPSU and polypropylene. |
| Sterilization | Conform to ISO 17664, ISO 17665-1, ISO 17665-2. | Conform to ISO 17664, ISO 17665-1, ISO 17665-2. |
| Handpiece Standards | Conform to ISO 14457. | Conform to ISO 14457. |
2. Sample size used for the test set and the data provenance
The document states, "Performance testing was conducted to confirm that the device is capable of measuring and enlarging root canals in a manner that is substantially equivalent to the primary predicate and reference predicate devices." However, it does not specify the sample size for this performance testing, nor does it provide details on the data provenance (e.g., country of origin of the data, retrospective or prospective). This would typically be found in a detailed study report, not a 510(k) summary.
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 in the 510(k) summary. Given that testing was for technical functions like rotation speed, torque, and apex locator accuracy, it is likely that engineering measurements and established reference methods were used rather than expert human assessment for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the type of in-vitro, engineering-focused performance testing described for this device. Adjudication methods are more common in clinical studies where human interpretation of results is involved.
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
The Tri Auto ZX2 is a physical dental handpiece with an integrated apex locator, not an AI-powered diagnostic imaging device. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "Performance testing was conducted to confirm that the device is capable of measuring and enlarging root canals..." This implies standalone performance testing of the device's functions. However, it's not an "algorithm only" device in the context of AI, but rather a physical instrument. The "algorithm" for apex location is embedded. The results of this testing led to the claims of achieving the "Accuracy of the root apex locator function: -1.5mm to +0.5mm for Apex position" and the specified engine performance. Details of the methodology and results would be in the full test reports, not the summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The formal "ground truth" as typically defined for diagnostic AI is not explicitly stated for the performance testing. For the apex locator function, ground truth would likely be established through physical measurements against known lengths in standardized root canal models or extracted teeth, using precise tools, and for the motor, it would be direct engineering measurements of RPM and torque. This is based on the nature of the device's functions, which are quantifiable physical properties rather than subjective interpretations.
8. The sample size for the training set
The device is a physical instrument with embedded control logic (not a machine learning AI), therefore, the concept of a "training set" in the context of AI development does not apply. The device's control system and apex locator function are based on established engineering principles and algorithms, likely developed through R&D and traditional software engineering, not machine learning training.
9. How the ground truth for the training set was established
As the concept of a "training set" for AI does not apply to this device artifact, the establishment of ground truth for a training set is not applicable.
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(170 days)
J. MORITA USA, INC.
Device is intended for the incision, excision, vaporization, ablation and coagulation of soft tissue in oral and dentistry and for the ablation and vaporization of hard tissue in dentistry.
Hard Tissue
General Indications*
· Class I, II, III, IV and V cavity preparation
· Caries removal
· Hard tissue surface roughening or etching
· Enameloplasty, excavation of pits and fissures for placement of sealants
- For use on adult and pediatric patients
Root Canal Hard Tissue Indications
· Tooth preparation to obtain access to root canal
· Root canal preparation including enlargement
· Root canal debridement and cleaning
Bone Surgical Indications
· Cutting, shaving, contouring and resection of oral osseous tissues (bone)
· Osteotomy
Endodontic Surgery (Root Amputation) Indications
· Flap preparation - incision of soft tissue to prepare a flap and expose the bone.
· Cutting bone to prepare a window access to the apex (apices) of the root(s).
· Apicoectomy - amputation of the root end.
· Root end preparation for retrofill amalgam or composite.
· Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex.
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
Laser Periodontal Procedures
· Full thickness flap
· Partial thickness flap
· Split thickness flap
· Laser soft tissue curettage
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
· Removal of granulation tissue from bony defects
· Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
· Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
· Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
· Osseous crown lengthening
· Removal of subgingival calculus
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
· Excisional and incisional biopsies
· Exposure of unerupted teeth
· Fibroma removal
· Flap preparation incision of soft tissue to prepare a flap and expose the bone.
· Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
· Frenectomy and frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis and coagulation
· Implant recovery
· Incision and drainage of abscesses
· Incision and drainage of periapical abscesses
· Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy
· Pulp extirpation
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex .
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
· Root canal debridement and cleaning
· Soft tissue crown lengthening
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Vestibuloplasty
- For use on adult and pediatric patients
Equipment is mobile Er: YAG Medical Treatment and Coagulation Laser of model MEY-1-A intended to be used for dental surgery in hospital environment. Er.YAG Laser emits an infrared beam with a wavelength 2.94 um which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, a energy of the laser beam instantly vaporized the water molecules in hard tissues of the tooth causing the tissues to crumble away or resection of the soft tissues of gingival.
