Search Results

The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g. malignancy. When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.

The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling during a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.

The provided text is a 510(k) summary for the "EleVation Breast Biopsy System". This document focuses on demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies in the typical sense of a novel AI/medical device.

Therefore, the information requested regarding acceptance criteria, extensive studies, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not directly applicable or available in this document. The FDA 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and non-clinical performance testing.

Here's how to interpret the available information in the context of your questions:

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

The document doesn't present a table of specific clinical acceptance criteria (e.g., sensitivity, specificity, AUC) and corresponding reported performance values for diagnostic tasks. Instead, it refers to performance criteria for mechanical and functional aspects of the device.

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

• Not applicable for clinical diagnostic performance. The document describes non-clinical performance testing (e.g., mechanical tests), not a clinical study with a test set of patient data.
• Data Provenance: The studies are non-clinical and relate to engineering and mechanical performance of the device components.

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

• Not applicable. There is no "ground truth" in the diagnostic sense (e.g., pathology confirmed diagnosis) established by experts for this type of non-clinical device testing. The "ground truth" for the non-clinical tests would be the established engineering specifications and performance of the predicate device.

4. Adjudication method for the test set

• Not applicable. There is no clinical test set requiring expert 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

• Not applicable. This device is a biopsy system, not an AI diagnostic tool that assists human readers.

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

• Not applicable. This device is a physical biopsy system, not an algorithm.

7. The type of ground truth used

• Non-clinical/Engineering Ground Truth: The "ground truth" for the tests performed (Software Validation, Penetration Force Testing, Tensile Testing, Prime/Pierce Testing, Reliability Testing, Sample Mass Testing) would be established engineering specifications and the performance characteristics of the predicate device (K192948), to which the modified device is compared for substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device's non-clinical performance testing, as it's not an AI/machine learning device.

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

• Not applicable. (See point 8)

Ask a specific question about this device

The EleVation™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.

The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.

I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for the EleVation Breast Biopsy System, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's why the information you're looking for is not present:

• No Clinical Study Details: The document explicitly mentions "non-clinical tests" (e.g., Sampling Reliability, Prime/Pierce Reliability, System Lifetime Reliability, etc.) to demonstrate substantial equivalence. There is no mention of a clinical study involving human patients, AI assistance, human readers, or ground truth established by experts/pathology/outcomes data.
• No Acceptance Criteria Table with Performance: While "Performance Testing Summary" is a section, it lists the types of tests performed (e.g., "Sampling Reliability", "Needle Requirements") but does not provide quantitative acceptance criteria or corresponding reported device performance values for these non-clinical tests.
• No Information on AI/Human Reader Performance: The device is a mechanical biopsy system, not an AI-powered diagnostic tool. Therefore, questions about MRMC studies, human reader improvement with AI, or standalone algorithm performance are not applicable to this document.
• No Training/Test Set Details: Since no clinical study involving data sets is described, there's no information about sample sizes for training or test sets, data provenance, or methods for establishing ground truth.

In summary, this document is a regulatory clearance for a physical medical device based on non-clinical engineering and performance testing comparing it to a predicate device, not a report on a clinical trial or AI algorithm validation.

Ask a specific question about this device

The Elevation Spine Saber-C System is a cervical interbody for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.

The SABER-C System is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. ASTM F136. ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spike or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.

The provided text describes a 510(k) submission for the Elevation Spine Saber-C System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact numerical sample size for individual mechanical tests (e.g., number of devices tested for axial compression). It only states that "Three configurations of the Elevation Spine Saber-C System were tested". For the cadaver implantation study, the sample size is also not specified, only that "a cadaver implantation study was performed".
• Data Provenance: The data provenance is not explicitly mentioned (e.g., country of origin, specific testing facility). However, given that it's an FDA submission, the testing would typically be performed in a controlled laboratory setting, likely in the US or a country with comparable regulatory standards. The studies appear to be prospective in nature, as they involve testing the actual device configurations.

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

• This type of information is not applicable to the mechanical and cadaveric testing described. These tests rely on objective physical measurements and adherence to engineering standards (ASTM), not on expert human interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set:

• This is not applicable as the tests performed are objective mechanical and implantation studies, not studies involving human interpretation or consensus.

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

• A MRMC comparative effectiveness study was not conducted. The provided text describes mechanical performance testing and a cadaver implantation study, not studies involving human readers and interpretation of medical images.

6. Standalone (Algorithm Only) Performance Study:

• A standalone performance study of an algorithm was not conducted. This device is a physical intervertebral fusion system, not an AI/algorithm-based diagnostic or therapeutic tool. The testing focuses on its mechanical and physical performance.

7. Type of Ground Truth Used:

• The "ground truth" for the performance testing is based on objective engineering standards and physical measurements. For mechanical tests, this means adherence to the specifications and performance envelopes outlined in ASTM F2077-14 and F2267-11, and comparison to predicate device performance. For the cadaver study, successful implantation and observation of stability would serve as the "ground truth" for that aspect.

8. Sample Size for the Training Set:

• This information is not applicable. This submission details a physical medical device. There is no AI model or algorithm that requires a "training set" in the context described.

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

• This information is not applicable as there is no training set for an algorithm.

Ask a specific question about this device

The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.

The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.

The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.

The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.

This document describes the premarket notification for the Elevation Manual Wheelchair (K140023). Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices, particularly those in Class I, the "acceptance criteria" often refer to meeting established safety standards (like ISO standards) and demonstrating substantial equivalence to a predicate device. The "reported device performance" indicates how the new device fulfills these standards and compares to the predicate.

The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted according to international ISO standards. The document explicitly states: "The Elevation Manual Wheelchair has been tested to the following standards."

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size of devices, but rather indicated by testing "The Elevation Manual Wheelchair" against the listed ISO standards. This implies at least one device was tested to each standard, which is typical for mechanical device performance and safety testing.
• Data Provenance: The testing was non-clinical. The standards are international (ISO), making the origin of the testing methodology international. The manufacturer (PDG Product Design Group, Inc.) is based in Vancouver, British Columbia, Canada, suggesting the device and possibly the testing might have originated there, or at a contracted testing facility. The data is prospective in the sense that the testing was performed on this specific device to demonstrate its compliance.

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)

This is not applicable to this type of device. The "ground truth" for a mechanical wheelchair's performance and safety is established by its adherence to internationally recognized engineering and safety standards (ISO standards), rather than expert medical consensus or interpretation of images. The tests themselves are objective measurements against specified criteria within the ISO standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data or image interpretation where there's subjectivity. For objective mechanical testing against ISO standards, the results are derived directly from the test procedures.

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. An MRMC study is relevant for diagnostic imaging AI devices, not for a manual mechanical wheelchair.

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

Not applicable. This device is a mechanical wheelchair, not an algorithm or AI system.

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

The "ground truth" for this device's performance and safety is its conformance to established international safety and performance standards (ISO standards). These standards define the acceptable mechanical properties, stability, braking effectiveness, dimensions, material ignition resistance, etc. The results of non-clinical tests against these standards serve as the objective evidence of "ground truth."

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI or algorithm that requires a training set.

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

Not applicable. As noted above, there is no "training set" for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device