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X65L / X65 / M65

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations.

FX65 / FX65m / EX-5B

General Cutting Straight is intended for the following application(s):

Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.

The General Cutting Straight is a prescription-only dental straight handpiece used by qualified dental healthcare professionals in general dentistry. The General Cutting Straight includes six models: X65L, X65, M65, FX65m, FX65, and EX-5B. The General Cutting Straight conforms to ISO 14457 and is driven by an ISO 3964-compliant electric or air motor. The General Cutting Straight achieves its intended use in conjunction with an ISO 1797-compliant rotary instrument or a prophy angle that conforms to either ANSI ADA Standard No. 85-2004 (R2009) or ISO 14457. The General Cutting Straight is composed mainly of stainless steel, titanium, or aluminum, depending on the model, and is reusable, requiring cleaning and steam sterilization. The accessories of the General Cutting Straight include the Bur Stopper, Bur Stopper Puller, and E-Type Spray Nozzle. The General Cutting Straight is lubricated with the PANA SPRAY Plus [K163486] using the E-Type Spray Nozzle.

This document describes the 510(k) summary for the "General Cutting Straight" dental handpiece. It details its intended use, technological characteristics, and comparison to a predicate device. However, this document does not contain information about a study proving the device meets specific performance acceptance criteria beyond general statements that it met applicable tests from ISO 14457:2017.

The device in question, "General Cutting Straight," is a dental handpiece, which is a mechanical device. The clearance is based on substantial equivalence to a predicate device, not on clinical performance data from an AI or imaging-based diagnostic system. Therefore, the specific questions related to AI/imaging device performance (e.g., sample sizes for test and training sets, expert consensus, MRMC studies, ground truth establishment) are not applicable to this submission type.

Here’s a breakdown of why many of your specific requests cannot be fulfilled from the provided document:

• Type of Device: This is a Class I basic mechanical dental instrument (a handpiece), not an AI/imaging diagnostic device. Substantial equivalence for such devices typically relies heavily on non-clinical performance testing (e.g., safety, mechanical function, biocompatibility) and comparison of specifications to a legally marketed predicate, rather than human-in-the-loop clinical efficacy studies with ground truth derived from expert consensus on images.
• Regulatory Pathway: This is a 510(k) submission for a Class I device. Clinical data is often not required for Class I devices, especially when substantial equivalence can be demonstrated through non-clinical means. The document explicitly states: "Clinical testing was not required as the differences from the predicate device are minor and non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the General Cutting Straight."

Given the nature of the device and the provided document, here's what can be extracted and why other questions are not applicable:

Acceptance Criteria and Device Performance (as far as provided for this mechanical device type):

The document states that NAKANISHI INC. conducted performance testing in accordance with ISO 14457:2017 "Dentistry - Handpieces and motors" and that "All acceptance criteria for the applicable tests were met."

However, the specific quantitative acceptance criteria and the numerical results of the "reported device performance" are not detailed in this summary. The summary only provides qualitative confirmation of compliance with the standard.

Answers to Specific Questions in the Context of this Mechanical Device 510(k):

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

   • As shown above, the document states general compliance with ISO standards (ISO 14457:2017 for performance, ISO 10993-1:2018 for biocompatibility, ISO 17665-1:2006 for reprocessing). Specific quantitative acceptance criteria or numerical performance data are not provided in this 510(k) summary. The "acceptance criteria" listed are the qualitative statements of meeting the standards.

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

   • Not Applicable. This is a mechanical device, not an AI/imaging diagnostic device that uses "test sets" of patient data in the way you are implying for AI algorithm validation. Performance testing was likely conducted on a sample of manufactured devices, but the size and specifics are not provided in this summary. Data provenance (country of origin of data, retrospective/prospective) is not relevant for this type of mechanical device testing.

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

   • Not Applicable. Ground truth in the context of expert review of images is not relevant for a mechanical dental handpiece. The "ground truth" for this device is its mechanical functionality, safety (biocompatibility), and ability to be reprocessed, which are assessed through engineering and laboratory tests, not human image interpretation.

