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The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such, the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon's clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement. The following components are part of the RJB system ((R) = Reusable (SU) = Single Use):

• RJB Device (SU)
• Quick Connect Axial Ratcheting Handle (R)
• Straight Probe (R)
• Duckbill Probe (R)
• Plastic Ratchet Handle (SU)
• Plastic Straight Probe (SU)
• Plastic Duckbill Probe (SU)
• MPV7 (Jamshidi Needle) Bevel Tip 8 Gauge (SU)
• MPV7 (Jamshidi Needle) Diamond Tip 8 Gauge (SU)
• MPV7 (Jamshidi Needle) Bevel Tip 10 Gauge (SU)
• MPV7 (Jamshidi Needle) Diamond Tip 10 Gauge (SU)
• RJB Application

Note, a Tablet Computer is required to operate the device. The Tablet is not provided to the end user.

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The Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation® System S8, which 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

• For a comprehensive summary of indications, the IFU for the specific system of use must be directly referenced: Altus Spine Valencia Pedicle Screw System / Altus Spine Monaco Pedicle Screw System.

The Altus Spine Navigation System is intended to pair with either the Altus Spine Valencia Pedicle Screw System or Altus Spine Monaco Pedicle Screw system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The Altus Spine Navigation system may be used for noncervical pedicle fixation via posterior percutaneous approach with MIS instrumentation.

The Altus Spine Navigation System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Altus Spine Navigation System includes the following instruments dedicated to screw placement: Screwdrivers and Taps. The Altus Spine Navigation System is to be used with the following Altus Spine Systems:

▪ Altus Spine Valencia Pedicle Screw System
▪ Altus Spine Monaco Pedicle Screw System

All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile. The Altus Spine Navigation System instruments are not compatible with implants from other manufacturers. The Altus Spine Navigation System are designed for use only with Medtronic StealthStation® System S8 (V2.1.0) and the Medtronic NavLock® Tracker System.

Based on the provided FDA 510(k) clearance letter for the Altus Spine Navigation System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set (number of instruments tested or number of trials). It only mentions that the Altus Spine Navigation System was "tested side-by-side with the primary predicate device."

Regarding data provenance:

• Country of Origin: Not specified, but implied to be related to Altus Partners, LLC (Pennsylvania, USA) and Medtronic (USA).
• Retrospective or Prospective: The testing described ("tested side-by-side") suggests a prospective performance evaluation conducted specifically for this 510(k) submission.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. The nature of the testing (recognition, location accuracy, dimensional accuracy, and critical length using ASTM F2554) suggests an objective, measurement-based ground truth rather than a subjective expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the objective, measurement-based nature of the performance tests (ASTM F2554, dimensional comparisons), an adjudication process like 2+1 or 3+1 (typically used for subjective assessments by multiple readers) would not be applicable or necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance.

No, an MRMC comparative effectiveness study was not done.

This device (Altus Spine Navigation System) is a set of reusable surgical instruments designed to interface with an existing navigation system (Medtronic StealthStation® System S8). It is not an AI-powered diagnostic software or a device that directly assists "human readers" in interpreting medical images. Therefore, a study comparing human reader performance with and without AI assistance is not relevant to this device's function or clearance.

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

Yes, the performance tests described are essentially "standalone" device performance tests.

The tests evaluated the instruments themselves in their ability to be recognized and tracked accurately by the Medtronic StealthStation® System S8, and their dimensional accuracy. This is a characteristic of the device itself, independent of a specific surgeon's performance or interpretation during a procedure. It's about the technical performance of the physical instruments.

7. The Type of Ground Truth Used

The ground truth used for these performance tests was objective, measurement-based data derived from:

• Standardized Test Methods: Adherence to ASTM F2554 for recognition and location accuracy.
• Physical Measurements: Dimensional accuracy and critical length comparisons.

This is not a ground truth derived from expert consensus, pathology, or outcomes data, as those are typically used for diagnostic or therapeutic devices where subjective interpretation or clinical effect is being assessed.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The Altus Spine Navigation System is a set of physical surgical instruments, not an AI/machine learning algorithm that requires a training set.

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

As the concept of a training set is not applicable, this question is not relevant to the Altus Spine Navigation System.

