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SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.

SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.

SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment.

Digital Temp resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.

The provided text is a 510(k) summary for SprintRay Digital Temp, a light-curable resin used for fabricating temporary dental restorations. It does not contain information on acceptance criteria or studies proving that a device meets such criteria for an AI/ML-based medical device.

Instead, it focuses on the substantial equivalence of the Digital Temp resin to a predicate device based on:

1. Intended Use/Indications for Use: Both are for temporary dental restorations.
2. Technological Characteristics: Both are light-cured acrylate resins used with 3D printers and scanned 3D images.
3. Performance Data: Biocompatibility testing and bench testing based on ISO 10477 were performed, and the resin "functioned as intended."

Therefore, I cannot extract the requested information about acceptance criteria and the study proving an AI/ML device's performance, as the document describes a material (resin) and not an AI/ML algorithm.

The questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies) are highly relevant to AI/ML device evaluations but are not addressed in this material-focused 510(k) summary.

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ArthroPlan™ is indicated for use by suitably licensed and qualified healthcare professionals requiring access to medical images to be used in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the size and geometry of the prosthetic/fixation device when planning a potential hip arthroplasty surgical procedure. Templating is done without alteration of the original image, using scaling and measurement tools in a digital environment, in conjunction with manufacturers' templates available via the ArthroPlan library of digital templates for prosthetic and fixation devices.

ArthroPlan™ is software designed and developed for preoperative planning, a.k.a. digital templating, for orthopedic operations. It includes tools for performing common measurements and drawings in combination with orthopedic implant manufacturer's electronic templates (provided in the ArthroPlan Template Library, which is part of the software). The measurements and scaling tools enable the user performing preoperative planning for orthopedic procedures. - The software allows the user to capture the radiographic image, import it to the software, accurately scale the degree of maqnification of the image, and overlay and manipulated (size, angle, rotate, invert, etc.) the desired electronic template(s) on the image facilitating the election of the appropriate size of prosthetic/fixing.

The provided text describes the ArthroPlan Digital Templating Software and its 510(k) submission. However, it does not detail specific acceptance criteria with quantifiable metrics for device performance (e.g., accuracy, precision) or a study report that provides these performance numbers against those criteria.

Instead, the document focuses on:

• Substantial Equivalence: Asserting that the ArthroPlan is as safe and effective as predicate devices with similar intended uses, technological characteristics, and principles of operation.
• Functional Testing: Stating that performance testing showed the software "functioned as intended" and "meets its specifications" for functions like image collection, scaling, templating, and reporting.
• Compliance with Standards: Listing various FDA guidances and ISO/IEC/NEMA standards that the testing complied with.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and detailed study parameters are not present in the provided text.

Here's an attempt to answer based on the available information, noting where information is absent:

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

The document does not explicitly state quantifiable acceptance criteria (e.g., "Accuracy of scaling must be within X%") or report specific performance numbers for the device against such criteria. Instead, it broadly states that the device "functioned as intended" and "meets its specifications."

The "Performance Data" section lists functions that were tested and confirmed:

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 "Performance testing including a non-clinical user validation was conducted on the ArthroPlan software." However, it does not specify the sample size for this test set (e.g., number of images, number of cases). It also does not mention the data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document refers to "a non-clinical user validation" but does not specify the number or qualifications of "users" or "experts" involved in establishing ground truth or validating the software's performance. The "Indications for Use" specifies "suitably licensed and qualified healthcare professionals," but this refers to the intended end-users, not necessarily the validation experts.

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

The document does not describe any adjudication method used for establishing ground truth or evaluating the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating substantial equivalence to predicate devices, not on quantifying human reader improvement with AI assistance. The device is referred to as "software for preoperative planning," and it clearly states "Human Intervention for Interpretation of Images: Requires physician to use and interpret data. Decision on implant selection is up to the physician." This implies it's a tool for assistance, not a standalone diagnostic AI, but no study on its assistive impact is detailed.

