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The Curiteva Porous PEEK Standalone ALIF devices are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The Curiteva Porous PEEK Standalone ALIF spacer is an interbody fusion device to be used with three titanium alloy screws or anchors. When used with screws, the system is a standalone interbody fusion device. When used with anchors, the system is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

The Curiteva Porous PEEK ALIF devices are intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

The Curiteva Porous PEEK Standalone ALIF System implants are provided sterile or non-sterile, are single-use devices, and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The subject system consists of interbody spacer implants that are generally box-shaped with an open central corridor to permit packing with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system also provides screws and anchors that can be inserted through the anterior portion of the spacers into adjacent vertebral bodies for bony fixation.

The Curiteva Porous PEEK Standalone ALIF System implants are manufactured from implant-grade PEEK (per ASTM F2026), Titanium alloy (per ASTM F136), and Tantalum (per ASTM F560). All Porous PEEK interbody spacers are additionally surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The provided FDA 510(k) Clearance Letter for the Curiteva Porous PEEK Standalone ALIF System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as typically found for devices involving AI/ML and diagnostic performance.

This document describes a traditional medical device (an intervertebral body fusion device) primarily evaluated through non-clinical performance testing (mechanical testing) for substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable to the information provided in this regulatory submission.

Here's an assessment based on the provided text, indicating where information is not present or not applicable:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Curiteva Porous PEEK Standalone ALIF System is an intervertebral body fusion device. Its clearance is based on demonstrating substantial equivalence to legally marketed predicate devices through comparison of design, intended use, material composition, function, range of sizes, and non-clinical performance testing.

The "acceptance criteria" in this context are related to the mechanical performance and safety of the implant, demonstrating that it is as safe and effective as existing cleared devices. The "study" proving this involves a series of in-vitro biomechanical tests.

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document states that the results "demonstrate that the strength and performance... is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical acceptance values or detailed performance data are not provided in this summary, as is typical for 510(k) summary documents which focus on the conclusion of substantial equivalence rather than raw data.

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

• Sample Size for Test Set: This information is not provided in the document. For biomechanical testing, sample sizes are typically specified per test (e.g., n=6, n=10 per group).
• Data Provenance: The testing is described as "non-clinical testing" and performed on the "subject Curiteva Porous PEEK Standalone ALIF System." This indicates in-vitro (benchtop) testing of the device itself, not human or patient data. Therefore, country of origin or retrospective/prospective classification is not applicable.

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

• Not Applicable. This type of device (a physical implant) does not involve AI/ML or diagnostic image interpretation where expert ground truth establishment for a test set would be relevant. The "ground truth" for mechanical testing is established by the specified ASTM standards and the physical properties of the material and design.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no ground truth established by experts, an adjudication method is not relevant.

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

• No. An MRMC study is relevant for diagnostic devices (e.g., AI for image interpretation) to compare human performance with and without AI assistance. This device is an implantable surgical device, so an MRMC study was not performed, nor is it applicable.

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

• Not Applicable. This concept applies to AI/ML algorithms, not to a physical implantable device.

7. The Type of Ground Truth Used

• For the non-clinical performance testing, the "ground truth" is defined by the established engineering and biomechanical principles and standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877). These standards define acceptable methodologies and performance metrics for intervertebral fusion devices.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

• Not Applicable. As there is no training set, there is no ground truth to be established for it.

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The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Porous PEEK Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary.

All system components are manufactured from Titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The Curiteva Porous PEEK Laminoplasty implants are sterile, single-use devices and available in a variety of different sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants have solid and porous PEEK regions.

The Curiteva Porous PEEK Laminoplasty implants are manufactured from implant-grade PEEK (per ASTM F2026). Each porous PEEK implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Curiteva Porous PEEK Laminoplasty System. This document is a clearance letter for a medical device and does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or its performance study.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves an AI/ML device meets those criteria, as the input document is not about such a device. The key information points requested (test set sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance, ground truth establishment, training set details) are specific to the validation of AI/ML models, which is not discussed in this medical device clearance document.

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The Curiteva Thoracolumbar Plate System Two Hole and Four Hole Plates are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach below the bifurcation of the greatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation is achieved.

The Curiteva Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-SI ) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Curiteva Thoracolumbar Plate System is an internal fixation device for spinal surgery that consists of various configurations of spinal plates and bone screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. All system implants are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The provided text is a 510(k) premarket notification for the Curiteva Thoracolumbar Plate System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on technological characteristics and non-clinical performance data.

However, the document does not contain information related to software, artificial intelligence (AI), diagnostic performance metrics, or clinical studies involving human readers or ground truth established by experts/pathology/outcomes data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as this information is not present in the provided text.

