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The Nuance Audio Hearing Aid Software is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The software utilizes a preset fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.

The Nuance Audio Hearing Aid Software is a software-only device that is comprised of a pair of software modules which operate on two separate required products: (1) Nuance Audio Application on a compatible iOS or Android product, and (2) Nuance Audio Hearing Aid Software Firmware (FW) using the compatible wearable electronic computing platform, the Nuance Audio Glasses (smart glasses). The Nuance Audio Hearing Aid Software amplifies sounds for adult users, 18 years of age and older, who have a perceived mild to moderate hearing loss. The Nuance Audio™ App, iOS or Android mobile application, quides the user through the initial onboarding and set up process providing step-by-step instructions to guide the users can select from four preset options, which are generated from typical mild to moderate hearing loss configurations (Urbanski et al., 2021) with NAL-NL2 gain settings applied. The user may also adjust the overall volume, noise reduction, and microphone directionality. The device incorporates a feedback control algorithm to reduce the likelihood of the user experiencing acoustic feedback. The same amplification settings will be applied to both the left and right ear. This device can be fitted by a user without assistance from a hearing healthcare professional.

Here's a breakdown of the acceptance criteria and study information for the Nuance Audio Hearing Aid Software, based on the provided text:

Nuance Audio Hearing Aid Software: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

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

• Usability Testing:
  • Sample Size: 15 representative adult users.
  • Data Provenance: Not explicitly stated, but implies prospective data collection from participants in a usability validation study.
• Real-ear measurements:
  • Sample Size: 29 participant ears.
  • Data Provenance: Not explicitly stated, but implies prospective data collection from participants.
• Speech in noise clinical performance:
  • Sample Size: 19 adults with mild to moderate hearing loss.
  • Data Provenance: Not explicitly stated, but implies prospective data collection from participants.
• Patient Reported Outcome Measure (IOI-HA):
  • Sample Size: 23 adult subjects identified with self-perceived mild-to-moderate sensorineural hearing loss.
  • Data Provenance: Not explicitly stated, but implies prospective data collection after a 14-day trial.

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

The document does not explicitly mention the use of experts to establish ground truth for the test set from these clinical studies. Instead, the studies compare the device's performance against:

• Objective measures: NAL-NL2 targets (a commonly used clinical fitting formula).
• Standardized clinical outcomes: SNR-50 (speech-in-noise ratio) and IOI-HA scores (patient-reported outcome).
• Usability standards: IEC 62366-1:2015.

The ground truth for the "typical mild to moderate hearing loss configurations" used to generate the presets (Urbanski et al., 2021) suggests a reliance on established audiological research rather than individual expert consensus for a specific test set.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned for any of the test sets. The studies appear to rely on direct measurements, standardized clinical tests, or user feedback.

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

No MRMC comparative effectiveness study is reported in relation to human readers improving with AI vs. without AI assistance. The device is a "hearing aid software" rather than an interpretative AI for medical imaging, for example, where MRMC studies are common. The clinical performance studies directly evaluate the device's efficacy.

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

Yes, the studies described for "Performance Testing" (Electro-Acoustics, Real-ear measurements, Speech in Noise, IOI-HA) represent standalone performance of the algorithm integrated into the compatible hardware (Nuance Audio Glasses) without human-in-the-loop clinical decision-making. The usability testing assesses the user's ability to operate the device effectively, which is human-in-the-loop operation, but the core performance metrics are evaluating the device's output.

7. Type of Ground Truth Used for the Test Set

The ground truth for the test sets consisted of:

• Objective Audiological Targets: NAL-NL2 (National Acoustics Laboratories-Non-Linear 2) fitting formula.
• Standardized Clinical Metrics: SNR-50 (signal-to-noise ratio at 50% word recognition) and International Outcome Inventory for Hearing Aids (IOI-HA) scores.
• Usability Standards: Compliance with IEC 62366:2015 and completion of tasks without critical errors.
• Bench Test Standards: Adherence to ISO, ANSI/ASA, CTA, IEC standards for biocompatibility, electrical safety, EMC, battery safety, and software.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. The device uses "four preset options, which are generated from typical mild to moderate hearing loss configurations (Urbanski et al., 2021) with NAL-NL2 gain settings applied." This suggests that the "training" or development of these presets was based on established audiological research and fitting formulas, rather than a data-driven machine learning training set in the typical sense.

