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The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.

The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools or implants in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge or the Hover-T bridge) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools or implants according to the computerized, image-based, preoperative plan.

The main components of the SpineAssist™ system include:

• A. SpineAssist™ device
• B. Workstation
• A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt (e.g., specific quantitative benchmarks for acceptance, detailed performance metrics with numerical results, sample sizes for test and training sets, expert qualifications, or adjudication methods).

However, based on the summary of non-clinical performance data and conclusions, I can infer the general acceptance criteria and report the mentioned performance.

Here's an analysis of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly suggests that the system's performance for "accuracy" and "safety and effectiveness" during "general spinal surgical procedures" were the key criteria.

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

The document mentions "non-clinical performance data" and lists several "case studies" and "accuracy tests." It does not specify the sample size (e.g., number of cases, number of measurements) for any of these tests.

The data provenance is not explicitly stated. However, given the nature of "non-clinical performance data" for a surgical device involving "accuracy tests" and "case studies," it is highly likely that these were conducted in a controlled laboratory or cadaveric setting, rather than on human patients (since "Clinical Performance Data" is marked as "Not Applicable"). It is likely prospective for the specific tests conducted for this submission. The company is based in Israel, so the studies were likely conducted there or in a partnered facility.

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

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the "accuracy tests" or "case studies."

4. Adjudication Method for the Test Set

The document does not provide any information regarding adjudication methods.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this summary. The device is a surgical navigation system, not an AI diagnostic tool that assists human readers in interpreting medical images. "Clinical Performance Data" is explicitly stated as "Not Applicable," further reinforcing that human reader studies are outside the scope of this submission.

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

Yes, the "Non-Clinical Performance Data" listed are all standalone algorithm/system performance tests. The device itself is designed to guide surgical tools based on algorithmic processing of imaging data, and the tests like "General Spinal Accuracy Test," "Hover-T Accuracy Test," and "New Imaging and Lateral to 30 degree Accuracy Test" directly assess the system's performance in this standalone capacity. The lack of "Clinical Performance Data" and MRMC studies further supports that the reported performance reflects the algorithm/system without human-in-the-loop performance for this specific submission.

7. The Type of Ground Truth Used

While not explicitly stated, for "accuracy tests" in a surgical navigation system, the ground truth would typically be established by:

• Precise measurements using highly accurate calibration tools or coordinate measuring machines in a controlled environment (e.g., phantom, cadaveric models).
• Known physical dimensions or fiducial markers on phantoms or cadavers which the system is attempting to target or guide to.
• For "case studies" (e.g., Osteoid Osteoma, Thoracic Hover-T), the "ground truth" might refer to the actual anatomical position or intended trajectory as confirmed by intra-operative imaging or post-operative assessment against the surgical plan.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set.

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

The document does not provide any information regarding how the ground truth for the training set was established.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:

Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/Pallidotomies.

Spinal Procedures:

Spinal implant procedures, such as pedicle screw placement.

ENT Procedures:

Transphenoidal procedures. Intranasal procedures.

Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies./Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.

Not Found

The provided text is a 510(k) Summary for a device called the StealthStation® System, with a focus on an "Indications Modification." This document describes a change to the intended use of the device rather than a new device or significant technical modification. As such, it relies on previously submitted clinical data and the concept of substantial equivalence, rather than presenting new acceptance criteria or a specific study to prove new performance claims for this particular submission.

Therefore, many of the requested details about acceptance criteria and a new study are not present in this document, as this submission is for an indications modification based on existing data that supported previous clearances.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/provided. This submission is for an indications modification of an existing, cleared device (StealthStation® System). It does not present new performance data or acceptance criteria for a new device or a new performance claim. It relies on the substantial equivalence to previously cleared versions (K954276/K972398/K974187) and the clinical study data originally submitted for K954276.

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

The document states, "A review of clinical study data originally submitted in K954276 was provided to support the claim of substantial equivalence." Since this is a modification to indications for use based on previously submitted data, the details of the sample size and provenance for that original K954276 study are not provided in this specific 510(k) summary.

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

This information is not provided in the current document. It would have been part of the original K954276 submission.

4. Adjudication Method for the Test Set

This information is not provided in the current document. It would have been part of the original K954276 submission.

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

Not applicable/provided. This document focuses on an indications modification based on prior clearance and data. There is no mention of a new MRMC comparative effectiveness study to assess human readers with or without AI assistance. The StealthStation is a navigation system, not an AI-assisted diagnostic tool as typically understood in the context of MRMC studies involving image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The StealthStation is a surgical navigation system, inherently designed for human-in-the-loop performance during surgical procedures. The concept of a "standalone" algorithm performance as typically applied to AI diagnostics is not relevant here.