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The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S7 and StealthStation System S8, which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Innovasis Navigation Instruments are reusable instruments used for the preparation and insertion of Innovasis Pedicle Screw System implants, in either open or percutaneous procedures. These instruments are designed for navigated use with the Medtronic StealthStation. The Innovasis Navigation Instruments include the Vector M-S Navigation Instruments for use with the Vector Pedicle Screw System and the Excella Navigation Instruments for use with the Excella II, Excella 3, and Excella MIS pedicle screws. The Innovasis Navigation Instruments are manufactured from medical grade stainless steels. The purpose of this 510(k) is to add the Vector M-S Navigation Instruments to the system.

The provided text from the FDA 510(k) summary (K250182) for "Innovasis Navigation Instruments" contains information required to answer some of the questions. However, critically, this submission focuses on a medical device (navigational instruments) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical "acceptance criteria" and "study types" associated with AI/SaMD performance evaluation (such as sensitivity, specificity, MRMC studies, ground truth establishment for algorithms, training sets, etc.) are not applicable and not detailed in this document.

The study described here is primarily an engineering analysis and geometric comparison to predicate devices, along with a validation of navigation compatibility. It does not involve AI performance evaluation or clinical outcomes in the way an AI/SaMD submission would.

Here's an attempt to answer the questions based on the provided text, while explicitly noting what information is not present or applicable.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This device is not an AI/Software as a Medical Device (SaMD). The acceptance criteria and studies described are for physical surgical navigation instruments, not for an algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical instrument, the "acceptance criteria" are related to its design, materials, and compatibility, rather than performance metrics like sensitivity or specificity.

• Indications for Use are identical to predicate.
• Manufacturing and Biocompatibility are identical to predicate.
• Instrument Types and Sizes are identical to predicate.
• Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry) are identical to predicate.
• Sterility is identical to predicate. | "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates: Principles of Operation, Indications for Use, Manufacturing and Biocompatibility, Instrument Types and Sizes, Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry), and Sterility." |
  | Navigation Compatibility | - Compatibility with Medtronic StealthStation™ System S7 and S8. | "A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System S7 and S8."
  "The results show that the subject device is substantially equivalent to cleared predicated." |
  | Mechanical Performance | - Overall mechanical performance is equivalent to predicate devices. | "The overall technology characteristics and mechanical performance data lead to the conclusion that the Innovasis Navigation Instruments are substantially equivalent to the predicate device." |

Note: The text explicitly states, "The Innovasis Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to the predicate devices." This implies that the 'performance' is largely demonstrated by meeting design specifications and showing equivalence to existing, cleared devices.

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

• Sample Size for Test Set: Not applicable or not specified in the context of an AI/SaMD test set. The evaluation was an "engineering analysis and geometric comparison" and "validation." This suggests testing of instrument prototypes or production samples, but there is no "test set" of patient data as would be used for AI/SaMD.
• Data Provenance: Not applicable in the context of patient data. The evaluation is on the manufactured instruments themselves.

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

• Number of Experts: Not applicable. Ground truth, in the AI/SaMD sense (e.g., image annotations, disease labels), is not established for this type of device submission. The "ground truth" here is the design specification and the functionality of the predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation or labeling of data that would require adjudication.

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 Study: No. This is not an AI/SaMD and therefore an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

• Standalone Performance: No. This is a physical medical instrument, not an algorithm.

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

• Type of Ground Truth: For this device, the "ground truth" is primarily based on design specifications, engineering principles, and the established safety and effectiveness of the predicate devices. The "validation" would confirm that the instruments correctly interface and function with the Medtronic StealthStation System. There is no "disease ground truth" derived from expert consensus, pathology, or outcomes data in this submission.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/SaMD, so there is no training set for an algorithm.

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided FDA 510(k) pertains to physical "Innovasis Navigation Instruments" for spinal surgery, which are Class II devices. The regulatory pathway relies on demonstrating substantial equivalence to predicate devices through engineering analysis, geometric comparison, and compatibility validation, rather than the performance metrics and study designs typically associated with AI/Software as a Medical Device (SaMD) clearances.

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The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such, the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon's clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement. The following components are part of the RJB system:
• RJB Device
• Quick Connect Axial Ratcheting Handle
• Straight Probe
• Duckbill Probe
• RJB Application
Note, a Tablet Computer is required to operate the device. The Tablet is not provided to the end user.

