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510(k) Data Aggregation
(113 days)
IZI Medical Products LLC
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.
| Test/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Surgical Simulations on Phantom Models | The device accurately navigates and assists in pedicle screw placement in a simulated surgical environment with the 7D Surgical System, demonstrating equivalent performance to the predicate. | Performed to verify absolute accuracy, repeatability of accuracy, and navigation accuracy with the 7D Surgical System. |
| ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems | Compliance with the standard for measuring positional accuracy of computer-assisted surgical systems. | Accuracy testing performed according to this standard to verify absolute accuracy and repeatability of the device and navigation accuracy. |
| Target Registration Error (TRE) Evaluation | TRE should demonstrate acceptable clinical accuracy of the system on phantom models in a clinical simulated environment. | Used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. |
| Biocompatibility Profile | Same biocompatibility profile as the reference device K1423244. | The IZI Pedicle Access Kit has the same biocompatibility profile as the reference device K1423244. |
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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(96 days)
IZI Medical Products LLC
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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(152 days)
IZI MEDICAL PRODUCTS LLC
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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(210 days)
IZI MEDICAL PRODUCTS LLC
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
| Acceptance Criteria (What the device claims to do, or what needs to be met) | Reported Device Performance (How the device performed in testing) |
|---|---|
| Compatibility with Medtronic StealthStation® System | The "IZI Disposable Accessory with the Medtronic StealthStation S7" study was conducted to ensure compatibility. It verified product performance in the StealthStation® patient registration process and measured navigation accuracy. |
| Accuracy and Precision (Dimensional Analysis) | A "Design Verification - Dimensional Analysis" study was performed. All critical dimensions affecting passive reflective marker locations and probe tip location were measured against the predicate device. The CpK (Process Capability Index) of all dimensions were reported to be greater than 1.0, indicating the process is capable of producing items within specifications. |
| Comparable Performance to Predicate Device (Patient Registration & Navigation Accuracy) | The "IZI Disposable Accessory with the Medtronic StealthStation S7" study concluded that the IZI Disposable Passive Accessory performs comparably to the Medtronic Planar Probe with manually mounted Spherz regarding patient registration and navigation error. |
| Biocompatibility | A cytotoxicity test was performed. The test confirmed that "the product does not cause any cell lysis or toxicity." The materials and components were known to be biocompatible or have a history of use in similar medical devices. The manufacturing process does not use cleaning agents or chemicals. |
| Sterility | The device is provided as sterile. (No specific test results from this document, but implied by classification and indication). |
| Single Use | The device is designed for single use. (This is a design characteristic, not a performance metric to be tested against, but an acceptance criterion for its intended use model). |
| Physical Dimensions and 3D Locations of Marker Post Relative to Probe Tip | In the comparison table, it is stated to be "Same as the Medtronic Passive Planar Probe" and the comparison of technology is "Identical". The dimensional analysis study confirmed that "All critical dimensions that affect the passive reflective marker locations and the probe tip location were measured in the Study against the predicate device. The CpK of all dimensions are greater than 1.0." indicating that this specific criterion was met. |
| Probe Tip Material | The subject device uses Stainless steel (303 stainless steel), which is comparable to the predicate's Stainless steel (630 stainless steel). Both are stainless steel. |
| Passive Reflective Marker | The subject device's markers are "Identical to Spherz, permanently mounted onto the probe post". This is deemed identical to the predicate's markers, which are provided separately for manual mounting. |
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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