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Precision Spine Navigation Instrumentation are intended to be used during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Precision Spine Navigation Instrumentation are specifically designed for use with the Medtronic Stealth Station System, 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Precision Spine Navigated Instruments are non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899

The provided text describes a 510(k) premarket notification for "Precision Spine Navigation Instrumentation." It outlines the device's intended use and claims substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria.

Specifically, the document is a regulatory submission rather than a research study report. It discusses the types of performance data collected (accuracy and precision testing per ASTM F2554-10, mating interface assessments, CMM inspection, instrument verification, and simulated use) but does not provide:

• Specific acceptance criteria values.
• Reported device performance values against those criteria.
• Sample sizes for test sets (other than implying "simulated use" was done).
• Provenance of data (country of origin, retrospective/prospective).
• Number or qualifications of experts.
• Adjudication methods.
• Effect sizes for human readers with/without AI assistance (as this is not an AI device).
• Standalone algorithm performance (as this is not an AI device).
• Ground truth types with specifics.
• Sample size for the training set (not applicable as it's not a machine learning device).
• How ground truth for the training set was established (not applicable).

Therefore, I can only provide information based on what is present in the document, which is limited regarding a detailed study demonstrating acceptance criteria.

Based on the provided text, here is what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of computer Assisted Surgical Systems," and that "The accuracy and precision testing...was performed, per ASTM F2554-10." This ASTM standard defines methods for assessing accuracy, but the specific acceptance criteria (e.g., "accuracy must be within X mm") and the reported values achieved by the device are not detailed in this document. Therefore, a table with specific values cannot be created from this text.

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

• Sample Size: Not explicitly stated. The text mentions "The accuracy and precision testing...was performed" and "Simulated Use," implying a test set was used for these activities, but the number of tests or samples is not provided.
• Data Provenance: Not specified.

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

• Not applicable/Not specified. This device is an instrument for navigation, not an AI or diagnostic imaging device that typically requires expert-established ground truth in the same way. The testing mentioned appears to be engineering and performance verification.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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. This device is "Navigation Instrumentation" and not an AI or diagnostic tool. It assists surgeons, but the documentation does not describe an MRMC study or AI assistance.

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

• Not applicable. This is not an algorithm-only device. It is a physical instrument used with an existing navigation system (Medtronic StealthStation System).

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

• For the performance tests mentioned (accuracy, precision, CMM inspection), the "ground truth" would likely be based on established engineering standards, calibration references, and design specifications. For example, CMM inspection measures against CAD models or specified tolerances. "Simulated Use" would likely have predefined successful outcomes. No "expert consensus," "pathology," or "outcomes data" in the diagnostic sense is described.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable.

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The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

The provided text is a 510(k) summary for a medical device (Reform Pedicle Screw System) and does not describe acceptance criteria or a study proving that an AI/device meets acceptance criteria. Instead, it details the indications for use, technical characteristics, and a performance testing summary related to demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of an AI device. The document describes a physical medical device (pedicle screw system) and its regulatory clearance process based on substantial equivalence, not the performance of an AI algorithm against defined acceptance criteria.

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The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, and cross connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ReForm Pedicle Screw System:

Based on the provided 510(k) summary, the device is a ReForm Pedicle Screw System, which is a medical device and not an AI/ML-based diagnostic or imaging device. Therefore, the questions related to AI/ML specific performance evaluation metrics, ground truth establishment for AI/ML models, and training/test set sample sizes in the context of AI/ML are not applicable.

The document describes a traditional medical device submission focusing on substantial equivalence to predicate devices, primarily through engineering analysis.

Description of Acceptance Criteria and Study:

The "acceptance criteria" for this device, in the context of a 510(k) submission, are met by demonstrating substantial equivalence to legally marketed predicate devices. The primary method used to prove this is through performance evaluation based on engineering analysis.

Essentially, the device is "accepted" if it can show that its technological characteristics and performance are comparable to (or do not represent a worst-case scenario compared to) already cleared devices with the same intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by standards such as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. |
| Biocompatibility: Materials used must be biocompatible for implantation. | Materials are standard medical grade alloys (stainless steel, cobalt chromium, titanium/titanium alloy), implying accepted biocompatibility that is equivalent to predicate devices. |
| Fit and Function: New designs and sizes (specifically additional cross connectors) must integrate properly and maintain the intended function of the system. | The purpose of the submission is to make modifications by adding "an additional design and sizes of cross connectors." The engineering analysis confirms these modifications "do not substantially differ from the legally marketed predicate devices." |
| Intended Use: The device must perform effectively for its stated indications. | The intended use and technological features of the modifications/additions "do not substantially differ from the legally marketed predicate devices." The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a range of spinal instabilities and deformities, consistent with the predicates. |

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

• Sample Size: Not applicable in the traditional sense of a clinical or imaging study. The "test set" here refers to the specific modifications (additional design and sizes of cross connectors) and existing components that underwent engineering analysis. The number of physical units or designs tested is not specified but would typically involve a sufficient number to validate mechanical properties.
• Data Provenance: Not applicable. The "data" comes from engineering tests and material specifications, not from patient data or clinical trials.

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)

• This is not applicable for this type of device submission. There is no "ground truth" established by medical experts for a test set in a clinical or diagnostic context. The ground truth for mechanical performance relies on established engineering principles, material science, and regulatory standards. Experts involved would be engineers and material scientists conducting the tests and analyses. Their qualifications are not specified in this document.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation or diagnostic accuracy is being assessed. This submission focuses on engineering equivalence.

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. This is not an AI/ML device, nor is it a diagnostic tool where human readers' performance with/without AI assistance would be relevant.

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

• Not applicable. This is not an algorithm or an AI/ML device.

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

• The "ground truth" in this context refers to established engineering standards, material specifications, and the mechanical performance of the predicate devices. The new device's components are evaluated against these validated benchmarks.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.

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