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The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments 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 disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; 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.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.

The provided text is a 510(k) summary for the Reform Pedicle Screw System. This document focuses on the mechanical testing and equivalence of a medical device, specifically a pedicle screw system, rather than a diagnostic AI/ML device that would have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC).

Therefore, the typical acceptance criteria and study design elements you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) for an AI/ML device are not applicable to this submission.

Instead, the performance data provided is entirely about mechanical and material testing to demonstrate the physical characteristics and safety of the implanted device.

Here's a breakdown of the relevant information from the provided text, framed within the context of a traditional medical device submission, recognizing that it doesn't fit the AI/ML paradigm:

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

The document describes performance testing rather than specific acceptance criteria in a tabular format with quantitative metrics for a pass/fail. However, it states the following tests were conducted:

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

• Sample Size: Not specified in the summary. For mechanical testing, this would typically involve a specific number of test articles (e.g., screws, constructs) for each test.
• Data Provenance: The "study" is non-clinical mechanical bench testing performed according to ASTM standards. It's not human-centric data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

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

• Not applicable. Ground truth in this context is established by engineering specifications, standard ASTM testing methodologies, and objective mechanical measurements. It does not involve expert readers reviewing images or clinical data.

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

• Not applicable. Adjudication is relevant for subjective expert reviews, not for objective mechanical testing.

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 a physical implant, not an AI-powered diagnostic tool. MRMC studies are used to evaluate the diagnostic performance of AI or imaging modalities.

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

• Not applicable. There is no algorithm or AI component in this device. The testing is entirely for the physical device's characteristics.

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

• The "ground truth" for this type of device is established by engineering standards and physical test methodologies (e.g., ASTM F1717 for spinal implant constructs). The performance is measured against these established standards and compared to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning; therefore, there is no training set.

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

• Not applicable. There is no training set for this type of device.

In summary, the provided document details the substantial equivalence of a physical medical implant through mechanical testing, not the performance claims or evaluation of an AI-powered diagnostic device.

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Precision Spine S-COMP Reform® POCT Navigated Instruments are indicated for use during the preparation and placement of Precision Spine Reform® POCT Polyaxial Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated instruments are reusable and are specifically designed for use with the Medtronic StealthStation® 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the S-COMP Reform® POCT Navigated Instruments with the Medtronic StealthStation® System is limited to use with the Reform® POCT Spinal Fixation System when the correct Infinity™ tool cards are selected.

The S-COMP Reform® POCT Navigation Instruments are non-sterile, re-usable surgical instruments made from stainless steel. These instruments are designed to interact with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to add instruments to the previously cleared Precision Spine Navigation Instrumentation set to offer compatibility with the Reform® POCT System.

The provided document is a 510(k) premarket notification for the Precision Spine S-COMP Reform® POCT Navigated Instruments. It asserts substantial equivalence to predicate devices based on engineering analysis and geometric comparison, rather than a clinical study with acceptance criteria.

Therefore, many of the requested details, such as specific acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC study details, are not applicable or not available in this type of submission.

Here's a breakdown of the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific performance metrics (e.g., accuracy in mm). The submission relies on "engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
• Reported Device Performance: "The results of the engineering analysis show that the subject is substantially equivalent to the cleared predicates." This implies that the device is expected to perform comparably to the predicate devices, which are already considered safe and effective for their intended use. Specific numerical performance data is not provided.

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

• Sample Size: Not applicable. No test set of cases (e.g., patient images or surgical data) was used for evaluating software performance. The evaluation was based on engineering analysis and geometric comparison of the instruments themselves.
• Data Provenance: Not applicable, as there was no data set for performance evaluation in the traditional sense.

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

• Number of Experts: Not applicable. Ground truth was not established by experts on a test set of data.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was used.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device characteristics and engineering analysis, not reader performance with or without AI assistance. The device is a surgical instrument, not an AI software.

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

• Standalone Performance: Not applicable. The device is a physical surgical instrument intended to be used with a navigation system and by a surgeon. It is not an algorithm that performs actions standalone.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of clinical performance data. The "truth" in this submission relies on the established safety and efficacy of the predicate devices and the engineering analysis demonstrating that the new instruments are geometrically similar and function comparably.

8. The Sample Size for the Training Set

• Training Set Size: Not applicable. This is not an AI/ML algorithm that requires a training set. The device is a physical surgical instrument.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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The E-GPS Navigated Instruments are indicated for use 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. The E-GPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for use as an aid for precisely locating anatomical structures and for the special positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).