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

The ground truth for the "training" (i.e., the generation of the preset fitting strategies) for the Nuance Audio Hearing Aid Software was established based on:

• Published Audiological Research: "Typical mild to moderate hearing loss configurations (Urbanski et al., 2021)."
• Standardized Fitting Formula: Application of the NAL-NL2 (National Acoustics Laboratories-Non-Linear 2) gain settings to these configurations.

This indicates that the presets are derived from established audiological science and validated hearing loss profiles, rather than being "learned" from a distinct training dataset with a separate ground truth determination process.

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1. Direct restorations of anterior or posterior teeth (Class I - Class V)
2. Diastema closures
3. Intraoral repairs of fractured crowns/bridges

nuance® UNIVERSAL is a Class II medical device, under Classification 21 CFR 872.3690. Product Code EBF. intended to be used as a composite tooth restorative. The device falls within the scope of guidance document, "Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions. According to the applicable FDA recognized consensus standard, ISO 4049 - "Dentistry - Polymer-based restorative materials, this device is classified as Class 2: materials whose setting is affected by the application of energy from an external source, such as blue light or heat (Group 2). nuance® UNIVERSAL is used in direct restorations of anterior or posterior teeth. They are polymerizable dental monomer resins that are chemically-cured when exposed to dental curing lights. It is used to form a durable, aesthetic restoration. It is a higher viscosity material to be used where mechanical strength is a primary importance. nuance® UNIVERSAL may be appropriate for dental Class I, II, III, IV and V type restorations. nuance® UNIVERSAL is packaged in a 4 gram single-barrel syringe, a 0.35 gram singules, and offered in 11 shades listed below:

This document details the 510(k) submission for Nuance UNIVERSAL, a light-curable dental restorative material. The submission aims to prove substantial equivalence to a predicate device, CLEARFIL MAJESTY Posterior, rather than establishing acceptance criteria and proving performance through a clinical study as would be done for novel or high-risk devices.

Therefore, many of the requested details, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission, which relies on bench testing against recognized standards and comparison to a legally marketed predicate device with a history of safe use.

Here's the information that is available based on the provided text, structured as closely as possible to your request, with explicit notes for inapplicable sections:

Device: Nuance UNIVERSAL (Light-Curable Dental Restorative Material)

Study Focus: Substantial Equivalence to Predicate Device (CLEARFIL MAJESTY Posterior)

Type of Study Conducted: Bench Testing against ISO 4049 (Dental - Polymer-based restorative materials) and biocompatibility testing. This is not a clinical study involving human patients or an AI/algorithm-based device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO 4049 standard, and the reported performance is compared against these and the predicate device.

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

• Sample Size for Test Set: Not explicitly stated in terms of the number of samples for each test (e.g., how many specimens for flexural strength). The testing was conducted according to the ISO 4049 standard, which specifies the number of samples required for each test. This is bench testing, not a clinical test set from patient data.
• Data Provenance: The data comes from in vitro (bench) testing performed by the manufacturer, Den-Mat Holdings, LLC. The location of the testing facility is not specified, but the company is based in Lompoc, California, USA. The data is prospective in the sense that the tests were performed to generate data for this submission.

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

• Not Applicable. This device is a material, and its performance is evaluated through physical and chemical property testing against an international standard (ISO 4049) and comparison to a predicate device. Ground truth is established by objective measurements based on the standard, not expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing involves objective measurements, not subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

• No. This is not an AI/imaging device requiring an MRMC study. It is a dental restorative material.

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

• Not Applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used

• Objective measurement against an international standard (ISO 4049) and comparative data to a legally marketed predicate device.
• Additionally, Biocompatibility was demonstrated through:
  • Substantial equivalence to the predicate device, citing materials with a long history of safe use in dentistry.
  • Specific in vitro cytotoxicity testing (ISO 10993 Part 5), with the conclusion "the test article was not considered to have a cytotoxic effect (no reactivity)."

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device that requires a training set. The device formulation is based on established dental material science principles and minor modifications to an existing predicate device.

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

• Not Applicable. See point 8.

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Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement.

The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).