The "Performance Data" section (F) explicitly states that "Non-clinical testing performed on the Curiteva Thoracolumbar Plate System supports substantial equivalence to predicate devices." It then lists biomechanical tests (static and dynamic compression bending, static torsion, static and dynamic cantilever bending) according to ASTM standards. These are engineering performance tests for a physical medical device, not diagnostic performance criteria for software or AI.

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The Curiteva Porous PEEK Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment with the device.

The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally rectangle-shaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense outer ring with a porous structure lining the central graft corridor. The lateral sides of the implant may contain additional porous structures to allow for improved vascularization of the graft site to aid in fusion.

The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136). Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The provided document is a 510(k) premarket notification for a medical device called the "Curiteva Porous PEEK Lumbar Interbody Fusion System." This document does not pertain to an AI/ML powered device, and therefore, does not contain information about acceptance criteria, study details, or other parameters typically associated with the evaluation of AI/ML devices.

The document discusses the substantial equivalence of the new device to previously cleared predicate devices based on:

• Indications for Use: Treatment of degenerative disc disease (DDD) in the lumbar spine.
• Design Principles: Rectangle-shaped implants with an open central corridor for bone graft, a dense outer ring, and porous structures.
• Material Composition: Implant-grade PEEK with Titanium alloy markers and a hydroxyapatite (HA) coating.
• Performance Testing: Static and dynamic axial compression, static and dynamic compression-sheer, subsidence, expulsion, and particle characterization according to ASTM standards.

The document concludes that the Curiteva Porous PEEK Lumbar Interbody Fusion System is substantially equivalent to the predicate devices and is as safe, effective, and performs as well as, or better than, the predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text.

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The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The provided document is a 510(k) summary for a spinal implant device (Curiteva Laminoplasty System), not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device.

Specifically, the document discusses:

• Acceptance Criteria & Performance: The performance data section (page 4, section F) states that "Non-clinical testing performed on the Curiteva Laminoplasty System supports substantial equivalence to predicate devices." The tests performed are:
  • Static four-point bending per ASTM F2193
  • Dynamic four-point bending per ASTM F2193
  • Axial screw pullout per ASTM F543
    It concludes that the strength and performance are sufficient for intended use and substantially equivalent to the primary predicate device (K032534). However, this refers to mechanical testing of a physical implant, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the following information which is relevant to AI/ML device studies:

1. Table of acceptance criteria and reported device performance (for AI/ML): Not applicable.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth establishment for training set: None of this information is present as the document describes a physical medical device, not an AI/ML algorithm.

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The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally boxshaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick. The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).

This document is a 510(k) summary for a medical device called the "Curiteva Porous PEEK Cervical Interbody Fusion System." This type of document is used to demonstrate substantial equivalence to previously cleared devices rather than providing a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates the device's functional and safety equivalence through non-clinical performance data.

Therefore, many of the requested elements pertaining to clinical study design, ground truth, expert adjudication, and AI performance metrics are not applicable to this type of regulatory submission. I will address the relevant sections based on the provided text.

Here's a breakdown of the requested information based on the provided 510(k) Summary:

Acceptance Criteria and Device Performance Study

The "Curiteva Porous PEEK Cervical Interbody Fusion System" is a medical implant, and its regulatory clearance process (510(k)) focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance acceptance criteria related to AI/ML or diagnostic accuracy, which would typically involve clinical studies with human readers and ground truth.

For this device, the "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates when subjected to a battery of non-clinical (mechanical) tests. The "study that proves the device meets the acceptance criteria" refers to these non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of explicit quantitative "acceptance criteria" with a pass/fail threshold, as might be found for a diagnostic AI, is not detailed in this type of 510(k) summary for a spinal implant. Instead, the performance is demonstrated by showing the device withstands stresses comparable to predicate devices and industry standards. The reported device performance is that the device meets or is sufficient for its intended use and is substantially equivalent to the predicate devices. The specific numerical results of these tests are not included in the summary.

• Axial compression strength | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Compression-shear strength | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Torsion strength | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Subsidence resistance | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - Wear debris characteristics | Sufficient for intended use, substantially equivalent to predicate devices. |
  | - (Additional tests like expulsion, impaction) | Sufficient for intended use, substantially equivalent to predicate devices. |
  | Material Compatibility:
• Biocompatibility (implied) | PEEK (ASTM F2026) with Titanium alloy markers (ASTM F136), HA coating. |

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

The "test set" in this context refers to the physical samples of the Curiteva Porous PEEK Cervical Interbody Fusion System that underwent mechanical testing. The specific number of samples tested for each mechanical test is not provided in the summary.

Data Provenance: The data comes from non-clinical (laboratory) testing conducted on the manufactured device models. There is no mention of country of origin of the data or whether it's retrospective/prospective, as these terms are generally applicable to clinical human data.