The provided text describes a 510(k) premarket notification for the Ruthless Spine RJB device. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria and results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

The document explicitly states:

• "The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed." (Page 3, 5)
• "Performance Testing - Non-Clinical: There were no changes to the design, intended use, or principles of operation. Therefore, performance testing was not required. The predicate device performance data is applicable to the subject device." (Page 7)
• "Performance Testing - Clinical: Clinical testing was not applicable to support a substantial equivalence determination for the subject device." (Page 7)

This means the submission relies on the prior clearance of the predicate device (DEN230012 – Ruthless Spine RJB) and argues that since there are "no changes to the design, intended use, or principles of operation" (the only modification mentioned being the change of instruments from single-use disposable to reusable), no new performance data is needed for this specific 510(k) submission.

To answer your request, one would need the performance data and study details for the predicate device (Ruthless Spine RJB DEN230012). This document does not contain that information.

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The SOLACE Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including degenerative sacroiliac joint disruptions
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The SOLACE Sacroiliac Fixation System is also indicated for fracture fixation of acute, and nontraumatic fractures involving the sacroiliac joint.

The SOLACE Sacroiliac Fixation System Navigation Instruments are intended to be used with the SOLACE Sacrolliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The SOLACE Sacroiliac Fixation System consists of 3D printed medical grate Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The SOLACE implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

This document is a 510(k) summary for the SOLACE Sacroiliac Fixation System, a medical device for sacroiliac joint fusion and fracture fixation. It does not contain information about software or AI. Therefore, I cannot extract information related to acceptance criteria, study details, human-in-the-loop performance, or training/test set specifics for an AI/software device.

The document discusses the substantial equivalence of the device to previously cleared predicate devices, focusing on the addition of nano claims related to the implant's surface. The studies mentioned are primarily related to assessing the nano-surface features and their in vitro biological responses, not related to an AI/software's performance.

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The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

The Ruthless Spine RJB device ("RJB device") is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such. the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon's clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement.

Here's a breakdown of the acceptance criteria and the studies conducted for the Ruthless Spine RJB device, based on the provided text:

Acceptance Criteria and Reported Device Performance

• RJB device fit securely: 5 (Avg Score)
• Battery pull tab easy to remove: 5 (Avg Score)
• Easy to pair: 5 (Avg Score)
• Four RJB devices able to pair: Yes: 13, No: 1
• Angles updated in real-time: Yes: 14, No: 1
• Accuracy of RJB is ±3.5 degrees: 4.9 (Avg Score)
• Well-integrated features: 4.9 (Avg Score)
• Most people would learn to use quickly: 4.7 (Avg Score) |
  | General Special Controls | - Non-clinical performance data demonstrates device performs as intended.
• Usability testing demonstrates correct use based on IFU.
• Biocompatibility demonstrated.
• Sterility and shelf life supported by performance testing.
• Software V&V and hazard analysis performed.
• Electrical safety, EMC, wireless coexistence demonstrated.
• Labeling includes required information. | The document states that all these special controls were met through various tests (Biocompatibility, EMC/Electrical Safety, Software V&V, Packaging/Sterilization/Shelf Life) and through the content of the device labeling. The "CONCLUSION" states that the De Novo request is granted. |

Study Details

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

• Angle Measurement Accuracy:
  • Test Set Sample Size: Not explicitly stated how many individual measurements were taken, but the results ($0.36 \pm 0.32^\circ$ for axial, $0.74 \pm 0.47^\circ$ for sagittal) suggest multiple readings. The comparison was against a "NIST-traceable calibrated digital protractor."
  • Data Provenance: Bench test, likely conducted in a controlled laboratory environment. No country of origin mentioned, but implied to be internal testing by the manufacturer (Ruthless Spine, LLC, based in Irwindale, CA, USA). Retrospective.
• Procedural Accuracy Testing:
  • Test Set Sample Size: 240 trials (3 measurements at each of 5 levels for 16 surgeon users).
  • Data Provenance: Simulated use conditions, described as the user positioning the RJB instrument against a cadaver pedicle. This indicates a controlled lab setting, not human clinical data. Retrospective.
• Usability Testing:
  • Test Set Sample Size: 16 surgeon users.
  • Data Provenance: Simulated use conditions involving surgeon evaluation. Retrospective.