This document is a 510(k) summary for the AdvErL EVO Er: YAG Laser for Dentistry (Model: MEY-1-A). It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense for diagnostic accuracy.
The performance of the MEY-1-A is examined by using international standards for medical electrical equipment and laser products to ensure safety and essential performance. The document does not describe a clinical study comparing the device's efficacy against specific acceptance criteria for a diagnostic or therapeutic outcome. Instead, it relies on demonstrating that the device has the "substantially same equivalent technical specifications" and "intended use and Indications of use" as its predicate devices, implying that if the predicates met their performance criteria, this device would as well.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards: | |
| IEC 60601-1:2005 (General requirements for basic safety and essential performance) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| IEC 60601-2-22 (Particular requirements for safety of diagnostic and therapeutic laser equipment) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| IEC 60825-1 (Safety of laser products-Part 1: Equipment classification and requirements) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| IEC 60601-1-2:2007 (Electromagnetic compatibility - equipments and tests Edition 3) | The device's performance was examined using this standard. (Implied compliance for substantial equivalence) |
| Intended Use & Indications: | |
| Identical intended use and indications of use as predicate device I ("VERSAWAVE DENTAL ER: YAG LASER SYSTEM (K#041710)") | The MEY-1-A has the same "intended use and Indications of use" as predicate device I, except for "Removal of subgingival calculus." |
| Substantially similar intended use and indications of use as predicate device II ("WATERLASE MD TURBO PLUS MODEL 7200XXX (K#101658)") | The MEY-1-A has substantially similar "intended use and Indications of use" as predicate device II, but lacks the indication of "Root canal indications / Laser root canal disinfection after endodontic." |
| Technical Specifications: | |
| Substantially same "equivalent technical specifications" as predicate device I and II | The MEY-1-A has "substantially same 'equivalent technical specifications'" compared with both predicate devices. Minor differences in display, power calibration, and software are considered not to cause substantial impacts to effectiveness or safety. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical performance study with a test set of data in the context of diagnostic or therapeutic accuracy, but rather compliance with safety and electrical standards. Therefore, information on sample size and data provenance for a test set is not applicable here. The "test set" in this context refers to the device itself undergoing engineering and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth for a diagnostic or imaging performance metric.
4. Adjudication method for the test set
Not applicable. No clinical adjudication method 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 is a laser device, not an AI-assisted diagnostic or imaging device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device (laser).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on adherence to recognized international safety and performance standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2) and a demonstration of substantial equivalence in intended use and technical specifications to previously cleared predicate devices.
8. The sample size for the training set
Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(234 days)
J. MORITA USA, INC.
The Tri Auto mini motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning. When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals.
The Tri Auto mini is an battery-driven handpiece with a motor, equipped with the chuck for holding rotary instrument such as a dental file and a reamer. Tri Auto mini can be used for enlargement and preparation of root canals. When connected to Apex Locator (which is not included in this application), the Tri Auto mini indicates the position of the file tip inside the root canal.
The provided document is a 510(k) summary for the J. Morita USA Inc.'s Tri Auto mini, an endodontic treatment motorized handpiece. It aims to establish substantial equivalence to predicate devices, rather than establishing acceptance criteria for novel device performance and proving those criteria through a study with specific performance metrics.
Therefore, the information requested in your prompt (acceptance criteria, specific study details like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this type of regulatory submission.
Here's why and what information related to performance testing is available:
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Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often done by showing similar indications for use, technological characteristics, and performance. It does not typically involve setting novel performance acceptance criteria and then conducting a new clinical study to meet those criteria as would be expected for a device with a new intended use or technology.
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Performance Testing Mentioned: The document states:
"PERFORMANCE TESTING
The Tri Auto mini was tested in accordance with IEC 60601-1, IEC 60601-1-4, UL 60601-1, CAN/CSA C 22.2 No.601.1-M90, and IEC 60601-1-2. Also, Biocompatibility, sterilization, and software validation were conducted.
Test results shows that Tri Auto mini is substantially equivalent to predicate devices."This indicates that various safety and functional standards were met, and tests related to biocompatibility, sterilization, and software validation were performed. These are standard tests for medical devices to ensure they are safe and perform as intended, but they are not specific performance metrics in the way you've outlined for AI/diagnostic devices (e.g., sensitivity, specificity, accuracy).
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Comparison to Predicate Devices: The "Comparison summary table" clarifies that the "Performance Canal Enlargement Function" of the Tri Auto mini is "Identical" to both predicate devices (Tri Auto ZX and ROOT ZX II). This implies that the performance in its stated function is considered equivalent, rather than needing to meet distinct, quantitative acceptance criteria.