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

The document describes the "ArthroPlan™ Digital Templating Software" as a "standalone Microsoft Windows compatible software." The performance testing described (e.g., image collection, scaling, templating) implies testing of the algorithm's functionality in a standalone manner. However, the document also explicitly states, "Requires physician to use and interpret data. Decision on implant selection is up to the physician," indicating it's intended to be used with human-in-the-loop, even if the software itself can operate independently for its defined functions. The testing largely covers the accuracy of its tools (scaling, overlay) rather than diagnostic performance metrics often associated with "standalone" AI.

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

The document does not explicitly state the type of ground truth used. Given the nature of the software (templating and measurement tools), it is highly likely that the ground truth would involve:

• Known physical measurements/standards: For validating the scaling accuracy.
• Manual measurements by experts: For verifying calculations performed by the software.
• Comparison to expert-performed templating: To validate the templating accuracy and functionality against clinically accepted norms, possibly involving comparison to predicate device outputs or expert-derived plans.
  However, this is inferred, not explicitly stated.

8. The sample size for the training set

The document does not mention a training set or any deep learning components that would typically require a training set. The software is described as using "scaling and measurement tools" and "manufacturers' templates," suggesting rule-based or algorithmic functionality rather than a machine learning model that needs a training set.

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

Since no training set is mentioned or implied for a machine learning model, this question is not applicable based on the provided text.

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The iPlan Hip Templating system is indicated for the preoperative planning of orthopedic treatments. It is specially developed for the preparation and display of anatomical patient data that has been acquired using xray, CT or MR equipment.

iPlan Hip Templating creates treatment plans in conjunction with 2D / 3D implant models are provided by a separate database. Both 2D and 3D planning are supported, depending on the anatomical information available.

The treatment plan can either be saved or printed as required.

iPlan Hip Templating is a stand-alone system for preoperative orthopedic treatment planning which facilitates digital template planning for anatomical images. Once image scaling has been completed, using an object of known size that is positioned next to the anatomical area of interest during image acquisition, the surgeons can use a range of measurement tools in order to select the optimum implant for the patient. The software overlays 2D / 3D implant models onto the image data and displays the result. The measurement tools can also be used to display preplanned and current values where required.

The digital implant models are provided by a separate implant database. Both 2D implant contours and 3D implant models are available.

Treatment plans can be saved and printed out as required. The information stored in the treatment plan can be loaded to other BrainLAB applications and used to support image guided surgery in a VectorVision system, for example.

Here's an analysis of the provided text regarding the iPlan® Hip Templating device, focusing on acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria (e.g., target accuracy percentages, precision thresholds) or detailed reported device performance in a quantitative manner.

Instead, the document makes a general statement:

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

The document does not provide any specific information regarding:

• The sample size used for any test set.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

The document does not provide any information regarding:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for a test set.

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

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size of human improvement with AI vs. without AI assistance can be determined from this text.

6. Standalone (Algorithm Only) Performance Study

The document mentions that "iPlan Hip Templating is a stand-alone system for preoperative orthopedic treatment planning," implying its intended use as an algorithm-only tool for planning. However, it does not describe a specific standalone performance study in terms of metrics. The phrase "The validation proves the safety and effectiveness of the system" is a general statement about the system as a whole, not a detailed report of standalone algorithmic performance.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any validation or testing.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set.

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

The document does not provide any information regarding how the ground truth for the training set was established.

Summary of Findings:

The provided document (K042543 510(k) Summary) is a high-level regulatory submission focusing on demonstrating substantial equivalence to a predicate device (iPlan!®2 K020631). It asserts that the validation process (per BrainLAB's procedures) proves the safety and effectiveness of the system. However, it lacks the detailed technical information and study results typically found in reports specifically designed to describe acceptance criteria and evidence of meeting them. This type of information is often contained in the full 510(k) submission, which is not fully provided here. The summary focuses on the intended use, device description, and the FDA's concurrence with substantial equivalence rather than granular performance metrics and study details.

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The Digital temperature monitor, model GT-202, GT-204, and GT-205 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for the measurement of oral, armpit and rectal temperature of all ages.

