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The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of a void in cancellous bone in the spine for Kyphoplasty.

The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.

The Osteo-site® Vertebral Balloon consists of a Y-connector with luer fitting, catheter with mandrel, and a balloon with radiopaque markers. The Y-connector is adhered to a strain relief fitting which is then adhered to the proximal end of the outer shaft. The mandrel ball is placed in a socket at the proximal end of the Y-connector that is coaxial to the catheter. The distal end of the catheter is welded to the proximal end of the balloon and the distal end of the mandrel is screwed into the distal end of the balloon. This construction allows for fluid to fill from the angled section of the Y-connector, around the mandrel, and into the balloon without obstruction. The mandrel can move freely longitudinally until the ball end meets the limits of the socket at the proximal end of the Y-connector. This controls the balloon expansion longitudinally. The radiopaque markers at the distal end of the mandrel are an imaging reference of balloon placement for the user. The proximal markers are visual indication of the balloon's placement. The exterior surface of the balloon is covered by a lubricant which eases access through the introducer cannula.

The provided text describes a medical device called the Osteo-site® Vertebral Balloon and its substantial equivalence submission to the FDA (K200763). However, it does not describe an AI/ML medical device or a study involving human readers and AI assistance for image interpretation.

Instead, this document focuses on the Osteo-site® Vertebral Balloon, a physical medical device used for kyphoplasty, and describes its mechanical and material performance testing in comparison to predicate devices, not an AI model's performance in medical image analysis.

Therefore, I cannot provide the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.

The acceptance criteria detailed in the document are for the physical properties and performance of the balloon device itself:

Acceptance Criteria and Reported Device Performance (Osteo-site® Vertebral Balloon)

The document states: "No clinical testing was conducted for this submission." This further confirms that the study is not related to human interpretation of images or AI performance.

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The Navigated Pedicle Access Kit is intended to be used in image guided surgery with the 7D Surgical System. The Navigated Pedicle Access Kit is intended for use in posterior spinal surgery to assist in the acurate placement of pedicle screws. The device is sterile and designed for single use.

The IZI Pedicle Access Kit consists of one pedicle access needle with cannula. The handle contains 4 retro-reflective Navigation Markers (Spherz K022074). The device is sterile and designed for single use. The patient-contacting components are the stainless-steel cannulas and needle. The product is used to gain access to the pedicle in image guided surgeries using the 7D Surgical System. The retro-reflective Navigation Markers (Spherz) that are attached to the handle allows the camera system of 7D Surgical System (K180352) to accurately locate where the tip of the needle is in space.

Here's a breakdown of the acceptance criteria and study information for the IZI Navigated Pedicle Access Kit, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format like typical sensitivity/specificity thresholds. Instead, it describes performance based on accuracy testing and conformance to standards. The reported device performance is demonstrated by its compliance with these tests and standards, showing that it performs as safely and effectively as the predicate device.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "phantom models" used in the non-clinical performance surgical simulations. It mentions "phantom models" generally.
• Data Provenance: The data is based on "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models." This indicates it's retrospective simulation data from a controlled lab environment, not from human patients. The country of origin for the data is not specified, but the applicant (IZI Medical Products LLC) is based in Maryland, USA, and the predicate device manufacturer (7D Surgical Inc.) is in Ontario, Canada, suggesting a North American context for the testing.

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

The document does not provide details on the number or qualifications of experts involved in establishing the ground truth for the non-clinical simulations. The "ground truth" for TRE is described as "measured physically or otherwise," implying objective physical measurements rather than expert consensus on images.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the evaluation appears to be based on objective physical measurements (e.g., TRE) in a simulated environment, not subjective assessment by multiple individuals.

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

No, an MRMC comparative effectiveness study was not conducted. This document describes a device (a physical surgical instrument) and its navigation accuracy when used with a surgical system, not an AI diagnostic algorithm that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone Performance:

Yes, a standalone performance assessment (algorithm only, without human-in-the-loop performance) was effectively done. The performance metrics (absolute accuracy, repeatability, navigation accuracy, and TRE) are for the device (IZI Navigated Pedicle Access Kit) and its interaction with the 7D Surgical System in a simulated environment. There isn't a "human-in-the-loop" component being evaluated in these specific non-clinical tests.