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

• Angle Measurement Accuracy: The ground truth was established by a "NIST-traceable calibrated digital protractor." This is a metrological standard, not human experts.
• Procedural Accuracy Testing:
  • Ground Truth: "Ground-truth measurement (gravity)" derived from fluoroscopic and photographic images taken when the instrument was positioned against a cadaver pedicle at a "pre-planned axial angle from MRI imaging and sagittal angle from fluoroscopy imaging." One could infer that the pre-planned angles themselves were established by experts interpreting MRI/fluoroscopy, but this is not explicitly stated. The final comparison is to the "gravity," implying the ideal sensor reading.
  • Experts: 16 "surgeon users" participated in positioning the instrument, but their role was as test subjects operating the device, not establishing the ground truth for the device's accuracy output.
• Usability Testing:
  • Experts: 16 surgeons.
  • Qualifications: Referred to as "surgeons representing potential clinical users." No specific years of experience or subspecialty are given.

4. Adjudication Method for the Test Set

• Angle Measurement Accuracy: No human adjudication method; direct comparison to a calibrated instrument.
• Procedural Accuracy Testing: No explicit human adjudication method for the final composite angle error. The error was calculated by comparing the device's measured composite angle to the "ground-truth measurement (gravity)" derived from imaging.
• Usability Testing: Surgeon feedback was captured via a questionnaire, with "Avg Score/Summary" indicating aggregation of individual surgeon responses, but not an adjudication process among experts to resolve discrepancies in truth.

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

• No, an MRMC comparative effectiveness study was not explicitly described.
• The studies focused on the intrinsic accuracy and usability of the device itself in simulated settings, not on how the device improves human reader performance in a clinical decision-making context.
• The "Indications for Use" and "Limitations" sections explicitly state: "No clinical benefit has been demonstrated or is claimed," and "The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation."

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

• Yes, standalone performance was assessed. The "Angle Measurement Accuracy" test directly assessed the device's (RJB's) ability to measure angles against a calibrated protractor, independent of human interaction beyond initial setup.
• The "procedural accuracy testing" involved surgeons in a simulated-use environment, but the measurement itself is the algorithm's output compared to a ground truth, rather than measuring human decision-making with or without the algorithm.

7. Type of Ground Truth Used

• Angle Measurement Accuracy: NIST-traceable calibrated digital protractor (metrological standard).
• Procedural Accuracy Testing: "Ground-truth measurement (gravity)" calculated from fluoroscopic and photographic images of the instrument positioned against a cadaver pedicle at pre-planned angles (derived from MRI/fluoroscopy).
• Usability Testing: Surgeon subjective feedback via questionnaire.

8. Sample Size for the Training Set

• The document describes the device's firmware and app software as "programmed firmware" and "software." It refers to "Software verification testing" and "Verification Testing" to confirm the system functions as designed.
• No information is provided regarding a training set sample size. This suggests that the device's core functionality (measuring angles using an accelerometer and displaying them) is based on deterministic algorithms and physics, rather than machine learning models that require training data.

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

• Since there's no indication of a machine learning-based training set, this question is not applicable to the information provided. The device's operation relies on physical principles (accelerometer, trigonometry) and programmed logic, not learned patterns from a training dataset.

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The surgical instruments are specifically designed for use with the Pulse System, which enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate.

When used with a Pulse Navigation system, the patient reference hardware is intended to provide a reference to a rigid anatomical structure that can be identified relative to the acquired image of the anatomy.

The subject NuVasive Rod Registration Frame is introducing modifications based on the design of existing patient reference hardware, the Spinous Process Clamp (Pulse System K210574). The Rod Registration Frame was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option for attaching the existing Patient Reference Array to the patient. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device Rod Registration Frame is substantially equivalent to the predicate as demonstrated by verification and validation testing performed using well established and previously cleared test methods.

The NuVasive Rod Registration Frame is a surgical instrument designed for use with the Pulse System, enabling computer-assisted navigation for spinal surgical procedures. The device provides a reference to a rigid anatomical structure that can be identified relative to an acquired image of the anatomy when used with a Pulse Navigation system. The device is a modification of an existing patient reference hardware (Spinous Process Clamp, K210574), with updated distal and proximal connection features and removal of radiographic markers (as it is used only for non-fiducial registration).