7. Type of Ground Truth Used

The document mentions that the system aids in "precisely locating anatomical structures... relative to a CT or MR based model or fluoroscopy images of the anatomy." This implies that the ground truth for the original K954276 study would likely be the actual anatomical structures as confirmed by imaging (CT/MR/Fluoroscopy) or direct surgical observation. However, the specific methodology for establishing ground truth from the original study is not detailed in this summary.

8. Sample Size for the Training Set

Not applicable/provided. The StealthStation is a stereotactic instrument/navigation system. The concept of a "training set" as understood in machine learning for an AI-based diagnostic device is not directly applicable to this type of device based on the information provided. While there would have been internal validation during development, it wouldn't typically be described with a "training set" in the context of a 510(k) for an indications modification of a navigation device.

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

Not applicable/provided for the reasons stated in point 8.

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The StealthStation® System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

This submission describes changes made to the StealthStation™ System to include the use of a camera array utilizing two 2-dimensional cameras as an alternative to the originally cleared camera array utilizing three 3-dimensional cameras.

The provided text is a 510(k) summary for a digitizer change to the StealthStation® System, indicating substantial equivalence to a previously cleared device. It does not contain primary study data or explicit acceptance criteria with specific performance metrics as would be found in a detailed clinical or technical study report.

Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics cannot be found in this document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Based on the provided document, the primary "acceptance criterion" is a demonstration of substantial equivalence to the original StealthStation® System (cleared in K954276) despite a change in the digitizer.

Important Note: The specific performance metrics (e.g., accuracy, precision measurements) that were used to demonstrate substantial equivalence are not detailed in this summary. The summary only states that "Performance data was provided to support the claim of substantial equivalence."

Study Information (Based on available text)

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

   • Not provided. The document states "Performance data was provided," but does not specify any sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective.

2. 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 provided. This type of information is not typically found in a 510(k) summary focused on hardware changes for an existing device.

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

   • Not provided.

4. 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/Not done (based on the device type and context). The device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers. The change described is a digitizer hardware change.

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

   • Not applicable in the typical sense of "algorithm only." The "device" is a physical system involving hardware (digitizers) and software for surgical navigation. While its performance would be evaluated as a system, the concept of a "standalone algorithm" in the context of AI without human-in-the-loop doesn't directly apply here. The "performance data" mentioned would likely pertain to the accuracy and reliability of the navigation system's output.

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

   • Not explicitly stated in relation to specific "ground truth" establishment. For a surgical navigation system, "ground truth" would typically relate to known physical measurements, phantom studies, or potentially cadaveric studies with precise fiducial markers. The document does not specify the method used for the "performance data."

7. The sample size for the training set:

   • Not applicable/Not provided. This device is a hardware/software system for surgical navigation, not a machine learning model that undergoes a "training set" in the common sense.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. (See point 7)

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The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The Optical Tracking System (OTS) provides an interactive, image-guided means of localizing targets in surgical procedures. A camera array tracks the position of probes and various tools. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon registration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.

The provided text does not contain the detailed information required to answer all parts of your request. This document is a 510(k) summary for a medical device (Optical Tracking System) and focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study report with specific performance metrics and validation methodologies.

However, I can extract what is available and indicate where information is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The provided document, a 510(k) summary for the Optical Tracking System (OTS), does not explicitly define quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and describes the safety testing performed. The "study" described is primarily internal system and unit testing rather than a formal clinical or controlled comparative performance study to prove specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance thresholds (e.g., "accuracy must be within X mm").

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

• Sample Size for Test Set: Not specified. The document refers to "system and unit testing" but does not give details on the number of cases, images, or tests performed.
• Data Provenance: Not specified. Given it's internal "system and unit testing," it's likely internal simulated or lab data, but no details are provided. It does not mention retrospective or prospective studies.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Missing Information: The document does not describe the involvement of external experts or the process of establishing ground truth for any test sets beyond internal software verification.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

Missing Information: There is no mention of an adjudication process, implying that ground truth was likely established through internal validation/verification methods as part of the software testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's technical functionality and substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

• Standalone Study: Yes, the described "system and unit testing" appears to be a form of standalone performance evaluation. The testing verifies the software's functionality, accuracy of transformations, and spatial accuracy of the digitizer independently. It's essentially an assessment of the algorithm and hardware's technical capabilities.

7. The Type of Ground Truth Used

• Type of Ground Truth: The document implies that ground truth was established through engineered or calculated accuracy standards for software and hardware components. For example, "spatial accuracy of the digitizer" and "accuracy of the transformations" suggest that known inputs were used to verify calculated outputs, rather than clinical ground truth like pathology or expert consensus on patient data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document does not describe a machine learning algorithm that requires a training set in the modern sense. It refers to a "graphical planning tool" and "application software" which are likely rule-based or algorithm-driven rather than learned models.

