Search Results

The Envision cover and Envision pad are intended as a microbial barrier between the patient and medical imaging electronics.

The Envision cover and Envision pad are used, without the need for ultrasound coupling gel, in adult and pediatric patients, for diagnostic ultrasound imaging, in sterile fields, that currently use an ultrasound coupling gel or fluid alone or in combination with a protective transducer cover, including ultrasound guided venous access, ultrasound imaging over surgical wounds, during transcutaneous biopsy; for intraoperative, endocavity, or transcutaneous imaging procedures; or to enhance acoustic coupling to difficult geometries.

The Envision Ultrasound pad and Envision Ultrasound cover (Envision) are microbial barriers for use during ultrasound procedures. The Envision device contains a coating that facilitates the acoustic coupling between the patient and ultrasound equipment without the need for traditionally ultrasound gel. This enables the clean transmission of sound waves between the transducer and patient without the mess of gels.

The Envision Ultrasound pad is comprised of four layers. The first layer is a crack and peel release liner that is removed by the customer to expose the adhesive layer (second layer) that sticks to the patient or the transducer within the cover. The third layer is a film carrier layer to hold the adhesive and coating layers together. The final layer is the coating layer, which is the acoustic couplant layer and is activated by using hydrating media, such as saline.

The Envision pad is sold as both a standalone pad and also sold as an integrated ultrasound cover (cover). The cover is a traditional CIVCO ultrasound cover, where one end of the cover is cut out, and the Envision pad, cut down to size, is sealed to the cover at the location of the cut out.

The document describes the Envision™ Ultrasound Cover and Pad, a device intended as a microbial barrier and acoustic coupler for ultrasound procedures. This device is compared to a predicate device (CIVCO General Purpose Transducer Cover K970513) and a reference device (EcoVue® Sterile and Non-Sterile Ultrasound Gels K181363).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by comparison to the predicate or reference device, or through meeting specific standards (e.g., ISO, ASTM). The "Reported Device Performance" column reflects the results of the non-clinical tests.

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

The document does not specify exact sample sizes for the test sets in most non-clinical studies. For example, it states "The Envision pad's ability to withstand viral penetration was performed to evaluate the barrier performance... in accordance with ASTM F1671-13," without detailing the number of samples tested under this standard. Similarly, for acoustic properties, specific sample sizes are not provided.

The data provenance is from non-clinical bench testing performed by the manufacturer (CIVCO Medical Instruments Co., Inc.). There is no mention of patient data (prospective or retrospective) or country of origin for such data, as this is a device clearance based on engineering and material performance.

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

This information is not applicable as the evaluation is based on non-clinical, objective measurements and compliance with established standards, rather than expert interpretation of medical images or conditions.

4. Adjudication method for the test set

This information is not applicable as the evaluation is based on non-clinical, objective measurements and compliance with established standards, not on subjective expert consensus.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ultrasound cover and pad, not an AI-powered diagnostic system. Clinical tests were explicitly stated as "not required to demonstrate substantial equivalence."

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical accessory for ultrasound, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Established standards and regulations: Such as ISO 10993 for biocompatibility, ASTM F1671-13 for viral penetration, ISO 11135 for sterilization, ASTM F1980-16 for accelerated aging, ISO 11607-2 and ISTA 2A for packaging.
• Direct measurement and comparison: For acoustic properties (impedance, sound velocity, density, pH) where the Envision device's physical properties are directly measured and compared against established ranges from a reference device (EcoVue® Sterile and Non-Sterile Ultrasound Gels).
• Functional tests: Water leak testing, rehydration testing, and simulated use testing to ensure the device performs its intended functions.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device. There is no concept of a "training set" for the Envision Ultrasound Cover and Pad.

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

This information is not applicable as this is not an AI/machine learning device.

Ask a specific question about this device

The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spationing and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical Envision 3D™: Image Guidance System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the Envision 3D™ integrated structured light scanner and/or user selected points. The system provides guidance data by displaying the locations of wireless optically tracked Envision 3D™ Spinal Instruments (examples include pedicle probe and awl) relative to the patient. Position and orientation data of tracked Envision 3D™ Spinal Instruments are linked to the preoperative scan data using the Envision 3D™ workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.

The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.