The provided text is a 510(k) Summary for the Exodus Drainage Catheters. This document details the substantial equivalence of new drainage catheters to previously marketed predicate devices. It focuses on device description, intended use, technological characteristics, and performance data to demonstrate safety and effectiveness.

However, it does not include the type of study that would typically generate acceptance criteria and performance metrics for a diagnostic AI device. The document describes physical and chemical performance tests for a physical medical device (catheter), not a digital or AI-based diagnostic tool.

Therefore, I cannot fulfill your request for specific acceptance criteria and study details related to an AI device's performance based on the provided text. The information required (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not available in this type of FDA submission for a catheter.

Here's how I would describe the current information, acknowledging its limitations for an AI device:

Based on the provided K152069 510(k) Summary for the Exodus Drainage Catheters, the device is a physical medical device (catheter), not an AI-based diagnostic tool. Therefore, the information requested regarding acceptance criteria and study details for an AI device's performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not applicable or available in this document.

The document details performance testing for the physical attributes and biological compatibility of the catheter.

1. Table of Acceptance Criteria and Reported Device Performance (for a physical catheter):

The 510(k) summary lists the types of performance tests conducted for the Exodus Drainage Catheters to demonstrate substantial equivalence to a predicate device (K093392). While specific quantitative acceptance criteria and detailed reported performance values are not explicitly stated in this high-level summary, the document indicates that the results "demonstrate safety and effectiveness of the proposed device and substantial equivalence."

2. Sample size used for the test set and the data provenance: Not applicable. This summary describes physical testing of devices, not a study involving a "test set" of patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for patient images/data is not relevant to the physical and biological testing of a catheter.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving reader adjudication of diagnostic output.

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 document pertains to a physical medical device (catheter) and does not describe an AI system's performance or human-AI interaction.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device and testing. The "ground truth" for catheter performance relates to established engineering standards, material specifications, and biological safety standards (e.g., ISO 10993-1).

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

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nuance® FLOW is intended to be used as a composite tooth restorative.

nuance® FLOW is recommended for the following types of applications:

1. Direct restorations of anterior or posterior teeth
2. Cavity base/liner
3. Intraoral repairs of fracture crowns/bridges

nuance® FLOW is a Class II medical device intended to be used as a composite tooth restorative. According to the applicable FDA recognized consensus standard, ISO 4049-"Dentistry- Polymer-based restorative materials", this device is classified as Class 2: materials whose setting is affected by the application of energy from an external source, such as blue light or heat (Group 2). nuance® FLOW is DenMat's Flowable for use in direct restorations of anterior or posterior teeth. They are polymerizable dental monomer resins that are chemically-cured when exposed to dental curing lights. It is used to form a durable, esthetic restoration. It is a lower viscosity material that allows it to be used when ease of application and thinner layers are needed. nuance® Flow may be appropriate for dental Class I, III, IV and V type restorations where maximum mechanical strength and wear resistance is not required. A small amount of fluoride (.5-.7%) is included to minimize likelihood of secondary caries. nuance® FLOW is packaged in a 1 mL single• barrel syringe and offered in 8 shades: A1, A2, A3, A3.5, B1, B2, BL1 and BL2.

This document describes the 510(k) premarket notification for the nuance® FLOW dental restorative material, and its substantial equivalence to the predicate device LC FLOWFILL.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test performed on nuance® FLOW or LC FLOWFILL. It only states that "Testing results indicate that nuance® FLOW was as effective and performs as good as the predicate device."

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given that it's a 510(k) submission to the FDA, it is expected that the tests were conducted according to recognized international standards (ISO 4049) which implies controlled laboratory settings. The document also mentions "Scientific literature have been evaluated to support the use of similar products for the same indications," suggesting some reliance on existing published data.

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

This information is not provided in the document. The tests are bench tests based on an international standard (ISO 4049), not clinical evaluations requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set

This information is not applicable as the tests are objective, quantitative measurements against a standard, not subjective interpretations requiring adjudication.

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

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a dental restorative material, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is a physical dental material and not an algorithm.

7. The type of ground truth used

The ground truth used for performance evaluation is based on the objective measurement criteria defined in the ISO 4049 standard for "Dentistry – Polymer-based restorative materials." This standard sets specific quantitative thresholds for various material properties.