Precision Spine E-GPS Navigated Instruments are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "E-GPS Navigated Instruments."

Important Note: The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report for an AI/ML medical device. As such, much of the requested information (especially regarding AI-specific criteria, human reader studies, and large-scale data sets typically associated with AI/ML performance validation) is not present in this document.

The document describes a medical device, the "E-GPS Navigated Instruments," which are reusable surgical instruments designed to work with a robotic navigation platform. This is a mechanical device, not an AI/ML algorithm. Therefore, the acceptance criteria and study described are for a traditional medical device, primarily related to its mechanical and functional compatibility.

Acceptance Criteria and Study for "E-GPS Navigated Instruments"

Given that this is a mechanical instrument and not an AI/ML algorithm, the requested information elements related to AI/ML performance, ground truth establishment for large datasets, and reader studies are not applicable or provided. The "study" here refers to a performance evaluation for a mechanical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The evaluation was based on an "engineering analysis and geometric comparison" to predicate devices. This indicates that the "test set" was not a collection of patient data or images, but rather the design specifications, material properties, and physical dimensions of the E-GPS Navigated Instruments and their predicate counterparts.
• Sample Size: Not applicable in the traditional sense of patient data. It's an analysis of the device itself and its interaction with the robotic platform.
• Data Provenance: Not applicable. This is not a study derived from patient data.

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

• Number of Experts: Not applicable. Ground truth, in the context of an engineering analysis of a mechanical device for substantial equivalence, is established through compliance with engineering standards, material specifications, and comparison to validated predicate device designs.
• Qualifications of Experts: N/A for this type of evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation of data for consensus.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is not an AI algorithm that would assist human readers in interpreting medical images. It's a surgical instrument.
• Effect Size: Not applicable.

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

• Standalone Performance: No, this is not an algorithm. The "performance" described is the device's functional integrity and compatibility with a robotic system and screws, proven by engineering analysis.

7. The Type of Ground Truth Used

• Ground Truth Type: For this 510(k), the "ground truth" for demonstrating substantial equivalence is established through:
  • Engineering specifications and standards: Compliance with ASTM F899 for materials.
  • Comparison to legally marketed predicate devices: The functional and design characteristics of the E-GPS Navigated Instruments were compared to the Globus Medical Excelsius GPS™ (K171651) for the main robotic platform compatibility and Precision Spine's Reform Pedicle Screw System (K200303) and Reform® Midline Cortical Screw System (K173130) for screw system compatibility. The "ground truth" is that these predicate devices are already deemed safe and effective by the FDA, and the new device being sufficiently similar implies equivalent safety and effectiveness.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

• Ground Truth Establishment for Training Set: Not applicable. There is no training set for this mechanical device.

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The Dakota ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Dakota ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Dakota ALIF System is a stand-alone system intended to be used with the bone screws provided. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA for use in the lumbar spine.

The Dakota ALIF System consists of cages in various widths, heights, and lordoses to accommodate individual patient anatomy and graft material size and bone screws. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Dakota ALIF System cages are medical grade PEEK (per ASTM F2026) with tantalum (per ASTM F560) markers and titanium alloy Ti-6Al-4V (per ASTM F136 or ISO 5832-3) integrated fixation screws and screw backout prevention plates. The cages are provided non-sterile.

I'm sorry, but the provided text from the FDA 510(k) clearance letter for the Dakota ALIF System does not contain the specific information required to address your request.

The document is a regulatory clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions performance data related to mechanical testing of the implant (e.g., static and dynamic axial compression, compression shear, subsidence, screw-backout testing) to show that the implant's strength is sufficient for its intended use.

However, it does not include information about:

1. Acceptance criteria and reported device performance (in a table) that would typically be associated with an AI/ML medical device. This device is a physical intervertebral body fusion device, not an AI/ML-driven diagnostic or therapeutic tool.
2. Sample size used for a test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as these concepts are relevant to the validation of AI/ML algorithms, not to the mechanical testing of a surgical implant.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

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The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosy, scollosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The AccuFit® Lateral 2-Hole Plate consists of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) rigid plates and screws of varying sizes. The plate attaches by means of screws to the lateral portion of the vertebral body. The AccuFit® Lateral 2-Hole Plate (Subject Device) will be implanted using the instruments cleared with the AccuFit® Lateral Plate System (K162211), however a new inserter and tray will be introduced to the system that is to be used with the AccuFit® Lateral 2-Hole Plate (Subject Device). The AccuFit® Lateral 2-Hole Plate is to be provided non-sterile. They require sterilization prior to use.