7. Type of Ground Truth Used:

The ground truth used was objective physical measurements in a phantom model. For TRE, it's defined 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 gold standard established by precise physical measurement to compare against the system's reported position.

8. Sample Size for the Training Set:

The document does not mention a "training set" or "training data." This submission is for a physical surgical device, not a machine learning or AI algorithm in the context of data training. The "device performance tests" are verification and validation activities, which are akin to testing, not training.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided.

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The CushionCast™ Moldable Cushion is to be used by trained medical professionals for stable support and positioning of patients undergoing radiation therapy or other treatment in a clinic or hospital setting.

The CushionCast™ is moldable stabilization cushions for radiation therapy patients. This product targets customers who require stabilization cushions for patients who are undergoing radiation therapy. The CushionCast™ is needed in order to mold to the shape of the patient's head to immobilize any movement during radiation therapy.

The cushion is constructed with a biocompatible and water resistant fabric and internal components, which include low viscosity casting resins that are sealed in pouches and polystyrene beads as filler material. To activate the cushion, the pouches are popped, and the internal components are mixed for 2 minutes. The plug inserted in the vent tube is removed prior to the molding process. The vent tube serves to expel excess air to allow for an accurate mold. The mixture of the Part A and Part B liquid plastics should yield a hardened mold. The fully cured mold provides a dimensionally stable cushion required by radiotherapy systems.

The provided text describes a medical device called the CushionCast™ Moldable Cushion and its 510(k) summary, which includes a claim of substantial equivalence to a predicate device, the Klarity Mold Cushions. However, the document does not contain specific acceptance criteria, reported device performance metrics in a structured table, details of a specific study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC comparative effectiveness study results as requested in the prompt.

The document mentions a "design verification study" was conducted to ensure dimensional stability and equivalent performance to the predicate, but it does not provide any specifics about this study, its methodology, or its results.

Based on the information provided, I cannot fulfill your request for a detailed description of acceptance criteria and the study proving the device meets them with the specific points you listed. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with quantifiable acceptance criteria.

Therefore, I must state that the requested information (items 1-9) is not present in the provided text.

The only relevant snippet is:

"A design verification study was conducted to ensure that the dimensional stability of the CushionCast™ meets necessary requirements. The study also indicated that the CushionCast™ performs equivalently to the Klarity Mold Cushions. It is reasonable to conclude that the CushionCast™ and Klarity Mold Cushion are substantially equivalent with respect to use, safety, and effectiveness."

This statement confirms a study was done for "dimensional stability" and "equivalent performance," but it does not provide any of the specifics to answer your numbered prompts.

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The MDT Navigable Brain Biopsy Cannula is for use in stereotaxic biopsy of cranial tissue. The MDT Navigable Brain Biopsy Cannula is a pre-sterilized, single-use, sidecutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System.

The MDT Navigable Brain Biopsy Cannula contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotaxic biopsy of cranial tissue. The device is compatible with Medtronic's StealthStation® Image Guided Surgery System. Like the predicate devices, both devices are pre-sterilized, single-use, stainless steel devices and use a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

The MDT Navigable Brain Biopsy Cannula components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.

I apologize, but this document does not contain the specific information required to complete your request. The document is a 510(k) premarket notification acceptance letter and summary for a medical device (MDT Navigable Brain Biopsy Cannula).

While it mentions "performance testing" and "bench testing" were conducted, and that the device performs "comparably to the predicate device," it does not provide specific acceptance criteria, reported device performance metrics, or details about the study design (e.g., sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types for training or test sets, or training set sample sizes).

The document's primary focus is to establish substantial equivalence to a predicate device based on similar intended use and technological characteristics, not to detail the clinical trial or performance study's methodology or outcomes in the way you've requested.

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The Disposable Passive Accessory is intended to be used for anatomy palpation in image guided surgeries with Medtronic StealthStation® System. The device is sterile and designed for single use.

The IZI Disposable Passive Accessory contains one disposable point probe mounted with five passive reflective sphere markers, as well as ten additional passive reflective sphere markers. The Disposable Passive Accessory is intended to be used for anatomy palpation and registration in image guided surgeries with the Medtronic StealthStation® system. The device is sterile and designed for single use.

