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The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision.
• Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

• Seal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site.
• Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

The Virtue Male Sling is an implantable, suburethral support sling intended for the surgical treatment of male stress urinary incontinence (SUI). The four-arm design of the Virtue Male Sling provides a dual mechanism of action by providing both compression of the bulbous urethra and proximal urethral elevation. The Virtue Male Sling is constructed of non-absorbable medical grade knitted, monofilament polypropylene and is intended to be permanently implanted.

The Virtue Introducer is used to facilitate transobturator and pre-pubic passages during the surgical placement of the Virtue Male Sling. The introducer is manufactured from polycarbonate thermoplastic elastomer (handle) and medical grade stainless steel (needle). The Virtue Introducer is only to be used with the Virtue Male Sling System in accordance with the Instructions for Use.

The Virtue Male Sling System with Alexis Wound Retractor includes one (1) Virtue Male Sling, one (1) single-use Virtue Introducer and one (1) Alexis Wound Retractor intended to facilitate the placement of the Virtue Male Sling.

The provided FDA 510(k) summary (K231891) for the Virtue Male Sling System with Alexis Wound Retractor indicates that performance data was not necessary for the substantial equivalence determination.

Therefore, the document does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The conclusion is based on the subject device having:

• Identical intended use
• Identical target population
• Identical sterilization technique
• Identical biocompatibility features
• Identical overall device design features
• Identical duration of use

compared to its predicate device (K113496, also the Virtue Male Sling System with Alexis Wound Retractor). The submission focused solely on revised labeling, which included:

• Adding a contraindication to align with other Coloplast mesh Instructions for Use (IFU) manuals.
• Updating adverse events based on post-market surveillance and literature analysis.
• Updating procedure details aligned with current literature.

The FDA determined that these labeling changes "do not raise questions of safety or effectiveness."

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The Virtue RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Smart RF Handpiece:
The Smart RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types I-V.
The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles.

Exact RF Handpiece:
The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles.

Deep RF Handpiece:
The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.

The VirtueRF device is a radio frequency output device using 0.5MHz, 1MHz & 2Mhz to deliver radio frequency energy to the human body with 3 applicators that attach to the connecting cable. The energy is applied to the human body using sterile disposable needle arrays consisting of 36 needles, 12 needles, o 1 needle. This product consists of main body, SmartRF Bipolar handpiece, DeepRF Bipolar handpiece, ExactRF Monopolar handpiece, connector cable, grounding plate for ExactRF, cooling plate for the DeepRF, foot switch and power cord.

The provided text is a 510(k) summary for the Virtue RF device, an electrosurgical cutting and coagulation device. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial to prove de novo effectiveness or meeting specific performance acceptance criteria for a novel device. As such, the document does not contain information typically found in a study demonstrating a device meets acceptance criteria involving human or animal subjects, ground truth, or statistical measures of performance like AUC, sensitivity, or specificity.

Instead, the submission demonstrates substantial equivalence primarily through:

1. Bench testing: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) and biological compatibility (ISO 10993-1).
2. Thermal effect tests: Performed on four types of tissues (liver, kidney, muscle, and skin) as guided by FDA for electrosurgical devices.
3. Direct comparison of technological characteristics: Side-by-side tables comparing the proposed device's various handpieces (Smart RF, Exact RF, Deep RF) with its own predicate device (Virtue RF K202415) and other reference devices (Primaeva Medical Miratone System K082391, Agnes K192728, and Agnes K160469, though K160469 is not explicitly listed as a reference device, it appears in a comparison table for Exact RF).

Therefore, I cannot provide the detailed acceptance criteria and study information requested in the prompt, as these elements are not part of this specific type of regulatory submission. The document concludes that "Substantial equivalence is supported by the performance testing and there are no new questions of safety or effectiveness."

To explicitly address your points:

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

• Acceptance Criteria for Bench Testing: Adherence to the listed IEC standards (e.g., meeting specific safety thresholds for electrical current, electromagnetic emissions, and biological compatibility). The "reported device performance" is that it passed these tests.
• Acceptance Criteria for Thermal Effect Tests: The criteria would be to demonstrate substantial equivalence to the predicate device in terms of thermal effects on tissues. The "reported device performance" is that the "Test shows that the VirtueRF is substantially equivalent to the predicate device."
• Acceptance Criteria for Technological Characteristics: The criteria are for the proposed device's features (Source of energy/Modality, Radiofrequency, Output energy type, Electrode type, Max Power, RF Duration, Number of Needles, Grounding Mechanism, Cooling Modality) to be "Same" or "Similar" to the predicate/reference devices, with justifications where there are differences (e.g., "Similar; same as reference device" or "Same as reference; similar to predicate device"). The "reported device performance" is detailed in the comparison tables provided in the document (pages 6-8).

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

• Not applicable for this type of submission. The "tests" here are bench tests on the device's hardware and thermal effects on tissues, not clinical trials on human subjects. The tissue tests would likely use an ex vivo or in vivo animal model, but details on sample size or provenance are not provided.