In summary, the provided document does not contain the specific information you requested because it's a 510(k) submission focused on demonstrating substantial equivalence, not a study report establishing novel acceptance criteria and proving them with detailed performance metrics.
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(396 days)
J. MORITA USA, INC.
TORQTECH transmits rotation of the motor to dental burrs and reamers which cut or grind teeth or dentures with the same or transformed rotation.
The TORQTECH device is a dental handpiece to be attached to an electric or air powered dental motor, designed for polishing, grinding, and drilling of teeth/dentures. The device transmits rotational force from the motor to the rotor shaft through a clutch, and the dental burrs or reamers chucked on the shaft are able to polish, grind or cut the teeth/dentures of the patient receiving these rotations. There are two types of the TORQTECH device: one is a "straight" linear model (Model ST-DH) while the other is angled and geared (Models CA-DC, CA-DC-O, and CA-5IF-O). The geared models vary based on angle and rotation due to the gear between the clutch and rotor shaft. An optional headlight is available, fed through the light-guide from the motor portion.
Here's an analysis of the provided text regarding the TORQTECH device's acceptance criteria and the study proving it, structured according to your request:
Acceptance Criteria and Device Performance for TORQTECH Dental Handpiece
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Performance: Conformity to ISO 7785-2:1995 (dental handpieces - Part 2: straight and geared angle handpieces) | Device was developed and tested in accordance with this standard. (No specific performance metrics are provided, but compliance with the standard implies acceptable performance.) |
| Coupling Dimensions: Conformity to ISO 3964 (dental handpieces - coupling dimensions) | Device was developed and tested in accordance with this standard. |
| Risk Management: Conformity to ISO 14971:2007 (medical devices - application of risk management to medical devices) | Device was developed and tested in accordance with this standard. Risk analysis under ISO 14971:2007, combined with biological evaluation, demonstrated the spray's suitability. |
| Biocompatibility (General): Conformity to ISO 10993-1:2003 (biological evaluation of medical devices -- Part 1: evaluation and testing) | Device was developed and tested in accordance with this standard. |
| Biocompatibility (Cytotoxicity): Conformity to ISO 10993-5:2009 (biological evaluation: test for in vitro cytotoxicity) | Device was developed and tested in accordance with this standard. Cytotoxicity test results demonstrated the spray's suitability. |
| Biocompatibility (Sample Prep): Conformity to ISO 10993-12:2007 (biological evaluation: sample preparation and reference materials) | Device was developed and tested in accordance with this standard. |
| Sterilization Information: Conformity to ISO 17664:2004 (information to be provided by the manufacturer for the processing of resterilizable medical devices) | Device was developed and tested in accordance with this standard. |
| Labeling (Graphical Symbols): Conformity to EN 980:2008 (graphical symbols for use in the labeling of medical devices) | Device was developed and tested in accordance with this standard. |
| Labeling (Information Supplied): Conformity to EN 1041:2008 (information supplied by the manufacturer with medical devices) | Device was developed and tested in accordance with this standard. |
| Spray Biocompatibility (Sensitization/Irritation): No sensitization, no irritation. | Results of sensitization and irritation testing under ISO 10993-1 showed the spray to not cause sensitization and that it is not an irritant. |
| Spray Propellants: Safety for clinical use. | The same gases (propane, butane, isobutane) have been cleared for use in the predicate Kavo device (K#012308). |
| Substantial Equivalence: To predicate devices K#080677, K#061701, K#070074, K#012308 in terms of intended use, principle of operation, and technological characteristics. | The information provided demonstrates substantial equivalence based on comparative tables and descriptions, concluding that differences do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not mention a "test set" in the context of a clinical study or a specific dataset used for performance evaluation of the device against a ground truth. The primary method for proving the device meets acceptance criteria appears to be adherence to recognized standards and a substantial equivalence comparison to predicate devices, rather than a direct performance test against a separate "test set" as one might find in software or diagnostic device submissions.
The provenance of data is not applicable in the sense of patient data as no clinical tests were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No "test set" with ground truth established by experts is described in the document. The evaluation relies on compliance with technical standards and comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a dental handpiece, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manual dental instrument, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is primarily established by:
- Compliance with recognized international standards (ISO, EN).
- Demonstrated substantial equivalence to legally marketed predicate devices, implying that if the device is similar in technology, intended use, and performance characteristics to a device already deemed safe and effective, it is also safe and effective.