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

This question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic performance studies. For an intervertebral body fusion device, mechanical properties are evaluated against engineering standards and comparison to predicate devices, not against expert interpretation of patient data.

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

This question is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus "ground truth" among multiple readers. For mechanical testing of an implant, the results are derived from physical measurements and engineering analyses, not from human interpretation 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

This question is not applicable. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images, often with or without AI assistance. This submission pertains to a physical spinal implant.

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

This question is not applicable. This refers to AI algorithm performance. The Curiteva Porous PEEK Cervical Interbody Fusion System is a physical medical implant, not an algorithm.

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

This question is not applicable in the traditional sense of clinical "ground truth." For mechanical tests, the "ground truth" is defined by established engineering principles, ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877), and the performance characteristics of previously cleared predicate devices. The device's performance is compared against these engineering benchmarks and predicate device data.

8. The sample size for the training set

This question is not applicable. A "training set" refers to data used to train an AI/ML algorithm. This device is a physical implant and does not involve AI/ML.

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

This question is not applicable. As there is no AI/ML training set, there is no ground truth established for it.

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The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Curiteva Navigation System instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Curiteva screws.

The Curiteva Navigation System includes awls, probes, taps, drills, and drivers. The Curiteva Navigation System instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System, as specified.

All instruments are made of stainless steel per ASTM F899. The Curiteva Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

This FDA 510(k) summary (K223200) describes a device that is an accessory to a navigation system, not a standalone AI/software device. Therefore, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (like MRMC studies, training set details, or ground truth establishment by experts for algorithmic performance) are not applicable to this submission.

The Curiteva Navigation System consists of physical surgical instruments (awls, probes, taps, drills, and drivers) intended for use with an existing, cleared navigation system (Medtronic StealthStation). The performance evaluation focuses on the physical accuracy and compatibility of these instruments, not on an AI algorithm's diagnostic or predictive capabilities.

Based on the provided document, here's an analysis of the acceptance criteria and performance study:

Understanding the Device and its Evaluation

Device Category: Orthopedic Stereotaxic Instrument (accessory to a Computer Assisted Surgical System).
Purpose: To assist surgeons in precisely locating anatomical structures during spinal surgery when used with a Medtronic StealthStation Navigation System.
Nature of Device: Reusable surgical instruments (physical, non-AI).

Acceptance Criteria and Performance Study Summary

Given the nature of the device as surgical instruments, the "acceptance criteria" here refer to testing that demonstrates the instruments' physical accuracy and suitability for their intended use when integrated with the specified predicate navigation system.

1. Table of Acceptance Criteria and Reported Device Performance

The results of this non-clinical testing show that the performance of the Curiteva Navigation System is sufficient for its intended use. This implies that the positional accuracy, as measured by the standard, met predefined acceptance thresholds (though specific numerical thresholds and results are not provided in this summary). |
| Dimensional Comparison to Predicate Devices | Dimensional comparisons were made between the subject and predicate devices.

While specific results are not detailed, this testing would ensure that the new instruments are dimensionally compatible and comparable to existing cleared instruments used with similar navigation systems, without introducing new safety or performance concerns. The conclusion of substantial equivalence implies these comparisons were favorable. |
| Material Compatibility/Safety | All instruments are made of stainless steel per ASTM F899. This ensures the material meets established standards for medical devices, contributing to patient safety (e.g., biocompatibility, corrosion resistance, durability for sterilization). |
| Compatibility with Medtronic StealthStation | The instruments are designed for use only with Medtronic StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) hardware and software. The testing would validate this compatibility. The summary implicitly concludes successful compatibility as it deems the device suitable for its intended use with this system. |
| Compatibility with Curiteva Implant Systems | The instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System. This implies testing or design validation to ensure proper fit and function with these specific implant systems during surgical procedures. |
| Substantial Equivalence to Predicate Device | Conclusion: "The overall technology characteristics and mechanical performance data lead to the conclusion that the Curiteva Navigation System is substantially equivalent to the predicate device [Medtronic Navigated Instruments (K161210)]." This is the overarching acceptance criterion for 510(k) clearance, relying on all the above performance demonstrations. |

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

• Sample Size: The document does not specify a specific "sample size" in terms of patient data. For the positional accuracy testing (ASTM F2554-18), the sample would be the physical instruments themselves or specific test fixtures designed to simulate use. The standard typically involves repetitive measurements to establish accuracy and precision. No human patient test set is described, as this is laboratory testing of the instruments.
• Data Provenance: The testing is non-clinical (i.e., laboratory-based, bench testing). No patient data (e.g., from specific countries, retrospective/prospective studies) is mentioned, as it is not relevant for this type of device and performance evaluation.