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes non-clinical testing to demonstrate substantial equivalence, rather than a direct table of specific numerical acceptance criteria and performance for a new, independent claim of efficacy. The core acceptance criterion is that the Rod Registration Frame performs equivalently to its predicate device (Spinous Process Clamp K210574).

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

• The document states that "non-clinical testing was performed." However, it does not specify the sample size for the test sets used in System Level Accuracy Testing, Cadaver Verification, Design Validation, Tolerance Analysis, or Usability Validation.
• The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated in this summary. Given that it's non-clinical testing for a U.S. FDA submission, it's highly probable the testing was conducted in a controlled lab environment and likely within the U.S. or by a recognized testing facility.

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

• This information is not provided in the summary. For non-clinical performance testing of a medical device, ground truth is typically established through engineering measurements, biomechanical modeling, and cadaveric studies where anatomical landmarks might serve as a reference. The "design validation" and "cadaver verification" sections imply that expert evaluation (e.g., of surgical applicability) would have been involved, but details on their number or qualifications are not given.

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

• This information is not provided as the testing described is non-clinical performance and validation testing, not a clinical study involving human reader assessments requiring adjudication.

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 study was done. The device (Rod Registration Frame) is a physical surgical instrument used for navigation, not an AI or imaging diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable. The document explicitly states: "No clinical studies were conducted."

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

• This question is not applicable as the device is a physical surgical instrument, not an algorithm or AI system.

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

• For the performance data mentioned (System Level Accuracy, Design Validation, Tolerance Analysis), the ground truth would be based on engineering specifications, physical measurements, and established performance criteria for navigation devices.
• For Cadaver Verification, the ground truth would involve anatomical landmarks and verified instrument placement/registration accuracy against known anatomical points. This would likely involve precise measurement tools and potentially expert anatomical assessment.

8. The sample size for the training set:

• This question is not applicable as the device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms.

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

• This question is not applicable for the same reason as point 8.

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The Smith & Nephew SURESHOT ™ Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT ™ Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Subject of this premarket notification are modifications to the SURESHOT™ Targeting System to include software updates (V4.0) to include the ability to target for the TRIGEN META-TAN Nail (previously cleared in K092748), the ability for on screen rotation using the SURESHOT™ Targeter, additional languages of the graphical user interface (for international users), updates to the graphical user interface, and updates to the Launcher program

The SURESHOT™ Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in locating and positioning screws in an intramedullary nail implant during orthopedic trauma surgery. The link between the sterile surgical area (patient) and the instrument system is provided through an electromagnetic tracking system. Electromagnetic spatial measurement systems determine the location of instruments that are embedded with sensor coils. When the sensor-embedded instrument is placed inside controlled, varying magnetic fields, voltages are induced in the sensor coils. These induced voltages are used by the measurement system to calculate a 3D virtual position of the instrument. Because the magnetic fields are of low field strength and can safely pass through human tissue, location measurement of an object is possible without the line-of-sight constraints of an optical spatial measurement system that requires a camera.

The SURESHOT™ Distal Targeting System software is intended to be used with existing Smith & Nephew platform, instruments and implants. No new instruments or implants are being cleared via this premarket notification.

The provided text describes a 510(k) premarket notification for the Smith & Nephew SURESHOT™ Distal Targeting System V4.0. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against specific targets.

However, I can extract information related to software validation and verification testing, which serves as the basis for demonstrating the device works as intended.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance metrics (e.g., accuracy in mm, failure rate thresholds). Instead, it states that "Software verification and validation testing was completed in line with FDA's guidance document entitled, 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff,' dated January 11, 2002."

The acceptance criteria are implicitly met if the listed preclinical tests passed, demonstrating that the "software will perform as intended." The reported performance is that "there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended as compared to the predicate."

Implicit Acceptance Criteria (based on tests performed):

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

The document does not specify a "test set" in terms of subject or case count for the preclinical testing. The tests listed are functional and technical software validation tests, typically performed in a controlled environment. Clinical data was explicitly not used or needed to support the safety and effectiveness of the subject device for this 510(k) submission. Therefore, there's no data provenance in the context of clinical studies (e.g., country of origin, retrospective/prospective).