The Envision 3D™: Image Guidance System is comprised of 5 major components:

• 1. Cart
• 2. Arm
• 3. Head
• 4. Tracked surgical Envision 3D™ Spinal Instruments
• 5. Software

The provided text gives limited details about the acceptance criteria and a specific study proving the device meets them. However, it does mention non-clinical performance and accuracy testing. Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All accuracy specifications have been met" for the "Non Clinical Accuracy" testing. However, the specific numerical acceptance criteria for accuracy are not explicitly stated. It refers to ASTM F2554-10 for the measurement method but doesn't provide the targets.

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

• Test Set Sample Size: Not explicitly stated. The "Non Clinical Accuracy" testing was performed "on phantom models." The number of phantom models or specific test cases is not provided.
• Data Provenance: The Non-Clinical Accuracy tests were conducted on "phantom models" in a "clinical simulated environment." This indicates simulated, controlled environments rather than data from human patients. The country of origin of the data is not specified. It is a retrospective analysis of device performance on phantom models.

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

• Number of Experts: Not specified.

• Qualifications of Experts: Not specified.

  The ground truth for accuracy testing (Target Registration Error) is described as "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a measurement-based ground truth rather than expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable/Not specified. The accuracy testing described appears to be objective, measurement-based (comparing system output to physical ground truth), rather than requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document states, "A clinical trial was not required to demonstrate safety and effectiveness of the Envision 3D™: Image Guidance System. Clinical validation is unnecessary as the Envision 3D™: Image Guidance System introduces no new indications for use, device features are equivalent to the previously cleared predicate device identified." Therefore, no assessment of human reader improvement with AI assistance was conducted or reported.

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

The "Non Clinical Accuracy" testing refers to the "System's accuracy" using the Envision 3D™ on phantom models. This implies a standalone evaluation of the device's accuracy without a human-in-the-loop performance assessment. The system's ability to spatially position and orient surgical instruments is the core function being tested.

7. The Type of Ground Truth Used

The ground truth used for "Non Clinical Accuracy" testing, specifically for Target Registration Error (TRE), is described as "the ground truth position measured physically or otherwise." This suggests physical measurement or pre-defined true positions on the phantom models, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide information about a training set specifically for an AI/algorithm component. The device is referred to as an "Image Guidance System" utilizing an "integrated structured light scanner" and "software" that "links all system components," but it does not detail any machine learning or AI models requiring a distinct training dataset. The system seems to rely on established image processing and tracking algorithms rather than a trainable AI model in the context usually meant by "training set" for AI.

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

Since no separate training set or AI model requiring traditional training data is explicitly described, this information is not applicable or provided in the document.

Ask a specific question about this device

The Envision™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. ENVISION™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.

The ENVISION™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the ENVISION™ Test strip. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

This document describes the regulatory submission for the ENVISION™ Blood Glucose Test System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics as one might find for a novel device or AI/ML product.

As such, the information typically requested in your prompt (e.g., sample sizes for test/training sets, detailed ground truth establishment, MRMC studies, specific performance metrics like F1, accuracy, etc.) is not explicitly provided or applicable in the context of this 510(k) summary for a blood glucose monitor. Blood glucose monitoring systems are evaluated against established performance standards and predicate devices, which typically involve accuracy studies comparing device readings to a laboratory reference method.

However, I will extract and infer the closest available information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to the performance of the predicate device as the benchmark for "substantial equivalence." The reported device performance is a general statement of meeting this equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "clinical performance evaluation" without providing the number of subjects or samples.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be "prospective" in the sense that performance evaluations were conducted for the purpose of validating the consumer use for the user and the professional accuracy of the ENVISION™ system.

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

This type of information is not provided because blood glucose monitoring systems typically use a laboratory reference method (e.g., a YSI analyzer) as the "ground truth" for glucose concentration, not expert consensus on images or other subjective data. No mention of experts for ground truth is made.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for blood glucose measurements is typically an objective laboratory reference method, not an adjudicated expert opinion.

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

Not applicable. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is a blood glucose monitor.

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

The device itself is a standalone system (monitor + test strips) that provides a direct glucose reading. The "clinical performance evaluation" assessed its accuracy against a reference, which is essentially a standalone performance assessment in a clinical setting. There is no "human-in-the-loop" in the interpretation of the numerical glucose result from the device.

