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The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

Invictus SI.CORE Screws are intended for sacroiliac joint fusion for the following conditions:

· Sacroliac joint dysfunction that is a direct result of sacrolliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Invictus CORE and Invictus SI.CORE Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine. Invictus SI.CORE bone screws are intended to provide sacroiliac joint fusion in sacral alar iliac (SAI) trajectories. Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be with Invictus Bone Cement, a self-hardening and ready to use used polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty.

The Invictus Patient Specific Rods are used to connect pedicle screws, hooks, and connectors across different levels of vertebral bodies to create a rigid construct. They are intended to be used with standard Invictus instrumentation. The Invictus Patient Specific Rods are available in 05.5 mm and 6.0 mm diameters and will be provided in lengths between 20 - 600 mm. Equivalent to cleared Invictus rod materials, the rods are made from five different materials: Commercially Pure Titanium (CP Ti Grade 4), Titanium Alloy (Ti-6Al-4V ELI), and three different formulations of Cobalt Chromium (Co-28Cr-6Mo). All Invictus Patient Specific Rods are provided pre-contoured to the surgeon's plan based on the patient's anatomy by means of an industrial bending process prior to distribution for surgery. There is no need for additional bending during surgery.

The purpose of this submission is to expand indications for use of Invictus SI.CORE screws as sacroiliac joint fusion devices, and to add a range of Invictus Patient-Specific Rods to the Invictus Spinal Fixation System.

The provided text is a 510(k) premarket notification letter and summary for the Invictus® Spinal Fixation System. It focuses on establishing substantial equivalence to previously cleared predicate devices through engineering analysis and rationale, primarily for the expansion of indications for use for Invictus SI.CORE screws and the addition of Invictus Patient-Specific Rods.

This document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies cannot be found within this document. This 510(k) submission relied on non-clinical data (engineering analysis and rationale) to demonstrate substantial equivalence.

To answer your prompt, I would need a different type of document, such as a clinical study report or a different section of a regulatory submission that details performance testing against specific acceptance criteria.

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The KHEIRON System, including patient specific K-ROD, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progresive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

The system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

K-RODs are titanium alloys bent rods, available in diameters 5.5mm and 6mm, which shape is a 3D spline designed to meet the need of specific correction of a patient.

K-RODs are to be used as a part of the KHEIRON® Spinal Fixation System (K201659) to reach intended use. KHEIRON® Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the spinal fixation system offers an excellent mean of stabilizing of a specific spinal segment. KHEIRON® Spinal Fixation System includes screws, rods and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailormade. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The K-ROD patient specific devices are available in Ø5.5 and Ø6mm.

This document is a 510(k) Premarket Notification for a medical device called the KHEIRON® Spinal Fixation System, specifically an extension for patient-specific bent rods called K-RODs.

Based on the provided text, the device in question is a spinal fixation system component (K-ROD), not an AI/software medical device. As such, the typical acceptance criteria and study designs applicable to AI/software performance evaluations (which involve metrics like sensitivity, specificity, AUC, MRMC studies, and ground truth establishment from expert reads or pathology) are not relevant to this submission.

This 510(k) submission focuses on demonstrating substantial equivalence of the new K-ROD (a physical implant) to existing predicate devices. The "acceptance criteria" here refer to mechanical and material performance standards for orthopedic implants, not diagnostic accuracy or clinical effectiveness in the way an AI algorithm would be evaluated.

Therefore, I cannot extract the information required in your request about AI/software performance studies, ground truth, expert consensus, MRMC studies, or training/test set sample sizes, because this type of study was not performed or described in this document.

Here's what can be extracted, based on the document's content, explaining why the requested information regarding AI/software performance is not applicable:

Non-Applicability of AI/Software Performance Criteria:

The KHEIRON® Spinal Fixation System and its K-ROD component are physical medical devices (implants), not software or AI-based diagnostic/assistive tools. The FDA 510(k) process for such devices primarily evaluates mechanical safety, material compatibility, and substantial equivalence to legally marketed predicate devices, rather than diagnostic accuracy or AI algorithm performance.

Therefore, the following points from your request are not applicable and are not addressed in this 510(k) submission:

• Table of acceptance criteria and reported device performance for AI-specific metrics: Not relevant, as this is a physical implant.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not relevant for physical implant mechanical testing in the context of AI.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for physical implant mechanical testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not relevant for physical implant mechanical testing.
• 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 relevant, as this is not an AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for physical implant mechanical testing.
• The sample size for the training set: Not relevant, as this is not an AI system that requires a training set.
• How the ground truth for the training set was established: Not relevant, as this is not an AI system.