The Disposable Passive Accessory provides a single-use alternative to Medtronic reusable parts. The Disposable Passive Accessory is constructed by a dimension stable thermoplastic handle where five passive reflective sphere markers are mounted on, with a stainless steel tip that is used to register and locate patient anatomical structure in an image guided surgery using the Medtronic StealthStation® System. The permanently mounted passive reflective spheres are at the same three dimensional locations as the Medtronic predicate product. In an IGS procedure, the two cameras of the StealthStation® captures the reflective light from the five sphere markers for the System to calculate and determine the location of the stainless tip and the position of the probe.

The provided document, K142344, describes the substantial equivalence of the IZI Disposable Passive Accessory to predicate devices for use in image-guided surgeries with the Medtronic StealthStation System. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that two non-clinical bench tests were conducted. However, it does not provide specific details on the sample sizes (e.g., number of devices tested, number of measurements taken) for these tests.

• Design Verification - Dimensional Analysis: No specific sample size is mentioned, only that "All critical dimensions...were measured in the Study."
• Design Verification - IZI Disposable Accessory with the Medtronic StealthStation S7: No specific sample size is mentioned for the number of accessories or the number of tests performed on the dummy head. The study used "a pre-scanned Medtronic IGS dummy head."

The data provenance is retrospective, as these are bench tests conducted by the manufacturer for regulatory submission, rather than prospective clinical trials. The country of origin for the data is implicitly the United States, given the submission to the FDA by a US-based company (IZI Medical Products LLC, Maryland).

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

No explicit information is provided regarding the use of external experts to establish ground truth for the bench tests. The ground truth for the dimensional analysis would likely be engineering specifications and measurements. For the StealthStation compatibility test, the ground truth for navigation accuracy would be established by the known true positions within the pre-scanned dummy head, and the operational functionality would be against the expected behavior of the Medtronic StealthStation System. These are internal engineering and performance benchmarks rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the studies are non-clinical bench tests. The performance metrics (CpK, navigation error) are quantifiable and objective, not requiring human interpretation or adjudication in the medical sense.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a passive accessory (a probe) for an image-guided surgery system, not an AI-based diagnostic tool that assists human readers in interpreting medical images. Therefore, the concept of "human readers improving with AI assistance" does not apply to this device.

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

This device is a hardware accessory (a probe), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's function is inherently human-in-the-loop as it is used by a surgeon for palpation and registration.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these non-clinical bench tests was based on:

• Engineering Specifications and Measurements: For the "Design Verification - Dimensional Analysis," the ground truth was the engineering specifications of the predicate device and the physical measurements taken.
• Known Physical Coordinates/System Functionality: For the "Design Verification - IZI Disposable Accessory with the Medtronic StealthStation S7," the ground truth for navigation accuracy was derived from the known positions within the pre-scanned Medtronic IGS dummy head and the expected operational parameters of the StealthStation® System itself.

8. The Sample Size for the Training Set

This device is not an AI/machine learning model, so there is no training set.

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

As there is no training set for an AI/machine learning model, this question is not applicable.

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The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of cranial tissue using BrainLab AG's VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

BL Navigated Biopsy Needle contains a calibrated biopsy cannula that is used with a compatible image guided surgery navigation system in stereotactic biopsy of cranial tissue. The device is compatible with specified BrainLab navigation systems (see intended use section below). Like the predicate device, the BL Navigated Biopsy Needle is a pre-sterilized, single-use, stainless steel device and uses a side-cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

BL Navigated Biopsy Needle's components include a navigable biopsy cannula, a biopsy cannula stop with screw, a stop adjustment tool and an aspiration tube.

The provided text describes a 510(k) premarket notification for the "Navigable Brain Biopsy Cannula Set" (K140705). This document focuses on demonstrating substantial equivalence to predicate devices, rather than on a study proving the device meets specific acceptance criteria in the context of AI/algorithm performance. The device described is a physical medical instrument (a biopsy needle), not an AI or software-based device.

Therefore, many of the requested criteria about AI/algorithm performance studies (e.g., sample size for AI test/training sets, ground truth establishment for AI, MRMC studies for AI, standalone AI performance) are not applicable to the information contained in this 510(k) summary.