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

   • Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in imaging studies. This is not applicable to the performance testing of a mechanical dental handpiece.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This is a mechanical device, not an AI-assisted diagnostic tool. MRMC studies are designed for evaluating diagnostic AI systems in conjunction with human readers.

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

   • Not Applicable. This is a mechanical device; there is no "algorithm" to be evaluated in a standalone manner.

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

   • For this mechanical device, "ground truth" pertains to its engineering specifications, material properties, and functionality under test conditions. This is established through laboratory testing against predefined engineering and biocompatibility standards, not through expert consensus on clinical images or pathology findings.

8. The sample size for the training set:

   • Not Applicable. This is a mechanical device; there is no "training set" in the context of machine learning or AI.

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

   • Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not pertinent.

In summary, the provided document is a 510(k) clearance letter and summary for a basic mechanical dental handpiece. It confirms compliance with relevant mechanical and biocompatibility standards but does not detail the specific quantitative results of the performance tests or involve the types of studies (e.g., clinical imaging trials, AI algorithm validation) that would address most of your specific questions.

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The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic applications.

This device consists of X-ray control, high-voltage generator, X-ray tube support, irradiation equipment, detectors, patient photography stand, digital imaging device, viewer SW, etc. The detectors and the viewer SW are cleared under the following 510ks.

• VIVIX-S VW(K200418) . Model Names: FXRD-2530VW, FXRD-2530VW PLUS, FXRD-3643VW, FXRD-3643VW PLUS, FXRD-4343VW, FXRD-4343VW PLUS, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively.
  A high frequency inverter (Inverter) X-sensor voltage device designed to generate X-rays by combination of tube voltage, tube current, irradiation time, etc. so that it can be filmed at various angles for diagnosis of the patient's skeletal, respiratory, and urinary systems. The digital imaging system is used to obtain the images taken by the X-ray unit as radiation from the X-ray unit passes through the human body and is transmitted by the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software, VXvue, acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors.

The provided text describes a 510(k) premarket notification for the GR10X Digital X-ray Imaging System (Models GR10X-40K, GR10X-50K). The submission aims to demonstrate substantial equivalence to a predicate device (Ysio, K081722).

Based on the document, here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a quantitative format for the clinical study. Instead, the "acceptance criteria" for the clinical study is an overarching statement that the device "provides images of equivalent diagnostic capability to the predicate devices."

The reported device performance from the clinical study is:

• "the study confirmed that the GR10X Digital X-ray Imaging System provides images of equivalent diagnostic capability to the predicate devices, the Yiso and its results demonstrate substantial equivalence."

For non-clinical performance (technical specifications), here's a table comparing the subject device's detectors (VIVIX-S VW Series, VIVIX-S 1717V) to the predicate's detector (Trixell Pixium 4343RCE):

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

The document mentions a "single-blinded concurrence study" as a "clinical test" but does not provide any specific quantitative details regarding the sample size of the test set, or the provenance (country of origin, retrospective/prospective nature) of the data used in this clinical study.

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)

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. It only refers to a "single-blinded concurrence study."

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

The document states "a single-blinded concurrence study was conducted." It does not provide details on the specific adjudication method used (e.g., 2+1, 3+1, or if it was based on individual expert assessment without formal adjudication). The term "concurrence" implies agreement among readings, but the method for achieving or resolving discrepancies is not 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

The document describes a "single-blinded concurrence study" comparing the GR10X system to predicate devices. This study aims to confirm "equivalent diagnostic capability." It is not explicitly described as a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving AI assistance for human readers. The device is an X-ray imaging system, not an AI-powered diagnostic aid for human readers. Therefore, no effect size of human readers improving with AI vs without AI assistance is reported or relevant based on the information provided.

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

This refers to an X-ray imaging system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in the context of this device's evaluation. The evaluation is focused on the image quality and diagnostic capability of the imaging system itself.

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

The document mentions a "single-blinded concurrence study" to confirm "equivalent diagnostic capability." While this implies expert interpretation, it does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The phrase "concurrence study" suggests that the comparison was based on human expert interpretations of images from both the subject and predicate devices.

