Search Results

The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 Software and a platform of the NAV31 platform family, is intended as a planning and intra-operative guidance system to enable open or percutaneous image-guided surgery.

The system can be used for intraoperative guidance where a rigid anatomical structure can be identified.

The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

The Stryker OrthoMap Express Knee system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided knee surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model of the patient's leg (femur and tibia). The computed model is based on an intra-operative anatomy survey of the leg. The system consists of a Stryker surqical software application (software), which runs on a platform, consisting of a Stryker computer, a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments.

The Stryker OrthoMap Express Knee 2.0 software is compatible with the NAV3i Platform Family. The NAV3i platform family is a family of platforms that. when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The NAV3i platform family consists of the following three platforms that have been previously cleared independently or with other Stryker surgical software applications:

• . Stryker NAV3 Platform (K141551)
• Stryker NAV3i Platform (K130874) ●
• Stryker NAVSuite3 Kit (K150301) ●

The platforms consist of the following components:

• Stryker computer
• Navigation camera ●
• IO-Tablet
• Monitor ●
• Mobile cart (if applicable) ●

The provided document is a 510(k) Premarket Notification for the Stryker OrthoMap Express Knee System, cleared by the FDA on July 7, 2016. This document details the device's intended use, comparison to predicate devices, and performance testing to demonstrate substantial equivalence.

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

Ask a specific question about this device

The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.

Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants.

Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Adaptor and associated Trackers to facilitate the placement of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.

The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.

The Navigated XIA® 4.5 Polyaxial Screwdriver, a Stryker Navigated Spine Instrument, is a manual tool for bone screw placement, insertion, and removal. The tip of the navigated screwdriver inserts into the screw head to turn it. The screwdriver also has an interface to allow a connection to the Rotational Navigation Adapter, a Stryker Spine Navigation System accessory, and to a handle.

The provided text is a 510(k) summary for the Navigated XIA® 4.5 Polyaxial Screwdriver. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, the document does not contain the specific level of detail required for a comprehensive answer to your request, especially regarding acceptance criteria and the specifics of a study proving device performance against those criteria as you would find for an AI/ML powered device.

This document describes a medical instrument, not an AI/ML powered device. Therefore, many of your requested points (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, ground truth used) are not applicable to this type of submission.

Based on the information provided for this instrument, here's what can be extracted and inferred:

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

Ask a specific question about this device

The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified.
The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including:
· Pedicle screw placement

The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine.

• · In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
• · When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

The Stryker SpineMap® 3D Navigation System is an image guided surgery system to enable open or percutaneous computer-assisted spinal surgery.
The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a CT image.
The system consists of a software application, smart instruments (e.g. patient/instrument trackers, pointers, navigated surgical instruments), and several accessories to enable the tracking of surgical instruments. The system also includes the SpineMask™ Tracker, a new patient tracking device.
The software application runs on a Stryker computer platform, consisting of a Stryker computer, a navigation camera and an IO-Tablet.

The provided document is a 510(k) summary for the Stryker SpineMap® 3D Navigation System and the Stryker SpineMask™ Tracker. It focuses on demonstrating substantial equivalence to predicate devices and outlines non-clinical testing. Crucially, the document explicitly states "No clinical testing has been conducted." Therefore, there is no study described that proves the device meets acceptance criteria through clinical performance.

However, the document details non-clinical acceptance criteria and the performance related to those:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

The document does not provide specific sample sizes for the "test set" in the context of clinical data because no clinical testing was performed. For non-clinical testing:

• Accuracy: Tested in phantom tests and cadaver tests. No specific sample size (number of phantoms or cadavers) is mentioned.
• User Needs: Validated in cadaver labs or simulated use tests. No specific sample size is mentioned.
• Data provenance: Not specified for non-clinical tests.

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

Not applicable as no clinical testing was performed. For User Needs validation (cadaver labs/simulated use), it mentions "users," but does not specify their number or qualifications.

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

Not applicable as no clinical testing was performed.

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 as no clinical testing was performed and the device is a navigation system, not an AI diagnostic/reader tool.

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

This refers to the performance of the navigation system components (software and hardware) independently, which is covered by the non-clinical tests for accuracy, software validation, electrical safety, etc. The "Accuracy" test specifically reports on the system's inherent navigation precision.