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):

• Not applicable. Ground truth from human experts is not used for this type of technical and bench testing-focused submission.

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

• Not applicable. No expert adjudication is involved.

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

• Not applicable. This device is not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

• Not applicable. This is not a software algorithm; it's an electrosurgical device.

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

• For the thermal effect tests, the "ground truth" would be objective measurements of tissue coagulation or heating, compared to measurements from the predicate device. For technical standards, the "ground truth" is adherence to the specified parameters in the IEC and ISO standards.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning device.

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

• Not applicable.

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The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz.

1MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V.

2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.

The VirtueRF device is a radio frequency output device using 1MHz & 2Mhz to deliver radio frequency energy to the human body with an applicator attached to the connecting cable. The energy is applied to the human body using a sterile disposable needle array consisting of 36 needles. This product consists of main body, Needle Bipolar RF (Smart RF) handpiece cable, foot switch and power cord.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VirtueRF device:

Based on the provided K202415 510(k) Summary for the VirtueRF device, the submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and standard performance testing. This type of submission generally does not include extensive clinical studies with specified acceptance criteria regarding diagnostic performance or human-AI comparative effectiveness, as it's not a diagnostic AI device.

Therefore, many of your requested points regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable in this context. The acceptance criteria here are related to meeting safety, electrical, biological, and thermal performance standards to demonstrate equivalence to existing devices.

Nonetheless, I will extract what information is present or clearly implied.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not present for the efficacy or diagnostic performance as those types of studies were not conducted or described. The "test set" in this context refers to the samples used for the engineering and bench testing (e.g., tissue samples for thermal effect tests, electrical testing setup), not a clinical trial test set for diagnostic performance. The document does not specify the number of tissue samples or the specifics of the electrical test configurations used.

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

This information is not applicable as the submission is not for a diagnostic device or an AI algorithm requiring expert-established ground truth for performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, which the VirtueRF electrosurgical system is not.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone algorithm performance study was not done. The VirtueRF is a medical device, not a standalone AI algorithm for diagnostic purposes. Its performance is evaluated through engineering, electrical, biocompatibility, and thermal tests, and comparison to predicates, not through AI-specific performance metrics.

7. The Type of Ground Truth Used

For the thermal effect tests, the "ground truth" would be established by direct physical measurements of temperature changes and tissue effects, validated against established scientific principles and comparison to the predicate device's known effects. This is a scientific and engineering ground truth rather than a clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable. The VirtueRF is a hardware device, not an AI model that requires a "training set."

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

This information is not applicable for the reasons stated above.

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The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

The Diagnosoft Virtue is software that runs on Windows-based operating systems to view and analyze MR images of the heart in DICOM format.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Diagnosoft, Inc. Virtue device:

Based on the provided K111833 510(k) summary, the device Virtue is a software for viewing and analyzing MR images of the heart. The document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices for its intended use as a "Picture archiving and communications system" that performs viewing, image manipulation, communication, printing, and quantification of images.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not provide any details about a test set, its sample size, or the provenance of any data used for testing.

2. 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 mention any test set, experts, or ground truth establishment.

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

   • The document does not mention any test set or adjudication method.

4. 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:

   • A MRMC study was not conducted or reported. The Virtue device is described as software for viewing and analysis, not an AI-assisted diagnostic tool in the sense of providing an interpretation or assisting a reader in making a diagnosis beyond image manipulation and quantification.

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

   • This document does not describe a standalone performance study. The device is a "Picture archiving and communications system" designed for human interaction.

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

   • The document does not describe the use of any ground truth, as no clinical performance study for diagnostic accuracy is detailed.

7. The sample size for the training set:

   • The document does not mention any training set, as it's not describing an AI/machine learning model in the context of diagnostic assistance.

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

   • The document does not mention a training set or ground truth establishment for it.

Summary of what the document focuses on:

The K111833 submission for Diagnosoft, Inc. Virtue is a "traditional 510(k)" for a Picture Archiving and Communications System (PACS) software. The evidence provided and accepted by the FDA for this type of device typically revolves around demonstrating "substantial equivalence" to existing legally marketed predicate devices in terms of:

• Intended Use: The Virtue's intended use is broad, covering viewing, image manipulation, communication, printing, and quantification of images from CT or MRI.
• Technological Characteristics: Its operational and fundamental characteristics are compared to predicate devices like the Philips Easy Vision Workstation and Harp 2.06.
• Safety and Effectiveness: The conclusion is that "any differences do not affect the product's safety or effectiveness." This often relies on software verification and validation activities (V&V) to ensure functions work as designed, adhere to software engineering best practices, and don't introduce new risks, rather than a clinical performance study with diagnostic endpoints.

Therefore, for this specific device and submission type, the absence of detailed clinical study performance data, acceptance criteria, and ground truth information is expected as it falls under a different regulatory pathway than novel diagnostic AI algorithms.