Information Related to the Actual Device Performance (Mechanical Testing):

While the document doesn't provide the detailed acceptance criteria and results in a table format, it states:

• Acceptance Criteria & Reported Performance (General Statement): "The testing showed that the K-ROD met or exceeded acceptance criteria." (Section 12)
• Sample Size: Not specified for the mechanical tests, but a specific number of samples would have been tested per standard.
• Data Provenance: The tests were non-clinical, likely performed in a lab setting by the manufacturer (S.M.A.I.O.). No country of origin for "data" in the sense of patient data.
• Ground Truth: For a physical device, ground truth relates to meeting established engineering and material standards.
• Training Set/Ground Truth for Training: Not applicable.

Studies Performed (Non-Clinical):

The document lists the following non-clinical tests performed (Section 12):

• "3-point flexion comparison between 90° rods bent with different rod bending processes (KHEIRON curved rod versus K-ROD)"
• "Dynamic axial compression bending and static torsion per ASTM F1717 (K-ROD versus PASS LP patient specific rod comparison)"
• "Literature review to support the addition of the patient-specific K-ROD."

Clinical Studies:

• "No clinical studies were performed." (Section 13) This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicate devices.

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The PASS OCT spinal system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical 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 PASS OCT spinal 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.

In order to achieve additional levels of fixation, the PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.

The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.

The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.

The purpose of this submission is to add Patient Specific, UNiD OCT rods. The Patient Specific Rod is a rod bent before surgery by MEDICREA, following the design defined by the surgeon only specific to a unique patient.

The provided document is a 510(k) summary for a medical device called "PASS OCT Patient Specific Rods." This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing studies to meet specific acceptance criteria in the manner one might find for a novel AI/software product. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, expert qualifications, and specific study designs (like MRMC or standalone performance) is not applicable or not present in this type of submission.

However, I can extract the information that is present and indicate where the requested details are not provided.

Here's a breakdown based on the provided text:

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

• Static Compression
• Dynamic Compression
• Static Torsion
• Dynamic Torsion | Met:
• Mechanically evaluated following ASTM F2706-08.
• Conducted on a justified worst case.
• IMPLICITLY met, as the submission concludes substantial equivalence based on these tests. The document does not provide specific numerical outcomes (e.g., maximum load, cycles to failure) or pass/fail thresholds, but states these tests were performed and support the equivalence claim. |

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 for test set: The document states that "the mechanical test was conducted on a justified worst case." This implies that a limited number of samples (perhaps one or a few representing the worst case) were tested to demonstrate mechanical properties. It does not specify the exact number of samples.
• Data provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. This submission is for a physical medical device (spinal rods) and relies on mechanical testing standards, not clinical assessments by experts for "ground truth" in the context of image analysis or diagnostic algorithms.

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

• Not applicable/Not provided. This is not relevant for mechanical testing of spinal rods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a submission for a physical medical implant (spinal rods), not an AI or imaging diagnostic device.

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

• Not applicable/Not provided. This is not relevant for a physical medical implant.

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

• For the non-clinical (mechanical) tests, the "ground truth" is adherence to ASTM F2706-08 standards for static and dynamic compression and torsion. The device's performance is compared against the expected behavior as defined by these engineering standards.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/software product that requires a training set.

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

• Not applicable/Not provided. This is not an AI/software product that requires a training set or ground truth in that context. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and predicate device designs.

Summary of Study (Non-Clinical Test Summary):

• Study Type: Non-clinical mechanical evaluation.
• Purpose: To demonstrate that the PASS OCT Patient Specific Rods are technologically similar and perform comparably to predicate devices in terms of mechanical safety.
• Methods: Static and dynamic compression tests and static and dynamic torsion tests were performed. These tests followed the ASTM F2706-08 standard.
• Test Cases: The tests were conducted on a "justified worst case" configuration of the device.
• Conclusion: Based on these mechanical tests, the components were concluded to be substantially equivalent to legally marketed predicate devices, implying they met the performance expectations outlined in the standard for safety and effectiveness.
• Clinical Data: The document explicitly states that "Published literature was used to demonstrate substantial equivalence," meaning no new clinical studies were conducted for this 510(k) submission.

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The PASS LP Spinal Systems include a pedicle system intended to provide immobilization 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:

• · Fractures
• · Dislocation
• · Failed previous fusion (Pseudarthrosis)
• · Spinal Stenosis
• · Degenerative spondylolisthesis with objective evidence of neurological impairment
• · Spinal deformations such as scoliosis or kyphosis.
• · Loss of stability due to tumors.

The PASS LP Spinal Systems are 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 PASS LP also include hooks and sacral/iliac screws indicated for 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), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyhosis, and/or lordosis), tumor. Pseudarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The UNiD Rods have to be used with the PASS LP Spinal System designed to contribute to correction and surqical stabilization of the thoracic, lumbar and sacral spine. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the profile defined by the surgeon only, specific to a unique patient.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136 and ISO 5832-3 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to offer the existing cleared reference in sterile version.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

This Special 510(k) premarket notification is submitted for the additional offering of gamma sterilzed UNiD Rods.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification response from the FDA regarding the "PASS LP Spinal System." It details the device's classification, predicate devices, description, and indications for use. It does not include any performance data, clinical study results, or acceptance criteria.

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