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

For the non-clinical tests:

• Accuracy: "Ground truth" would be established by precise measurement tools in phantom and cadaver settings, comparing the system's output to the known position/orientation.
• Other tests (Software, Electrical Safety, EMC, Sterilization, Biocompatibility): Ground truth is compliance with relevant industry standards (e.g., ISO, IEC, ASTM, ANSI/AAMI) and internal design specifications.

8. The sample size for the training set

Not applicable in the context of machine learning model training. The device is a navigation system, not an AI model that learns from training data in the traditional sense of AI diagnostics. Its software is validated against established specifications and standards.

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

Not applicable as there is no "training set" for an AI model. "Ground truth" for system design and verification is based on engineering specifications and adherence to international standards.

Ask a specific question about this device

The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available. The Stryker PROFESS™ system supports the following surgical procedures:

• Endoscopic sinus surgery

• Intranasal procedures

The PROFESS™ System, consisting of a computer platform, software and sterile single-use accessories, is designed to enable image guided surgery in intranasal and sinus surgery. Specifically, the system tracks and displays to the surgeon the intraoperative location of navigated surgical instruments, for example suction tools, relative to a CT image. The PROFESS™ System is based on the use of live video images captured by the miniature video camera mounted on the PROFESS™ Navigated Surgical Instruments. The captured images can be processed by the PROFESS™ Software for localization and tracking of the PROFESS™ Navigated Surgical Instrument relative to the PROFESS™ Patient Tracker as long as the PROFESS™ Patient Tracker is partially visible in the video image.

The following are the PROFESS™ System components:

• PROFESS™ Software
• PROFESS™ Navigated Surgical Instruments:
  • PROFESS™ Straight Suction
  • PROFESS™ Curved 70°Suction
  • PROFESS™ Curved 90° Suction
  • PROFESS™ Frontal Sinus Seeker
• PROFESS™ Registration Stickers
• PROFESS™ Patient Tracker
• PROFESS™ Adaptor Cable
• Computer platform containing an SPC-3 Workstation and IO-Tablet, one of:
  • Stryker ADAPT® Platform
  • Stryker Nav3® Platform
  • Stryker Nav3i™ Platform

The provided document describes the Stryker PROFESS™ System, a navigation surgical software module intended for intraoperative guidance in intranasal and sinus computer-assisted surgery. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "No clinical testing has been conducted." (Page 15). The non-clinical testing included "phantom and cadaver tests" for accuracy and "users in cadaver labs" for product validation. However, the exact sample sizes (number of phantoms or cadavers) and their provenance (e.g., country of origin, retrospective/prospective) are not specified for these tests.

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

The document mentions "users in cadaver labs" for product validation, implying medical professionals, but it does not specify the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience").

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

The document does not describe any adjudication method for establishing ground truth in the non-clinical tests.

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 MRMC comparative effectiveness study was conducted. The document explicitly states, "No clinical testing has been conducted." The device is intended as an intraoperative guidance system.

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

The "Accuracy" test (± 2 mm) was performed on "phantom and cadaver tests," which appears to be a standalone measurement of the system's ability to localize instruments relative to CT images. This can be considered a standalone performance assessment of the navigation component.

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

For the accuracy testing, the ground truth was likely established by precise physical measurements in phantom models and cadaver dissections or using highly accurate measurement systems to determine the true position of instruments relative to the CT images. For product validation, "users in cadaver labs" were involved, suggesting practical effectiveness and usability were assessed. However, specific details about "ground truth" other than physical models are not provided.

8. The sample size for the training set

The document does not mention any training set or details about machine learning model development. This submission is for a surgical navigation system, and the provided information focuses on engineering verification and validation, not on AI model training for diagnostic or predictive tasks.

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

As no training set is mentioned (see point 8), this information is not applicable or provided in the document.

Ask a specific question about this device

The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures: - Cranial biopsies - Puncture of abscesses - Craniotomies - Craniectomies - Resection of tumors and other lesions - Removal of foreign objects - Skull base procedures - Transnasal neurosurgical procedures - Transphenoidal pituitary surgery - Shunt placement, including pediatric shunt placement - Placement of electrodes for recording, stimulation and lesion generation - Endoscopic Sinus Surgery (ESS) - Intranasal procedures - Ear implant procedures - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures.

