Search Results

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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The General System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordoss), (3) spinal tumor, (4) failed previous fusion, (6) spinal stenosus. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft.

The General Spinal System consists of Fixed-Angle Reduction Screws. Rods, Cross Link and set screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

The provided document is a 510(k) summary for the "General Spinal System," a pedicle screw spinal system. It describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, detailed study designs (such as sample sizes, ground truth establishment, or expert qualifications), or the results of comparative effectiveness studies (MRMC) or standalone algorithm performance studies that would be necessary to answer the questions thoroughly.

Therefore, I can only provide information based on what is available in the document.

Detailed Breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., specific load endurance values, displacement limits) that a device must meet, nor does it report specific numerical performance results for the device against such criteria.

Instead, the document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standard: ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items: Static compression bending test; Dynamic compression bending test; Static torsion test."

This implies that the acceptance criteria are adherence to the ASTM F1717-04 standard's methodologies and achieving comparable performance to the predicate device(s) within the scope of these tests. Without specific data, a table cannot be constructed with numerical values.

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

The document describes non-clinical mechanical tests. It does not involve human data or test sets in the context of clinical trials. Therefore, "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable in the context of this device's testing as described. The testing was likely conducted in a laboratory setting.

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

This question is not applicable as the document describes non-clinical mechanical testing, not a study involving ground truth established by experts (e.g., radiologists, pathologists). The "ground truth" for mechanical testing is typically defined by the test standard (e.g., ASTM F1717-04) and the physical properties observed.

4. Adjudication method for the test set

This question is not applicable for the same reason as points 2 and 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert consensus scenarios, not for mechanical bench testing.

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

This question is not applicable. The device is a "General Spinal System" (a pedicle screw spinal system), which is a physical implant, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to this device.

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

This question is not applicable. The device is a physical medical implant, not an algorithm or software.

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

For the non-clinical tests described, the "ground truth" refers to the established performance characteristics and requirements outlined in the ASTM F1717-04 standard for spinal implant constructs, as well as the observed mechanical properties (e.g., strength, stiffness, fatigue life) of the tested device and its predicate(s). It is purely objective mechanical measurement, not a subjective "truth" established by experts or clinical outcomes.

8. The sample size for the training set

This question is not applicable. The document describes the testing of a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable for the same reason as point 8.

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The Beacon Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The proposed Beacon Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The proposed Beacon Tissue Marker is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. The proposed Beacon Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

The proposed Beacon Tissue Marker is comprised of Oxford Performance Materials (OPM) OXPEKK-IG200 filled with Barium Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.

The delivery system is a sterile, single patient use, pre-loaded delivery system incorporating the Beacon Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, tabs to retain the tissue marker, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The Beacon Tissue Marker delivery system is used to place the Beacon Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a beveled 12 cm / 14 gauge needle with 1 cm depth marks and a plunger.

Here's an analysis of the acceptance criteria and study for the Beacon Tissue Marker, based on the provided 510(k) summary:

Device: Beacon Tissue Marker™ (Implantable Clip)

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not specify the exact sample sizes used for each of the non-clinical tests (e.g., deployment force, marker expulsion, etc.). It only broadly states that "All testing met pre-defined acceptance criteria."

The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given that this is a non-clinical, bench-top testing summary, it would typically be prospective testing conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided in the 510(k) summary. The testing described for this device is non-clinical, engineering-based performance testing (e.g., deployment force, bond strength, dimensions). There is no mention of medical image interpretation or human subject studies that would require experts to establish a "ground truth" for diagnostic or clinical performance.

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 involving human interpretation or subjective assessments, which are not described in the non-clinical testing for this device.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor is it relevant for the type of device and testing described. MRMC studies are used to assess the impact of a medical device (often AI-assisted diagnostic tools) on human reader performance in interpreting medical images or data. The Beacon Tissue Marker is an implantable clip for marking soft tissue, and its performance is evaluated through engineering and biocompatibility testing, not clinical diagnosis or interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

No. A standalone algorithm performance study was not done. This device is a physical implantable marker and does not involve any algorithms or artificial intelligence for its function or evaluation in the context of this 510(k) summary.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical testing consisted of engineering specifications and predefined performance thresholds. For example:

• Deployment force might have a specified range (e.g., 5N-15N).
• Marker retention might be evaluated by ensuring the marker does not prematurely release under specified forces.
• Dimensions would be compared against design specifications.
• Package integrity would be assessed against industry standards for sterility barrier and leak protection.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of non-clinical device testing.

8. Sample Size for the Training Set

This information is not applicable and not provided. Since the device does not involve algorithms or AI, there is no "training set" in the context of machine learning. The testing performed is to validate the physical and functional aspects of the device against engineering requirements.