- Results of specific non-clinical tests (sensitization, irritation, cytotoxicity) against relevant ISO standards.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware dental handpiece, not a machine learning model. Therefore, there is no "training set" in the AI sense.
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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(235 days)
J. MORITA USA, INC.
RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
The provided 510(k) summary for the J. MORITA USA Inc.'s RCM-7 Apex Locator does not contain the detailed information requested regarding acceptance criteria and the specific study that proves the device meets those criteria.
The document focuses on establishing substantial equivalence to previously cleared predicate devices (Root ZX and DP-ZX-VL) by comparing general intended uses, principles of operation, and technological characteristics. It lists various characteristics and whether they are identical or similar to the predicate devices. However, it does not provide:
- Specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision).
- Details of a study designed to demonstrate that the RCM-7 explicitly meets such acceptance criteria.
- Information on sample sizes, data provenance, ground truth establishment, or expert involvement for any performance testing.
Therefore, most of the requested fields cannot be filled based on the provided text.
Here's an analysis of what can be inferred or what is explicitly missing:
Acceptance Criteria and Study for J. MORITA USA Inc.'s RCM-7
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria or performance metrics are provided in the document. | No specific quantitative performance data is provided in the document. |
| General Equivalence | General Equivalence |
| Indication for use (Canal Measurement Function) Identical to predicate devices. | Identical to Root ZX (K921979/K953867) and DP-ZX-VL (K071190). |
| Target population Identical to predicate devices. | Identical to Root ZX (K921979/K953867) and DP-ZX-VL (K071190). |
| Performance (Canal Measurement Function) Identical to predicate devices. | Identical to Root ZX (K921979/K953867) and DP-ZX-VL (K071190). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not provided. The document does not describe a specific test set or study conducted for the RCM-7.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. The document does not mention any expert involvement for establishing ground truth for performance testing of the RCM-7.
4. Adjudication method for the test set
- Not provided. No test set is described.
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. The RCM-7 is an Apex Locator, a standalone dental device for root canal length measurement, not an AI-assisted diagnostic tool that would involve human readers in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is an Apex Locator, which by its nature operates "standalone" in performing its measurement function. However, the document does not describe a specific "standalone performance study" with metrics and results for the RCM-7 itself. Instead, it relies on demonstrating equivalence in performance to predicate devices.
7. The type of ground truth used
- Not explicitly defined for the RCM-7. For an apex locator, ground truth for canal length would typically be established by direct measurement (e.g., manual file measurement to the apex) or highly accurate imaging, but this is not detailed for the RCM-7's submission. The document relies on the established performance of the predicate devices.
8. The sample size for the training set
- Not applicable/Not provided. The RCM-7 is an Apex Locator, likely based on electrical impedance principles, rather than a machine learning or AI-based device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there is no mention of a training set for this type of device.
Summary of Missing Information:
The 510(k) summary for the RCM-7 primarily focuses on demonstrating substantial equivalence to its predicate devices by comparing their specifications and intended uses. It does not include specific clinical or performance study data, acceptance criteria, or details about ground truth establishment that would typically be found in submissions requiring such evidence. For devices demonstrating substantial equivalence through comparison, the detailed performance data for the predicate devices often serves as the benchmark, and new studies are usually not required unless there are significant technological differences that raise new questions of safety or effectiveness.
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(185 days)
J. MORITA USA, INC.
AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system. Attachments are geared handpieces that are used to drill and polish teeth.
This instrument is designed for dental treatment such as grinding, drilling and polishing teeth.
The provided text is a 510(k) summary for a dental handpiece (AIR TORX) and does not contain information about studies proving the device meets specific acceptance criteria as it would for a software AI/ML device.
The document states that the device is classified as a non-exempt Class I device and its substantial equivalence is based on similar general intended uses, principles of operation, and technological characteristics to a predicate device (MICRO AIR MOTOR A-25LT, K944713). It explicitly states that "these differences do not raise new questions of safety or effectiveness," which means that extensive new performance studies (like those requiring acceptance criteria, test sets, or ground truth establishment) are generally not required for Class I devices deemed substantially equivalent through this pathway.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods typically associated with proving the performance of novel medical devices, especially AI/ML-based ones.
Specifically, the following requested information is absent from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The comparison table is for "Technological characteristics" and primarily states "Similar" for most categories.
- Sample size used for the test set and the data provenance: Not applicable/not present. No clinical or performance test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
- Adjudication method for the test set: Not applicable/not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/not present. This device is a mechanical dental handpiece, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
- The type of ground truth used: Not applicable/not present.
- The sample size for the training set: Not applicable/not present.
- How the ground truth for the training set was established: Not applicable/not present.
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