The Stryker Navigation System - CranialMap Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified. The CranialMap Neuro Module is the Stryker Navigation System for cranial surgeries as described in the indications for use statement. The subject device is the Stryker Navigation Software - CranialMap Neuro which together with the Stryker Navigation Platform, Smart Instruments and Accessories forms the Stryker Navigation System - CranialMap Module. It is therefore regarded as a component of the Stryker Navigation System - CranialMap Neuro Module. The design modifications introduced with the Stryker Navigation Software CranialMap Neuro are intended to increase the user comfort, to enhance the look and feel of the software and to simplify and extend the provided functions using the latest system platform technology.

The provided text describes the CranialMap Neuro Module, a navigation surgical software, and its substantial equivalence to a predicate device. However, it does NOT contain the specific details required to answer all parts of your request, especially regarding acceptance criteria derived from a study proving device performance against those criteria.

Here's an breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

What's Available: The document states an "Accuracy Statement" for both the Predicate Device (iNtellect Cranial Software) and the Subject Device (CranialMap Neuro Software). This appears to be a key performance metric.

What's MISSING:

• A formal "acceptance criteria" table explicitly stating quantifiable thresholds the device must meet for various performance metrics.
• A "reported device performance" table that systematically presents the device's actual measured performance against these criteria.
• Other common performance metrics for navigation systems, such as registration accuracy (beyond just RMS display), latency, tracking stability, clinical accuracy in specific scenarios, etc.

Note: The document states that the accuracy statement is "Identical" for both predicate and subject devices. This implies that the CranialMap Neuro Software is expected to meet the same accuracy as the predicate device.

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

What's MISSING: The document explicitly states "No clinical testing has been conducted." (Section 8). It does not describe any specific "test set" in the context of clinical or performance data to validate the algorithm against real patient data. The non-clinical testing refers to "Validation activities, including human factors validation testing" and "system software validation acc, to IEC 62304," but these are general statements about software development processes, not specific studies with sample sizes or data provenance.

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

What's MISSING: Since no clinical testing or a formal test set is described, there's no information about experts used to establish ground truth.

4. Adjudication Method

What's MISSING: No information on adjudication methods, as no specific test set or expert review process is detailed.

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

What's MISSING: No MRMC study is mentioned. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and indications for use, without a comparative effectiveness study involving human readers with/without AI assistance.

6. Standalone (Algorithm Only) Performance

What's Available: The "Accuracy Statement" provided (mean accuracy of 2 mm for translation and 2° for rotation "Within the camera working space") refers to the system's accuracy, which would include the algorithm's contribution to tracking and spatial information computation. This is likely a standalone performance metric for the navigation system.

What's MISSING: Further details on how this "mean accuracy" was measured (e.g., phantom studies, specific methods used).

7. Type of Ground Truth Used

What's MISSING: For the accuracy statement, the document itself does not specify the ground truth mechanism (e.g., direct measurement with a CMM, high-precision phantom, etc.). Given it's a navigation system for surgical guidance, the ground truth for such accuracy measurements typically comes from high-precision physical measurements on phantoms or test setups.

8. Sample Size for the Training Set

What's MISSING: This device is a surgical navigation software module, not primarily an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for image analysis or diagnostics. The software's function is guidance based on predetermined anatomical structures and real-time tracking, not learning from a large dataset to make predictions or classifications. Therefore, the concept of a "training set" as typically understood in AI/ML is not applicable here.

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

What's MISSING: As explained above, the concept of a training set and its ground truth is not applicable in the context of this traditional surgical navigation software.

Summary of the Study (as described in the document):

The "study" presented is primarily a substantial equivalence comparison between the CranialMap Neuro Software (subject device) and the iNtellect Cranial Software (predicate device). This is a regulatory pathway (510(k)) where the manufacturer demonstrates that a new device is as safe and effective as a legally marketed predicate device.

The "study" to meet acceptance criteria, in this context, involves:

• Non-clinical testing: This includes "Validation activities, including human factors validation testing" and "system software validation acc, to IEC 62304 'Medical device software - Software life cycle processes'." These are general statements about software development, quality assurance, and usability.
• Comparison of Technical Characteristics: A detailed table comparing aspects like indications for use, user interface, modes of operation, control mechanisms, operating principle, accuracy statement, registration accuracy, system components, etc. The claim of "Identical" for the accuracy statement (2mm translation, 2° rotation) is central to demonstrating equivalence in this critical performance aspect.