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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The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The General Spinal System consists of Fixed-Angle Screws, Fix-Angle Reduction Screws, Hooks, Rods, Cross Link and Set Screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications. which are widely used for surgical implants with well known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

This document describes the General Spinal System, a pedicle screw spinal system. The primary method of demonstrating acceptance criteria for this device is through non-clinical testing, specifically mechanical performance testing, and comparison to a legally marketed predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of constructs tested) for each mechanical test performed under ASTM F1717-04. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
• Data Provenance: The tests are non-clinical (laboratory tests) conducted by Tianjin Walkman Biomaterial Co., Ltd. in China. The data provenance is internal testing, not patient data.

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

• This information is not applicable. The "ground truth" for non-clinical performance evaluations of medical devices like spinal systems is typically established by recognized national/international standards (e.g., ASTM, ISO), which define test methodologies, acceptance criteria, and performance limits. These standards are developed and maintained by committees of experts, but specific "experts" assigned to establish "ground truth" for a particular device's test set are not mentioned or required in this context.

4. Adjudication Method for the Test Set

• This information is not applicable. The non-clinical tests involve objective measurements (e.g., load, displacement) against specified performance criteria, rather than subjective interpretation requiring adjudication among multiple parties.

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 performed. This type of study is relevant for diagnostic imaging devices where human interpretation of images is a key factor. This submission pertains to a surgical implant (pedicle screw spinal system), where performance is assessed through mechanical testing and material properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable. The device is a physical surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance in this context is defined by established engineering and material standards. Specifically:
  • Mechanical Integrity: ASTM F1717-04 defines the "ground truth" for appropriate mechanical performance characteristics (static/dynamic bending, torsion) expected of spinal implant constructs.
  • Material Biocompatibility: ASTM F136-02a defines the "ground truth" for the material properties and biocompatibility of the titanium alloy used.
  • Sterilization: ISO 17665-1:2006 defines the "ground truth" for a validated sterilization process to achieve a specified Sterility Assurance Level.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set. The design and manufacturing process are informed by general engineering principles and material science, not a data-driven "training" process in the AI sense.

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

• This information is not applicable as there is no "training set" for this device.

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General Purpose Temperature probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.

Temperature probes are used during patient temperature measurement and consist of a plug connected to a patient monitor and a thermistor on the patient end. The thermistor consists of a resistor which is sensitive to temperature changes. The portfolio includes General Purpose Temperature probes to be inserted into the oesophagus or the rectum and Skin Temperature Probes. The devices are intended for single patient use and can be used with Dräger and Siemens patient monitors.

Here's an analysis of the provided 510(k) summary, aiming to describe the acceptance criteria and the study proving the device meets them, based on the input text:

Acceptance Criteria and Device Performance for Dräger Temperature Probes (K121999)

Based on the provided 510(k) summary (K121999) for Dräger Temperature Probes, the document outlines verification and validation measures, but it does not explicitly state specific numerical acceptance criteria or detail the quantitative results of a study demonstrating these criteria have been met for accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to general performance and safety tests.

The document indicates that the device's performance is within an acceptable range for clinicians, implying that the acceptance criteria for these tests were met, but the specific metrics are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size used for the test set or the country of origin of the data. It mentions "Verification & validation measures include but are not limited to the following key tests," implying these tests were conducted, but offers no details about the testing methodology, sample sizes, or data provenance (retrospective or prospective) for each specific test.

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

The document does not mention the use of experts to establish ground truth for a test set. This type of device (temperature probes) typically relies on metrological standards and comparisons to reference instruments rather than expert opinion for ground truth.

4. Adjudication Method for the Test Set

As there's no mention of expert ground truth establishment, there is no adjudication method described.

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

An MRMC comparative effectiveness study was not performed or is not mentioned in the provided document. This type of study is relevant for diagnostic imaging interpretation devices, not for basic medical instruments like temperature probes.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a physical temperature probe, not an algorithm, so a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable and therefore not mentioned. The probes' performance is evaluated standalone in terms of their physical and electrical properties when connected to a monitor.

7. Type of Ground Truth Used

The ground truth for the verification and validation tests would typically be established by metrological reference standards for temperature measurement, and possibly by laboratory testing against known environmental conditions, for tests like accuracy, electrical safety, mechanical tests, and environmental resistance. For biocompatibility, the ground truth is established by adherence to recognized biocompatibility standards (e.g., ISO 10993). The document confirms that for accuracy, the "function and principle of operation as well as the characteristic of the used NTC (YS1400) are equal" to predicate devices, implying that their inherent accuracy characteristics are comparable using established physical principles.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of this device. Temperature probes are not AI/ML devices that require training sets. Their performance is based on physical design and manufacturing.

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

As there is no training set, this question is not applicable.

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