7. The Type of Ground Truth Used

The ground truth implicitly used for accuracy assessments in blood glucose monitoring systems is a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer). While not explicitly stated in the provided text, this is the standard practice for validating such devices. The document refers to "professional accuracy," which implies comparison to a highly accurate reference.

8. Sample Size for the Training Set

Not applicable. This device is a measurement system, not a machine learning model that requires a "training set" in the conventional sense. Its performance is based on the electrochemical reaction and calibrated sensor, not a learned algorithm from a large dataset.

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

Not applicable, as there is no "training set" in the context of this blood glucose monitoring device.

Ask a specific question about this device

EnVision is a light-cured orthodontic bonding adhesive that is designed to be used for the attachment of orthodontic appliances to teeth.

The device is a chromatic orthodontic bonding adhesive. This single paste bonding adhesive initially has a blue color that enhances ease of use. Upon curing, the final color takes on the shade of the tooth, rendering it unnoticeable. Envision has an extended working time and has a very fast light cure property that achieves high strength, allowing active archwires to be placed immediately. EnVision is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques

The provided text is a 510(k) summary and FDA clearance letter for the EnVision orthodontic bonding adhesive. It focuses on regulatory approval based on substantial equivalence to existing devices, product description, and intended use.

Crucially, this document does not contain any information regarding acceptance criteria, performance data, or a clinical study that would describe how the device meets such criteria. It's a regulatory document, not a scientific study report.

Therefore, I cannot provide the requested information from this text. The questions below would be answered with "information not found in the provided document."

Here is a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria (e.g., bond strength, cure time, discoloration limits) nor does it report the device's performance against such criteria. The clearance is based on substantial equivalence to predicate devices, implying similar performance is expected, but no specific data is presented.
2. Sample sized used for the test set and the data provenance: No test set is described, as no performance study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No test set or adjudication method 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: This device is an orthodontic bonding adhesive, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a physical product (adhesive), not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described as no performance study is detailed.
8. The sample size for the training set: No training set is applicable as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Envision™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implant after the attainment of a solid fusion mass. The Envision Anterior Cervical Plate System is intended for use under the following indications:

• Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e., fracture)
• Tumor
• Deformity (i.e., kyphosis, lordosis, and scoliosis)
• Spinal stenosis
• Pseudarthrosis
• Failed previous fusion

The Ortho Development Envision Anterior Cervical Plate System system is a cervical spinal fixation device, which consists of a variety of bone plates and bone screws. Fixation is provided by the insertion of bone screws thought the openings at each end of the plate into the anterior portion of vertebral bodies of the cervical spine. The devices are manufactured from Ti-6Al-4V alloy per ASTM F-136. The Envision Anterior Cervical Plate System functions to provide a means to fuse the cervical spine.

The provided text describes a submission for the Ortho Development Envision Anterior Cervical Plate System. This is a medical device designed for cervical spinal fixation.

Here's an analysis of the acceptance criteria and study information, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation describes non-clinical performance testing (mechanical testing), not a test set based on patient data. Therefore, the concept of a "test set" in the context of clinical data provenance or sample size doesn't apply directly here. The testing was conducted on manufactured devices.

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

This question is not applicable. The assessment was based on mechanical testing results against an ASTM standard, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This question is not applicable. The assessment was based on mechanical testing results, not a clinical adjudication process.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data and conclusion were not needed for this device."

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

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

7. The Type of Ground Truth Used

The ground truth used for the device's performance was compliance with a recognized industry standard (ASTM F1717-96 for mechanical testing). This standard defines accepted biomechanical performance characteristics for spinal fixation devices.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical implant, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

This question is not applicable for the same reason as above. There is no training set for this type of device.

Overall Context of the Submission:

It's important to note that this document is a 510(k) premarket notification for a medical device. The primary method for demonstrating "substantial equivalence" in a 510(k) is often through comparison to legally marketed predicate devices and non-clinical testing (like biomechanical), rather than extensive new clinical trials, especially when the technology is well-established. The FDA's letter explicitly states that they found the device "substantially equivalent" to predicate devices and that clinical data was not needed for this particular submission.

Ask a specific question about this device