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

Not applicable. The preclinical software tests described do not involve human expert adjudication of medical images or diagnoses to establish a "ground truth." The ground truth for these tests would be the intended software behavior and calculation correctness as defined by engineering specifications.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication for medical data is described. The "adjudication" for software testing would be the engineering team verifying that the test results match the expected outcomes.

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: "Clinical data was not needed to support the safety and effectiveness of the subject device." The submission relies on demonstrating substantial equivalence to a predicate device and software verification/validation.

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

The listed preclinical tests are essentially standalone algorithm/software verification, focusing on the functionality and calculations of the device's software. The device itself (SURESHOT™ Distal Targeting System) is an "intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool to aid the surgeon with drill positioning," implying a human-in-the-loop during actual clinical use. However, the testing described is of the underlying software's performance (e.g., targeting calculations, GUI functionality) in a controlled environment, which can be considered standalone verification of the software components.

7. The Type of Ground Truth Used

For the software validation and verification, the "ground truth" is likely defined by:

• Design specifications: The intended behavior, outputs, and calculations as per the software design documents.
• Known correct values: For calculations (e.g., "Targeting Calculations META"), the ground truth would be precise, pre-calculated results for a given input.
• Previous versions' behavior: For regression testing, the ground truth is the expected behavior of the existing features from prior, cleared versions.

8. The Sample Size for the Training Set

Not applicable. The text describes software updates to an existing system and verification/validation testing. This is not a machine learning model, so there is no training set in the typical sense.

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

Not applicable, as there is no training set for a machine learning model described.

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The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).

The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are reusable conventional manual orthopedic surgical instruments modified with a navigation adapter for use with the BrainLAB VectorVision® Hip Image Guided Surgery System.

This 510(k) submission for the "Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications" does not include any clinical trial data or performance studies to demonstrate its acceptance criteria or device performance.

The submission explicitly states:

• "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
• "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria because the provided document indicates no such clinical study was performed or submitted. The device received substantial equivalence based on non-clinical testing and comparison to legally marketed predicate devices with "similar technological characteristics."

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Zimmer Ortho Guidance Systems Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to:

Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization or Repair of Pelvic/Femoral Fractures

The Zimmer Ortho Guidance Hip Instruments are orthopaedic manual instruments modified to accept a Medtronic Image Guidance System array and are to be used with the Medtronic StealthStation® System.

This document describes the Zimmer Ortho Guidance™ Systems – Hip Instruments. Based on the provided text, the device is an accessory to Image Guided Surgery systems.

Here's an analysis of the provided information, specifically addressing the requested points:

1. Table of acceptance criteria and the reported device performance
   The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision values) or report specific performance metrics for the Zimmer Ortho Guidance™ Systems – Hip Instruments. It states: "No guidance documents exist for these instruments. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." This implies that the validation focuses on compliance with Quality System Regulations (QSR) rather than direct performance measurement against pre-defined acceptance criteria for the instruments' clinical function.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   No test set details are provided. The document explicitly states: "Clinical data and conclusions were not needed for this devices."

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, as no clinical or performance testing data is presented, and no ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable, as no clinical or performance testing data is presented.

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. The device described is an orthopaedic instrument, not an AI-powered diagnostic or assistive tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   Not applicable, as this is an instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable, as no clinical or performance testing data is presented that would require ground truth.

8. The sample size for the training set
   Not applicable, as this is an instrument and not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established
   Not applicable, as this is an instrument and not a machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided document, there was no clinical study or specific performance study conducted to "prove the device meets acceptance criteria" in terms of clinical effectiveness or diagnostic performance. The submission for the Zimmer Ortho Guidance™ Systems – Hip Instruments was a 510(k) premarket notification. The review concluded that the device is "substantially equivalent" to a legally marketed predicate device (Catheter Introducer for the StealthStation System manufactured by Medtronic Surgical Navigation, K022126).

The document states:

• "No guidance documents exist for these instruments."
• "QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." (This refers to manufacturing and quality control, not clinical performance.)
• "Clinical data and conclusions were not needed for this devices."

Therefore, the "study" that proves the device meets acceptance criteria in the context of this 510(k) submission is the demonstration of substantial equivalence to a predicate device, as determined by the FDA, without the need for new clinical performance data for the instruments themselves. The acceptance criteria were primarily met through the regulatory pathway of substantial equivalence based on device description and intended use, rather than a novel performance study.

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