8. The sample size for the training set

This information is not applicable as the device is a chemical material, not a machine learning algorithm that requires a training set.

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

This question is not applicable as the device is a chemical material, not a machine learning algorithm.

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1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

The Nuance Freeze Spray System is used in the practice of dermatology in the treatment of skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions.

This 510(k) summary for the Nuance Freeze Spray System does not contain a study that proves the device meets specific acceptance criteria in the way a traditional clinical study with defined endpoints and statistical analysis would. Instead, the submission relies on the concept of substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested elements regarding acceptance criteria and study design are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not define specific acceptance criteria (e.g., a specific percentage reduction in lesion size, a cure rate, or a predefined safety profile) nor does it report performance metrics from a dedicated study against such criteria for the Nuance Freeze Spray System itself. The device's "performance" is implicitly assumed to be equivalent to the predicate devices.

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

Not applicable. There was no specific test set or clinical study conducted for the Nuance Freeze Spray System described in this document. The device relies on comparing its characteristics to predicate devices that have already demonstrated safety and effectiveness through their past clearances.

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

Not applicable, as no dedicated test set or ground truth establishment process is described for this specific submission. The established practices and efficacy of cryogen spray for dermatological conditions, as supported by the predicate devices, serve as the foundational "ground truth."

4. Adjudication Method for the Test Set

Not applicable, as no test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (cryogen spray system), not an AI/imaging device. Therefore, MRMC studies and AI effectiveness are irrelevant to this submission.

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

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly relied upon is the established clinical efficacy and safety of cryogen spray systems, particularly those using the specified chemical composition, for the treatment of various skin lesions, as evidenced by the predicate devices. This can be considered accepted clinical practice and outcomes data from previously cleared devices and general medical knowledge.

8. The Sample Size for the Training Set

Not applicable. The Nuance Freeze Spray System is a physical device, and its clearance is based on substantial equivalence rather than a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this device.

Summary of the Basis for Clearance:

The Nuance Freeze Spray System gained 510(k) clearance based on Substantial Equivalence to legally marketed predicate devices:

• Primary Predicate: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K982506)
• Secondary Predicates: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K881349) and (K944221)

The "study" that proves the device meets the acceptance criteria is effectively this comparison demonstrating substantial equivalence. The core arguments for substantial equivalence are:

• Identical Indications for Use: The Nuance Freeze Spray System is intended for the treatment of the same specific skin lesions as the predicate devices.
• Identical Technical Characteristics (Cryogen Composition): The cryogen used (1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane, also known as R-404a) is stated to be the "exact same chemical composition and formulation as the predicate device."
• Similar Delivery Method: The methods for delivering the cryogen are described as "similar to the predicate."
• No New Issues of Safety or Efficacy: The statement explicitly says, "Nuance Freeze Spray System and its predicate devices do not raise any new issues of safety or efficacy."

Therefore, the "acceptance criteria" for the Nuance Freeze Spray System's clearance were met by demonstrating that it is fundamentally the same in terms of composition, intended use, and operational principles as already cleared devices, thereby inferring equivalent safety and effectiveness without requiring a new clinical performance study.

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Planmed Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planned Nuance or Planmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software.

The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.

Planmed Nuance DigiGuide is a digital biopsy imaging system. This system is compatible with Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. .

The Planmed Nuance DigiGuide system consists of the FFDM X-ray unit (Planmed Nuance or Planmed Nuance Excel) that is equipped with the needle guidance unit and the acquisition workstation (AWS), including a personal computer with the Nuance Manager 3 software, which is used for acquiring mammographic images, determining the lesion coordinates, and taking the biopsy.

This document describes the Planmed Nuance DigiGuide, a stereotactic biopsy system for Full Field Digital Mammography (FFDM). The submission is a 510(k) premarket notification (K121963) to the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for the Planmed Nuance DigiGuide does not explicitly define quantitative acceptance criteria for its performance. Instead, it relies on a comparison to a predicate device and qualitative assessments.

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

• Sample Size: 20 stereotactic biopsies.
• Data Provenance: Conducted at a mammography screening facility. The information does not explicitly state the country of origin, but the manufacturer is based in Finland. It is a prospective clinical test.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the 20 stereotactic biopsies. It mentions "a mammography screening facility, which already had long experience in using the previous Planmed DigiGuide system," implying experienced healthcare professionals were involved in the clinical evaluation.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for the clinical test set. It describes the "end result" of the comparison study, suggesting a consensus or evaluation process by the clinical site's staff.