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

• Not Applicable. For this type of mechanical/physical device accessory, "ground truth" is established by a standardized measurement method (e.g., a calibrated measurement system validating positional accuracy against a known reference). Experts (e.g., radiologists) are not involved in establishing this specific type of "ground truth." The ground truth for positional accuracy is derived from metrology principles and measurement standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving interpretation of medical images or patient outcomes, especially with AI algorithms. This device's testing is purely technical/mechanical.

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

• No. An MRMC study is relevant for AI or diagnostic devices where human readers' performance (with or without AI assistance) is being evaluated. This is a set of physical surgical instruments, not an AI algorithm.

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

• No. This device is a set of physical instruments, not a software algorithm, so "standalone" algorithm performance is not applicable. Its performance is always "human-in-the-loop" in the ultimate clinical use (surgeon using the instrument). The ASTM F2554-18 test can be considered a "standalone" test of the physical instruments' accuracy when used with the specified navigation system, but it's measuring physical precision, not an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation of these physical instruments is based on quantifiable, objective measurements derived from engineering and metrology standards. Specifically, for positional accuracy, it's defined by the reference measurements and tolerances within the ASTM F2554-18 standard. It is not based on expert consensus, pathology, or clinical outcomes data in this context.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

• Not Applicable. There is no training set mentioned or implied for this device.

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The Curiteva Sacroiliac Joint Fusion System is intended for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Curiteva Sacroiliac Joint Fusion System consists of screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The screws are designed to be implanted across the sacroiliac joint to stabilize and aid in the fusion of the sacroiliac joint. Optional washers are included to aid in the distribution of load across the bone surface directly apposing the screw head.

The Curiteva Sacroiliac Joint Fusion System implants are manufactured from medical-grade titanium alloy in accordance with ASTM F136. All system implants are intended for single use only and should not be reused under any circumstances.

The provided text describes a 510(k) premarket notification for the Curiteva Sacroiliac Joint Fusion System. This submission focuses on establishing substantial equivalence to previously cleared devices through non-clinical performance data, primarily mechanical testing, rather than clinical studies involving AI or diagnostic performance. Therefore, many of the requested details about acceptance criteria for AI performance, clinical study design, and ground truth establishment are not applicable.

Here's an analysis based on the available information:

Assessment of Acceptance Criteria and Device Performance:

The "acceptance criteria" in this context refer to the mechanical performance standards that the device must meet to demonstrate safety and effectiveness comparable to predicate devices. The study conducted was non-clinical mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The specific numerical values for strength and performance are not provided in the summary, only the conclusion that they were "sufficient" and "substantially equivalent."*

2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated in the provided text for each mechanical test. Mechanical testing typically involves multiple samples to ensure statistical validity, but the exact number isn't quantified here.
* Data Provenance: The data is non-clinical, originating from laboratory mechanical testing. There is no patient data involved, so country of origin or retrospective/prospective status is not applicable in the typical sense.

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

   • Not applicable. This is a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth. The "ground truth" for mechanical testing is established by the test standards (ASTM F2193, ASTM F543) and physical measurements.

4. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical or image interpretation studies to resolve discrepancies among experts. For mechanical testing, adherence to a standard and objective measurements are the primary methods.

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 not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.

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

   • Not applicable. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used:

   • The "ground truth" for this non-clinical study is defined by the objective physical properties and performance characteristics measured against established ASTM standards (ASTM F2193 for bending, ASTM F543 for torsion and pullout). The performance is then compared to predicate devices.

8. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI system that requires a "training set."

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

   • Not applicable, as there is no training set for an AI model.

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The Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.

The Curiteva Pedicle Screw System is a thoracolumbar and/or sacral spine fixation system for spinal surgery that consists of a variety of screws, rods, set screws, crosslink connectors, rod connectors, and hooks. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy.

The Curiteva Pedicle Screw System implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Select rods are also available in medical grade Cobalt Chromium alloy (per ASTM F1537). All implants are intended for single use only and should not be reused under any circumstances.

This document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It primarily details the device's design, materials, indications for use, and mechanical performance testing.

Crucially, this document does not describe the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device. The "Curiteva Pedicle Screw System" is a physical medical implant (a pedicle screw system for spinal fixation), not an AI/ML-powered diagnostic or therapeutic device.

The performance data mentioned ("static and dynamic axial compression bend per ASTM F1717 and static torsion per ASTM F1717") refers to mechanical strength and durability testing of the physical hardware, not the performance of an algorithm.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies, as these concepts are not applicable to the type of device described in this document.

The "acceptance criteria" for this implant would be its ability to withstand certain mechanical forces as defined by ASTM standards and demonstrate equivalence to predicate devices in those tests. The "study" is the mechanical testing itself.

If the request was intended for an AI/ML medical device, the provided document does not contain that information.

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