8. The sample size for the training set

The document describes a clinical study for product clearance and does not mention any "training set." This type of submission (510k for a general X-ray system) typically involves demonstrating performance against a predicate device, and not machine learning model training. Therefore, there is no information on a training set sample size.

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

As there is no mention of a "training set" in the context of a machine learning model, this question is not applicable based on the provided text.

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The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-CS01 is a series of solid-state x-ray detectors. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the digital values are sent to the PC via wired or wireless connection, converted to images with the CXDI Control Software (CCS), then displayed on monitors. The digital value can be communicated to the operator console via wired or wireless connection.

The subject of this Special 510(k) submission is a change to the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless to make a series of detectors including the DIGITAL RADIOGRAPHY CXDI-702C Wireless (K192632), CXDI-402C Wireless (K192632), CXDI-710C Wireless (K170332), CXDI-810C Wireless (K170332), and CXDI-410C Wireless (K171270), under the proposed device the DIGITAL RADIOGRAPHY CXDI-CS01. This change will change the Multi Box to be a Standard Component from an optional component for the detectors. The Multi Box has the functions of connecting to the X-ray generator to synchronize the X-ray exposure and photographing, supplying power to the FPD (front panel detector), communicating between the FPD and the image capture computer, connecting the status indicator to the Multi Box to turn the FPD on and off and switch to a ready state, connecting to the WLAN access point to communicate to the FPD wirelessly, and connecting to the docking station to charge the FPD and communicate between the FPD and image capture computer. These functions of the Multi Box have not changed since its clearance under the predicate device (K192632). The X-ray I/F (Interface) Unit has been removed as an optional component for the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless as the Multi Box performs the function of the X-ray I/F Unit (connecting to the X-ray generator to synchronize the x-ray exposure and photographing). In addition, the detectors will all use the version software cleared under the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless (K192632). Together, these changes make up the DIGITAL RADIOGRAPHY CXDI-CS01.

The provided text describes a Special 510(k) submission (K203849) for a device called "DIGITAL RADIOGRAPHY CXDI-CS01". This submission is for modifications to previously cleared devices rather than a new standalone device. Therefore, the document focuses on demonstrating that the changes do not negatively impact the device's compliance with established standards and do not raise new questions of safety or effectiveness compared to the predicate device.

The acceptance criteria are therefore related to maintaining compliance with existing performance standards and regulations rather than establishing new performance metrics. The study described is a verification/validation activity to confirm that the modifications do not affect compliance.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific quantitative acceptance criteria or performance metrics for the device's diagnostic capabilities (e.g., sensitivity, specificity for detecting a disease). Instead, it focuses on demonstrating continued compliance with established standards after modifications. The "performance" section primarily shows that key technical characteristics related to image acquisition are identical to the predicate and reference devices.

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

The document does not specify a "test set" in terms of imaging data or patient cases. The study described is a design verification and validation process focused on the engineering and regulatory impact of changes (making the Multi Box a standard component, removing the X-ray I/F Interface as an option, and updating software). This typically involves testing the modified device against specified technical requirements and standards, not a clinical study with a patient image dataset.

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

Not applicable. As described above, this was not a clinical study involving image interpretation with expert ground truth.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed or described. The device is a digital radiography detector and associated software, 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 is not an algorithm for autonomous interpretation. It's an imaging capture device.

7. The type of ground truth used

Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for this submission is adherence to existing regulatory requirements and technical standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device requiring a training set.

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

Not applicable.

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The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.

The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows: Z95L 1:5 Increasing, Z85L 1:5 Increasing, Z25L 1:1 Direct Drive, Z15L 4:1 Reducing, Z10L 16:1 Reducing. The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area. The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019. The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece. The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.

The provided document is a 510(k) premarket notification for a dental handpiece. It describes modifications to an existing device and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain the detailed information necessary to answer all parts of your request, which primarily focuses on clinical study data, acceptance criteria related to performance metrics, and human-in-the-loop assessments for AI/ML devices.