The provided text describes a medical device (AccuFit® Lateral 2-Hole Plate) and its 510(k) clearance by the FDA based on substantial equivalence to predicate devices. It does not present information related to the performance of an AI/ML-enabled device, nor does it detail a study involving human readers or expert ground truth establishment for a diagnostic algorithm.

Therefore, I cannot extract the information required in your request about acceptance criteria, device performance, sample sizes, ground truth establishment, or human reader studies. The document pertains to a physical spinal implant, not an AI-based diagnostic tool.

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The ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.

The ShurFit Lumbar Interbody System (ALIF, LLIF, TLIF, T-PLIF and PLIF Systems) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenous autograft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The ShurFit® Lumbar Interbody System consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy and graft material size. The ShurFit® Lumbar Interbody System implants are offered as PLIF (straight), T-PLIF (oblique), TLIF (curved). ALIF. and LLIF. The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured either from additive Ti-6Al-4V ELI per ASTM F3001 or from medical grade polyetheretherketone (PEEK Optima, LT1) per ASTM F2026 with or without a coating of Commercially Pure Titanium per ASTM F1580 and Hydroxyapatite per ASTM F1185. PEEK implants contain tantalum markers per ASTM F560. The PEEK implants are provided non-sterile with sterilization instructions; the titanium alloy and the PEEK coated implants are provided sterile.

The provided text is a 510(k) summary for the ShurFit® Lumbar Interbody System, a medical device for spinal fusion. This type of regulatory document is typically focused on demonstrating substantial equivalence to already-marketed predicate devices, rather than an AI-powered device undergoing a new type of clinical study for performance in diagnostic or prognostic tasks.

Therefore, the text does not contain any information regarding:

• Acceptance criteria and reported device performance for an AI system.
• Sample size for a test set or its provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone AI performance study.
• Type of ground truth used for AI studies.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the performance data section describes non-clinical testing relevant to the mechanical properties of an implantable spinal device:

• Static and dynamic axial compression per ASTM F2077
• Static and dynamic compression shear per ASTM F2077
• Subsidence per ASTM F2267

The conclusion states that "The results of this non-clinical testing show that the strength of the ShurFit® Lumbar Interbody System Implants is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This refers to physical, mechanical performance of an orthopedic implant, not to the performance of a diagnostic or prognostic algorithm.

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The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Dakota ALIF Plate System consists of a series of plates and screw sizes, along with the necessary surgical instrumentation. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) to provide stabilization and permit spinal fusion to occur. All components are made from Ti-6Al-4V per ASTM F136 or ISO and 5832-3. The products are supplied clean and non-sterile.

The provided text is a 510(k) summary for the Dakota ALIF Plate System, a spinal intervertebral body fixation orthosis. This document does not describe an AI/ML medical device and therefore does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML product.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, typical for a traditional medical device like a spinal implant.

Specifically, it details:

1. Product Name: Dakota ALIF Plate System
2. Regulation Number and Name: 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis
3. Regulatory Class: Class II
4. Product Code: KWQ
5. Indications for Use: Provides an anteriorly placed supplemental fixation for anterior lumbar (L1-S1) fixation for various conditions (degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, pseudoarthrosis, failed previous fusion).
6. Materials: Ti-6Al-4V per ASTM F136 or ISO 5832-3.
7. Predicate Devices: K091044 (Spinal USA Anterior Lumbar Plate System) and K080429 (PYRAMID® +4 Anterior Lumbar Plate System).
8. Performance Data: States that the device was tested per ASTM F1717 for Static Compression Bending, Static Torsion, and Dynamic Compression Bending.
9. Conclusion: The device is substantially equivalent to the predicate device based on overall technology characteristics and mechanical performance data.

Therefore, it is impossible to answer the user's request based on the provided document as it does not pertain to an AI/ML device.

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The NexGen Standalone ACDF System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The NexGen implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

The NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. NexGen Interbody devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior titanium portion of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All implantable components are made from medical grade polyetheretherketone (PEEK), tantalum, and titanium or titanium alloy as described by such standards as ASTM F2026, ASTM F560, and ASTM F136/ISO 5832-3. The products are supplied clean and non-sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the "NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System." It is a regulatory clearance document, not a study report that details acceptance criteria and device performance in the way requested for an AI/ML medical device.