The Digital temperature monitor, model GT-202/GT-204/GT-205, are the electronic thermometers by using a the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view. the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital Temperature Monitor, models GT-202, GT-204, GT-205:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states that the device was designed and verified according to the US standard ASTM E1112-98. As the document does not provide specific numerical acceptance criteria from ASTM E1112-98 or detailed performance results, the table below reflects what is stated in the document.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device was "designed and verified according to the US standard ASTM E1112-98" and that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be related to engineering verification against a standard rather than clinical expert evaluation for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. The validation appears to be against a technical standard (ASTM E1112-98) rather than an expert-adjudicated clinical dataset.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a standalone temperature monitor, and the evaluation focuses on its technical performance against a standard, not on assisting human interpretation.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done. The document states: "Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98." This indicates that the device's accuracy and performance were evaluated according to this standard.

7. Type of Ground Truth Used

The ground truth used for the standalone performance study was based on the standards and specifications outlined in ASTM E1112-98. This standard would define the acceptable accuracy limits and test methodologies for digital clinical thermometers. It's an engineering and performance standard rather than a clinical ground truth like pathology or expert consensus on a medical image.

8. Sample Size for the Training Set

The document does not mention any training set size. This device (a digital thermometer) is a hard-wired control system (ASIC-controlled circuit) rather than a software-based AI system that would typically require a training set. The performance is determined by its hardware design and implementation to meet specific accuracy standards.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set, there is no information on how its ground truth was established. This type of device does not involve machine learning or AI that would typically use a training set with established ground truth.

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The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.

The Digital temperature monitor, model KY-01, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low. the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98.

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to compliance with ASTM E1112-98 as the primary standard for performance verification. This standard is for electronic thermometers. Therefore, the acceptance criteria are derived from this standard. The document doesn't explicitly state all performance metrics or their specific values from the standard, but it asserts compliance.

Study Proving Device Meets Acceptance Criteria:

The document states: "Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98." And also, "Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement."

This indicates that the device underwent non-clinical testing to demonstrate compliance with these standards. The specific details of these tests (e.g., number of measurements, specific temperature points tested) are not provided in this summary.

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

The document does not specify the sample size used for the test set or any details about human subjects. The testing described is "non-clinical tests" and compliance with standards, which would typically involve laboratory measurements on the device itself, potentially using simulated body temperatures or calibrated constant temperature baths. Given the nature of a digital thermometer, a "test set" in the context of patient data (prospective or retrospective) is not the primary means of demonstrating compliance with performance standards like ASTM E1112.

The data provenance is not applicable in the human subject data sense, as the performance evaluation referenced appears to be engineering and laboratory-based. The device's manufacturer is Kang Ying Medical Appliances Inc. in Taiwan.

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

This question is not applicable in the traditional sense of clinical imaging or diagnostic device ground truth. The "ground truth" for a thermometer's accuracy would be established by reference to highly accurate, calibrated temperature standards in a laboratory setting, not by human experts. The involved "experts" would be metrology engineers or technicians. The document does not specify their number or qualifications.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation described is laboratory-based compliance testing against a standard, not expert adjudication of a diagnostic finding.

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 is not applicable. The device is a digital thermometer, not an AI-assisted diagnostic tool.

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

The device itself is a standalone electronic thermometer. Its performance, as measured by compliance with ASTM E1112-98, would be its "standalone" performance. The document doesn't describe separate "algorithm only" performance, as the device's functionality is directly tied to its physical components (thermistor, ASIC).

7. The Type of Ground Truth Used

The ground truth used for assessing the thermometer's performance would be:

• Calibrated Reference Temperatures: Highly accurate and traceable temperature standards (e.g., from a national metrology institute) used in a laboratory setting to verify the accuracy of the thermometer's readings.
• Compliance with ASTM E1112-98: This standard itself defines the acceptable deviations from true temperature for different temperature ranges, acting as the ground truth for performance.

8. The Sample Size for the Training Set

This is not applicable. The device is a digital thermometer that uses a thermistor and an ASIC for calculation. It is not an AI/machine learning device that requires a "training set" of data in the computational sense. Its "training" is in its design and calibration processes.

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

This is not applicable for the same reasons as point 8.

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