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

• Ground Truth for Training Set: Not applicable/Not specified, as no training set for a machine learning model is mentioned.

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The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.

This submission is an addendum to K954276 which allows the StealthStation™ to track a powered surgical drill. The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276.

The provided text describes an addendum to an existing 510(k) submission (K954276) for the StealthStation™ Drill Attachment (K974161). This addendum aims to allow the StealthStation™ to track a powered surgical drill.

However, the provided text does not contain enough information to answer many of the specific questions regarding acceptance criteria and a study proving device performance in detail. The document is primarily a regulatory approval letter and a summary of safety and effectiveness for a device addendum, not a detailed study report.

Here's what can be extracted and what cannot:

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

Missing Information:

• The specific quantitative metrics for "substantially equivalent" are not provided (e.g., accuracy, precision tolerances). The document only states that it was shown to be substantially equivalent.
• The actual performance values (e.g., "device achieved tracking accuracy of X mm") are not reported.

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

Missing Information: This information is not present in the provided text. The document refers to "the method used to track other optical probes specified in 510(k) No. K954276," suggesting a comparison, but details of that study or any new study for the drill attachment's tracking ability are absent.

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)

Missing Information: This information is not present in the provided text. No mention is made of human experts establishing ground truth for any test.

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

Missing Information: This information is not present in the provided text. No adjudication method is mentioned, as the nature of the "study" is unclear and focused on technical tracking rather than diagnostic or interpretative tasks.

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

Missing Information: This information is not present in the provided text. The device is a surgical navigation system component, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device's function as described.

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

Likely Applicable Based on Context: Yes, the essence of the "study" mentioned for the StealthStation™ Drill Attachment is a standalone evaluation of its tracking capabilities. The text states: "The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276." This implies a technical performance evaluation of the device itself, independent of a human-in-the-loop scenario.

Missing Information: Specific details of how this standalone performance was measured (e.g., the test setup, measurement equipment, environmental conditions) are not provided.

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

Inferred Ground Truth: For tracking a drill bit of known length, the ground truth would likely be the known physical length of the drill bit and its true spatial position/orientation as measured by a highly accurate external reference system (e.g., a precision optical tracker, coordinate measuring machine) during the test.

Missing Information: Specifics on how this ground truth was established or measured are not provided.

8. The sample size for the training set

Not Applicable/Missing Information: This device involves a tracking system, not a machine learning or AI model in the modern sense that typically requires a separate training set. Even if there were internal calibration/configuration processes, they wouldn't be referred to as a "training set" in the context of an AI/ML device.

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

Not Applicable/Missing Information: As above, a "training set" as understood for AI/ML is not applicable here.

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The Optical Tracking System (OTS) is a graphical planning tool that allows for preoperative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.

Here's a breakdown of the acceptance criteria and study information for the Optical Tracking System (OTS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly states: "The results from the OTS are compared to a phantom with targets of known position."

• Sample Size for Test Set: The text does not specify a numerical sample size for the targets on the phantom. It only mentions "targets of known position."
• Data Provenance: The data is generated through testing with a phantom (a physical model with known properties), not clinical patient data. Therefore, it is a simulated/laboratory setting, not retrospective or prospective clinical data from a specific country.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

The ground truth for this device's performance test is established by the known, pre-defined positions of targets on a phantom. Human experts are not involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

Since the ground truth is established by the known positions on a phantom, there is no need for human adjudication of the test results. The device's measurements are directly compared to these known values.

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

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done.

This submission is for an image-guided surgical planning tool, not an AI diagnostic tool. The performance evaluation focuses on the system's accuracy in tracking and localization, not on changes in human reader performance with or without AI assistance.

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

• Standalone Performance: Yes, a standalone performance evaluation was done.

The reported accuracy of "0.3 mm" for the camera array appears to be a standalone measurement of the system's ability to track positions against a known phantom. While the system is intended for use with a surgeon ("human-in-the-loop"), the verification of its core accuracy is performed independently of a surgeon's interpretation or action, by comparing its output to predefined phantom targets. The statement "RSA Optical Tracking System (OTS) systems testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, it verifies that all target coordinate input and displays are accurate. The results from the OTS are compared to a phantom with targets of known position. The camera array is accurate to a mean value of 0.3 mm. This accuracy is maintained over a period of extended operation" describes a standalone evaluation of the device's technical specifications.

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

• Type of Ground Truth: The ground truth used is based on known, pre-defined positions of targets on a phantom. This is a form of physical/engineering ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information about a training set. This device is described as an "Optical Tracking System," not a machine learning or AI algorithm that would typically require a training set in the modern sense. Its functionality is based on established principles of optical tracking and geometry.

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

• How Ground Truth for Training Set Was Established: Not applicable, as no training set is mentioned or implied for this type of device in the provided text.

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