Therefore, I cannot provide the requested information as the document does not contain details about:

• A table of acceptance criteria and reported device performance related to a study proving the device meets acceptance criteria (as would be seen for an AI/ML device validating its performance metrics like sensitivty/specificity). Instead, the performance data cited is for mechanical testing of an orthopedic implant.
• Sample sizes for a test set or training set for AI/ML.
• Data provenance, expert qualifications, or adjudication methods for ground truth, as these relate to the assessment of an AI's diagnostic or predictive capabilities.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance.
• Type of ground truth used in the context of an AI/ML study (e.g., expert consensus, pathology, outcomes data).

The "Performance Data" section in the document refers to mechanical performance testing (e.g., static and dynamic axial compression, compression shear, torsion, subsidence) against ASTM standards, which are entirely different from the performance metrics and study methodologies used to validate AI/ML medical devices.

This device is an orthopedic implant, and its clearance is based on substantial equivalence to predicate devices through mechanical testing, material characterization, and indications for use, not through a clinical performance study involving AI/ML algorithms.

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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 Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Precision Spine Reform® POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Reform® POCT System is a posterior spinal fixation system intended for fusion of the Occipital, Cervical, and Thoracic regions of the spine (Occiput-T3). The system consists of a variety of rods, occipital plates, occipital screws, polyaxial screws, cross-connectors, lateral offset, domino connectors, and hooks to achieve an implant construct that closely matches patient anatomy. The Reform POCT System implants are fabricated from titanium, titanium alloy, or cobalt chromium alloys as described by standards such as ASTM F136, ASTM F1537, or ISO 5832-3. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instruments necessary for inserting and securing the implants. The components are supplied clean and "NON-STERILE". All implants are single use only and should not be reused under any circumstances.

Based on the provided K172495 document for the Precision Spine Reform® POCT System, here's a description of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) summary for a spinal fixation system, which is a medical implant. The "acceptance criteria" and "study" described in this document refer to mechanical and material performance testing for substantial equivalence against predicate devices, not a clinical study involving human patients or an AI algorithm’s performance. Therefore, many of the typical questions for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies) are not applicable to this type of device submission and thus cannot be answered from the provided text.

Acceptance Criteria and Device Performance for Precision Spine Reform® POCT System (K172495)

The acceptance criteria for the Reform® POCT System are not explicitly listed with numerical targets in the document. Instead, the study's goal was to demonstrate substantial equivalence to legally marketed predicate devices based on technological characteristics and mechanical performance. The implicit acceptance criterion is that the device's mechanical performance is "substantially equivalent" to the specified predicate devices.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

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

• Sample Size: The document does not specify the exact number of devices or constructs tested for dynamic axial compression and dynamic torsion. It only states that "The Reform® POCT System has been tested in the following test modes." For mechanical testing, this typically involves a sufficient number of samples to generate statistically meaningful data for comparison.
• Data Provenance: The testing was "non-clinical testing" and was conducted to support the 510(k) submission. The document does not provide details on the location of the testing facility (e.g., country of origin), nor does it describe data as retrospective or prospective (as this terminology applies to clinical studies, not mechanical bench testing).

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic tool. Ground truth in this context is established by standardized mechanical testing protocols (e.g., ASTM F2706) and the physical properties and performance of the device itself compared to predicate devices, not by expert interpretation of images or data.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is mechanical bench testing, there is no "adjudication method" in the sense of multiple human experts reviewing results. The results are quantitative measurements obtained through standardized test methods.

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

• No. This type of study is relevant to diagnostic devices and AI algorithms where human readers interpret medical images or data. It is not applicable to a spinal implant system like the Reform® POCT System, which is evaluated based on its mechanical and material properties.

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

• No. This is not an AI algorithm. Its performance is tested as a standalone mechanical device.

7. The Type of Ground Truth Used:

• The ground truth for this device's performance is established through standardized mechanical engineering tests (e.g., ASTM F2706 for dynamic axial compression and dynamic torsion) performed on the device components and constructs. The performance is then compared to the known performance of predicate devices or to established industry standards to demonstrate "substantial equivalence."

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that uses a "training set."

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

• Not Applicable. There is no training set for this type of device.

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