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 versus without AI assistance?

No MRMC comparative effectiveness study was mentioned. This device is a hardware system for biopsy guidance, not an AI-assisted diagnostic tool for human readers. The clinical test was a comparison of the new hardware system to its predicate, focusing on image quality, accuracy, and reliability during the biopsy procedure.

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

This is not applicable as the Planmed Nuance DigiGuide is a hardware system for biopsy guidance, requiring human operation. It is not an algorithm with standalone performance.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was likely defined by the success and accuracy of the biopsy procedure itself, including successful tissue acquisition and the clinical assessment of the system's performance (image quality, accuracy, reliability) by experienced users at the mammography screening facility. It is implied to be expert clinical assessment rather than pathology or outcomes data specifically. The statement "The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use" suggests a clinical consensus on performance.

8. The Sample Size for the Training Set

No training set is mentioned as this device is a hardware system, not a machine learning algorithm requiring a separate training set.

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

Not applicable, as there is no training set for this device.

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Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units.

The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.

The Planmed Nuance Excel is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Nuance utilizes an amorphous selenium based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data.

The workflow with Planmed Nuance Excel is controlled from the acquisition workstation and Planmed Nuance Manager 3 image acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality work list. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

The provided text is a 510(k) summary for the Planmed Nuance Excel, a Full Field Digital Mammography (FFDM) system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC effectiveness studies cannot be extracted from the provided text.

The document primarily states:

• Its intended use for screening and diagnosis of breast cancer, similar to traditional film/screen mammography.
• That it generates digital mammograms to detect breast cancer at an early stage.
• That its use is allowed only under the supervision of a healthcare professional.
• That it is considered substantially equivalent to the predicate device, Siemens Mammomat Novation DR, implying it is "as safe and effective."

A table of acceptance criteria and reported performance, details on study design, sample sizes, expert involvement, and ground truth are typically found in clinical evaluation reports, technical reports, or detailed performance studies, which are not part of this 510(k) summary.

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Nuance Universal Composite:

• Direct restorations of anterior or posterior teeth (Class I Class V) .
• Diastema closures .
• Intraoral repairs of fractured crowns/bridges ●

Nuance Posterior Composite:

• Direct restorations of Class I and Class II cavities .

Nuance Flowable Composite:

• Direct restorations of anterior or posterior teeth .
• Cavity base/liner .
• Intraoral repairs of fractured crowns/bridges .

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Discus Dental, LLC concerning dental composite materials. It is a regulatory document and does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information to fill in the table or answer the questions. The document is strictly about the FDA's decision on the substantial equivalence of the dental composites to legally marketed predicate devices.

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The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.

The Planmed Sophie Nuance Classic is a conventional mammography x-ray system utilizing films and cassettes. This product is a modification of the previous devices Planmed Sophie and Planmed Sophie Classic, where the changes made are concentrated on the lower shelf construction (with easier assembly and better serviceability), a new Flex AEC system, more modern overall design and enhanced user friendliness. The modification also serves as a base to an easy upgradeability to full field digital imaging use in the future.

This document is a 510(k) summary for a mammographic x-ray system, the Planmed Sophie Nuance Classic. It establishes substantial equivalence to previously marketed predicate devices rather than providing information about specific acceptance criteria and a study proving a device meets them.

Therefore, the requested information elements related to acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication, MRMC, standalone performance), and ground truth establishment are not available in the provided text.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification, regulation number.
• Manufacturer Information: Name, address, contact persons.
• Intended Use: To produce radiographs of the human breast, with accessories for different diagnostic needs.
• Product Description: A conventional mammography x-ray system utilizing films and cassettes, described as a modification of previous Sophie models with improvements in shelf construction, AEC system, design, and user-friendliness, and future upgradeability to digital.
• Substantial Equivalence: A list of predicate devices (Planmed Sophie models) to which the new device is considered substantially equivalent in design, composition, and function, concluding it is "as safe and effective as the predicate devices."
• FDA Correspondence: Official letter from the FDA confirming the substantial equivalence determination and outlining regulatory requirements.

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