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The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically . retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision.
• . Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

• . Scal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site. ●
• Access the thoracic cavity or other soft tissue retraction during cardiac and . general surgical procedures through an atraumatically-retracted incision.

The Coloplast Virtue Male Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only. The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large. The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box.

The Coloplast Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K111881) is not an AI/ML device. It is a surgical mesh system and wound retractor. The provided text describes the device's technical characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating device performance relative to such criteria that would typically be associated with AI/ML systems.

The 510(k) summary explicitly states:

• "Summary Of Clinical Tests Submitted (As Applicable): Not applicable"
• "The Virtue System and Alexis Retractor devices have been subjected to biocompatibility and mechanical testing and were found substantially equivalent to the predicates per 510ks K101297 and K041711; thus, no additional biocompatibility or mechanical testing was conducted to support this Special 510(k)."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies related to AI/ML performance, as these concepts are not relevant to this specific device and are not discussed in the provided regulatory submission.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The modified Coloplast Virtue Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

This document describes the 510(k) summary for the Coloplast Virtue™ Ventral Urethral Elevation Sling System. The submission claims substantial equivalence to previously cleared devices (K082640 and K091152).

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria or detailed reported device performance in a quantitative manner. The submission relies on demonstrating substantial equivalence through "bench testing compared to the predicate device and existing specifications." This implies that the 'acceptance criteria' were met if the bench test results for the modified device were comparable to the predicate and fell within established specifications, but these specifics are not provided in the summary.

Since no specific performance metrics are provided in the document, a table cannot be constructed with performance data.

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

The document only mentions "bench testing." It does not specify a sample size for the test set, nor does it provide any information on data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies. Bench testing typically refers to laboratory-based evaluations, not human or observational data.

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

Since only "bench testing" is mentioned and there are no clinical studies or human-involved test sets described, there is no information provided regarding experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

As there are no clinical studies or human-involved test sets described, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "nonclinical tests" and "bench testing." It does not mention any multi-reader multi-case comparative effectiveness study or any studies involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is a surgical sling system, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The "device performance" would refer to the mechanical and biological performance of the sling itself.

7. The Type of Ground Truth Used

For the "bench testing," the ground truth would be established by engineering and material specifications – i.e., whether the physical properties and performance characteristics (e.g., tensile strength, pore size, biocompatibility) of the modified device meet predefined engineering standards and are comparable to the predicate device. The document does not provide details on these specific ground truths.

8. The Sample Size for the Training Set

This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" with a sample size for machine learning is not applicable.

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

As explained above, the concept of a "training set" for this type of device is not applicable.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The modified Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve . and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

This 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document describes a medical device called the "VIRTUE Ventral Urethral Elevation Sling System" and its substantial equivalence to a previously cleared device. It details the device's components (polypropylene mesh with four arms, sleeves, sutures, and an introducer), its intended use for male stress urinary incontinence (SUI), and the regulatory classification.

The document is a regulatory communication from the FDA to Coloplast Corporation, confirming the substantial equivalence of the modified VIRTUE device. It does not include performance data, clinical study results, or specific acceptance criteria.

Therefore, I cannot provide the requested information from this text.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

The provided text is a 510(k) summary for the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System. The available information primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as a such a study (with specific performance metrics, ground truth, and reader studies) appears not to have been conducted or detailed in this 510(k) summary. The submission relies on comparative analysis and bench testing.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not give details on the number of samples or specific test cases.
• Data Provenance: Not specified. Given it's bench testing, it would likely be laboratory-generated data rather than patient 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 available in the provided document. The study described is bench testing and comparative analysis, not a clinical study involving experts establishing ground truth for performance metrics in a patient context.

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

• This information is not applicable and not available. Adjudication methods are typically used in clinical studies or reader studies where multiple experts assess cases. The described testing is 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

• No, an MRMC comparative effectiveness study was not done. The device is a surgical sling system, not an AI or diagnostic imaging device.

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

• Not applicable. The device is a physical surgical implant, not an algorithm.

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

• For the bench testing, the "ground truth" would be objective measurements of physical properties (e.g., tensile strength, elasticity, pore size) and material properties that are compared against predefined specifications or the predicate device's characteristics. The document implies comparison to the predicate device's known characteristics as the "truth" for equivalence.

8. The sample size for the training set

• Not applicable / Not available. The device is a physical product, not an AI algorithm that requires a training set. The "testing" involved bench testing, not machine learning model training.

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

• Not applicable / Not available. (See point 8).

In summary: The 510(k) summary focuses on demonstrating "substantial equivalence" of the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System to a legally marketed predicate device (AMS AdVance Male Sling System) through a comparison of design, materials, performance characteristics (via bench testing), and indications for use. It does not contain details of a clinical study with quantifiable acceptance criteria for diagnostic accuracy, reader performance, or patient outcomes that would typically involve experts, ground truth, or specific sample sizes in the manner implied by the questions.

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