However, I can extract the relevant information regarding the performance testing conducted for this physical device.

Here's a breakdown of the available information:

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

The document does not explicitly state numerical "acceptance criteria" for the performance tests in a table format, nor does it provide quantitative performance metrics beyond confirming the tests were conducted and the device "performs as intended."

Reported Device Performance:

• Tissue extraction testing: Verified the ability of the device to sample tissue.
• Navigation testing: Verified compatibility and accuracy with specified navigation systems (BrainLab AG's VectorVision navigation system).
• Real-time shelf life testing: Verified no change in visual attributes, dimensional characteristics, or tensile strength after 5 years of real-time storage.
• Biocompatibility testing:
  • Cytotoxicity: Performed in accordance with ISO 10993-5.
  • Pyrogen Testing: Performed in accordance with ANSI/AAMI ST72:2011.

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

• Sample Size: Not specified for any of the performance tests (tissue extraction, navigation, shelf life, or biocompatibility).
• Data Provenance: Not specified. These appear to be bench tests, not clinical studies involving patient data.

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. The ground truth for this physical device's performance tests would be based on objective measurements and established standards (e.g., tissue presence in a sample, accurate navigation tracking, material integrity, biocompatibility standards), not expert consensus on images or interpretations.

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

• Not applicable for the type of bench testing 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

• No, an MRMC study was not done. This device is a physical biopsy cannula, not an AI or software diagnostic tool, so such a study is not relevant.

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

• No, a standalone algorithm performance study was not done. This device is a physical biopsy cannula.

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

• Tissue extraction testing: The ground truth would likely be the physical presence and integrity of the tissue sample obtained.
• Navigation testing: The ground truth would be the known, actual position or trajectory of the cannula compared to the system's displayed position, verified through metrology or other accurate measurement methods.
• Shelf life testing: Ground truth would be objective measurements of material properties (visual, dimensional, tensile strength) against baseline or established specifications.
• Biocompatibility testing: Ground truth is defined by the standards (ISO 10993-5, ANSI/AAMI ST72:2011) which specify thresholds for cytotoxicity and endotoxin levels.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI or machine learning algorithm requiring a training set.

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

• Not applicable. As above, this is a physical device, not an AI/ML algorithm.

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emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.

emBRACE is a radiolucent foam cushion used during radiologic visualization of the breast. emBRACE is non-sterile and is a single use device.

emBRACE will be offered in the following configurations for ease of use dependent o the radiological system used:

• Product Number 00283-001 for use on an 18x24cm bucky. .
• Product Number 00283-100 for use on a 25x29cm bucky. .
• Product Number 00283-200 for use on a 29x30cm bucky. .

The provided text describes the regulatory clearance for the "emBRACE" device, a radiolucent foam cushion used for patient comfort and positioning during mammography. However, it does not include the details typically found in a study proving a device meets acceptance criteria related to AI/ML or diagnostic performance.

The document is a 510(k) summary for a Class II medical device (IZH) and Class I (IYX) that received clearance based on substantial equivalence to a predicate device (MammoPad® Radiolucent Cushion). This type of submission generally focuses on demonstrating that the new device has the same intended use, principles of operation, and overall technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate device. It typically does not involve clinical performance studies with specific acceptance criteria as would be expected for a diagnostic or AI-based device's accuracy or efficacy.

Therefore, many of the requested fields cannot be filled from the provided text as the information is not present.

Here's what can be extracted and what cannot:

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

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

• Not applicable/Not provided. This type of information would be relevant for a clinical performance study, which is not described as being conducted for this 510(k) submission.

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

• Not applicable/Not provided. No clinical performance study requiring expert ground truth is described.

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

• Not applicable/Not provided. No clinical performance study requiring adjudication 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

• No, this was not done. The device is a physical cushion, not an AI or diagnostic software.

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

• No, this was not done. The device is a physical cushion, not an algorithm.

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

• Not applicable/Not provided. No ground truth establishment was necessary for this type of device and submission. The "ground truth" for a 510(k) of this nature is typically the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device requiring a training set.

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

• Not applicable/Not provided. This is not an AI/ML device requiring a training set.

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