Conclusion:

The provided document details a regulatory submission for substantial equivalence. While it clarifies the intended performance (specifically the stated accuracy), it does not describe a conventional clinical or performance study with detailed acceptance criteria, test sets, expert ground truth, or MRMC studies that would typically be associated with AI/ML-driven diagnostic or prescriptive devices. The "proof" relies on demonstrating that the new device's technological characteristics, including its accuracy, are identical or equivalent to a previously cleared predicate device, along with general software validation activities.

Ask a specific question about this device

The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient.

The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

The Stryker NAV3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k).

The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized.

The NAV3i Platform consists of a mobile cart, a computer system, a monitor and a Navigation Camera. During surgery, the placed close to the operating room table but not within the sterile field. Articulated arms allow for the alignment of the Navigation Camera and the monitor to the operative field. The NAV3i Platform features for entering medical images such as CT images or microscope images which are required for navigation. The computer is used to install and run Stryker Navigation Software. while the monitor conveys navigation information to the user.

The Stryker NAV3i Platform is a computer workstation intended to display patient-specific images/anatomical landmark information and track surgical instruments for stereotactic procedures when used with specific Stryker Navigation surgical software. The non-clinical testing conducted aimed to demonstrate that the device performs as safely and effectively as its predicate device, the Cart I Platform (Stryker Navigation System - ENT Module, K002732).

Here's an analysis of the acceptance criteria and study details provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical testing for a medical device platform. Rather than a test set of patient data, the studies involved various engineering and simulated use tests.

• Accuracy Test: While the document states "All accuracy specifications met with statistical significance," it does not specify the sample size for the accuracy test. It mentions following ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, which would define the methodology for determining accuracy.
• Startup Reliability & Robustness: The document states that "The number of test samples and test runs required to simulate reliability over lifetime was defined using statistical methods." However, specific sample sizes (number of devices, number of runs) are not provided.
• Data Provenance: The studies are non-clinical, involving device testing rather than patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the traditional sense. These would be considered prospective laboratory/engineering tests conducted by the manufacturer.

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

• Since these are non-clinical engineering and usability tests, the concept of "ground truth established by experts" in the clinical imaging sense is not directly applicable.
• User Need Validation and Human Factors Engineering (HFE) would involve user feedback and expert assessment (e.g., human factors engineers, clinical users like surgeons) to validate usability and user needs. However, the number and specific qualifications of any experts involved are not detailed in the summary. It broadly states "Validation successful, all user needs met" and "Validation successful, device safe and effective with respect to use errors."

4. Adjudication Method for the Test Set

Not applicable. The described tests are primarily performance and safety evaluations of the device's technological characteristics, not subjective interpretations requiring 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 explicitly states: "No clinical testing has been conducted."
• This submission focuses on establishing substantial equivalence for a platform based on its technological characteristics and non-clinical performance, not on the clinical effectiveness of specific surgical software or human-AI interaction.

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

Yes, the testing described is primarily standalone device performance (without a human-in-the-loop clinical effectiveness study).
The "Accuracy Test" evaluates the Stryker Navigation System's (including NAV3i Platform, software, instruments) positional accuracy directly, without human interpretation as part of the primary measurement.
"Integration Tests" confirm compatibility and performance of the platform with various software modules in a simulated clinical use, essentially evaluating the combined system's functional integrity.

7. The Type of Ground Truth Used

For the non-clinical tests:

• User Need Validation: Ground truth would be defined by the pre-established user requirements and intended uses of the device.
• Human Factors Engineering: Ground truth relates to established human factors principles and identified potential use errors.
• Safety Test regarding risk analysis: Ground truth is based on the identified risks and the defined effectiveness of risk mitigation measures.
• Product Safety Test regarding medical electrical equipment: Ground truth is the compliance with specific international standards (AAMI/ANSI ES60601-1).
• Accuracy Test: Ground truth for accuracy would be an objectively measured "true" positional reference, as defined by the ASTM F2554-10 standard. This standard outlines methods to measure positional accuracy, typically involving phantoms and known spatial references.
• Integration Tests, Startup Reliability, Robustness, Shipment Test: Ground truth is the device meeting its predefined engineering specifications and functional requirements under various conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware platform for surgical navigation software. The document does not describe any machine learning or AI algorithms requiring a training set in the context of device clearance. The software that runs on the platform is cleared separately.

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

Not applicable, as there is no mention of a training set for machine learning/AI algorithms in this submission for the NAV3i Platform.

Ask a specific question about this device