This document is for a Class I dental handpiece, which is a physical mechanical device, not an AI/ML powered device that would typically involve acceptance criteria like accuracy, sensitivity, specificity, or studies with expert adjudications and MRMC designs.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted (and interpreted for context):

The document primarily focuses on demonstrating substantial equivalence for a modified physical medical device (a dental handpiece) to a previously cleared predicate device. For such devices, acceptance criteria often revolve around engineering performance, material compatibility, and safety standards rather than clinical performance metrics like those for AI/ML.

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

The document mentions "applicable technical standards, internal specifications, and FDA guidance documents" were used. It also states:

What cannot be answered from the provided text:

The following points are typically relevant to AI/ML or diagnostic devices that rely on data for performance metrics (e.g., sensitivity, specificity, AUC). Since this document is for a physical dental handpiece, these concepts don't directly apply in the way you've framed them.

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for a mechanical device would involve engineering tests (e.g., torque, speed, durability, material testing) rather than a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" in the clinical data sense for a mechanical device's direct performance. Adherence to engineering specifications and safety standards are the benchmarks.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML algorithm. For this device, the "ground truth" for performance would be established engineering specifications, material standards, and safety requirements.
8. The sample size for the training set: Not applicable. There is no "training set" for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

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The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.

The General Cutting Contra Handpiece features an allowable maximum motor speed at 40,000 min-1 . The handpieces are provided optic and non-optic and are designed with a contra-angle appearance. Models are available to be connected directly onto motors compliant to ISO 3964. Available handpieces include the S-Max M Contra Series, Ti-Max X Contra Series, Ti-Max Z Contra Series and the Ti-Max nano Series.

The provided text describes a dental handpiece and does not contain information about an AI/ML device. Therefore, I cannot extract acceptance criteria or study details relevant to an AI/ML device from this document.

The document discusses:

• Device Name: General Cutting Contra Handpiece (a dental instrument)
• Manufacturer: NAKANISHI INC.
• Intended Use: Cutting and grinding teeth, cavity preparations, etc., in general dentistry.
• Regulatory Classification: Class I
• Bench Testing: Conformance to technical standards, internal specifications, and FDA guidance documents related to dental handpieces (e.g., sterilization, biocompatibility, electrical safety).
• Substantial Equivalence: Claimed based on similarities to predicate dental handpieces in intended use, operation principles, design, and medical use.

Since this is not an AI/ML device, the requested information regarding AI/ML-specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML does not apply to this document.

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Manually operated minimally invasive General & Plastic Surgery Instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.

Sontec Instruments are a family of manual, instruments consisting of Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors and Suction Tips. These reusable devices are packaged non-sterile and are steam sterilizable.

This document is a 510(k) premarket notification from the FDA, which determines substantial equivalence for medical devices. It does not contain information about the acceptance criteria or a study proving device performance in the way requested for an AI/CADe device.

The requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training data) is typically found in performance studies for diagnostic or AI/CADe devices, which this document is not describing.

This 510(k) document is for "General & Plastic Surgery Instruments," which are manual surgical tools like clamps, forceps, and scissors. The substantial equivalence is based on their intended use, design, material, chemical composition, and energy source compared to existing predicate devices.

Therefore, I cannot provide the requested table and study information because this document does not pertain to an AI/CADe device or a study demonstrating diagnostic performance.

Instead, the document focuses on:

• Device Description: Manual, reusable surgical instruments (Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors, Suction Tips).
• Indications for Use: Performing specific functions (aspirating, clamping, cutting, dissecting, draining, grasping, ligating, probing, or suturing) during open, mini-open, or endoscopic surgical procedures.
• Technological Characteristics: Materials used (Stainless Steel, Titanium, Aluminum 5052, Tungsten Carbide G4) and their conformance to ISO/ASTM standards; cleaning and sterilization procedures (ASTM A380, ASTM F1744, ANSI/AAMI ST79).
• Non-clinical tests: Cleaning, Thermal Disinfection and Steam Sterilization Validations.
• Clinical tests: None (as explicitly stated).
• Substantial Equivalence: Concluded based on intended use, design, material, chemical composition, and energy source being similar to predicate devices, and not introducing new issues of safety or effectiveness.

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