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The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (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, curvatures (scolosis, and/or lordosis), tumor, pseudarthrosis, and/ or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intented 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. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is 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 and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

The NEO Pedicle Screw System™ consists of screws, rods and connectors which are available in different sizes. The system includes the relevant instruments which are mainly single use, disposable and delivered sterile, just few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome allov and delivered sterile. Connectors are made out of titanium allov and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The provided text describes a 510(k) premarket notification for the BonOs Inject Bone Cement and NEO Pedicle Screw System. It does not contain information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance testing.

Therefore, I cannot provide the requested information based on the given text. The document refers to:

• Non-clinical performance testing: Static compression bending, dynamic compression bending, static torsion (per ASTM F1717), and axial gripping capacity (per ASTM 1798).
• Biocompatibility testing.
• MRI safety and compatibility evaluation.
• Sterilization cycle validation: In accordance with ISO 11137-2.
• Bacterial endotoxin testing: Per ANSI/AAMI ST72:2011 using the LAL pyrogen testing.
• Usability testing.

However, it explicitly states: "No clinical studies were conducted." This means there is no clinical data from patients or human readers to determine performance metrics against acceptance criteria like sensitivity, specificity, or accuracy in a diagnostic context. This document pertains to a medical device where performance is assessed through mechanical and material properties, not through AI or diagnostic imaging.

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The PERLA® TL posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL posterior osteosynthesis system consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The Perla®TL system is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL posterior osteosynthesis implants are delivered either non sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. The subject product line extension of the PERLA® TL Posterior Osteosynthesis System manufactured by Spineart (K193396) consists of addition of cannulated screws (various models), fenestrated screws (various models), percutaneous rods and associated surgical instruments.

This is a 510(k) premarket notification for a medical device (PERLA® TL posterior osteosynthesis system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and data provenance related to AI/ML performance is not present in the provided document.

The document discusses the substantial equivalence of the PERLA® TL device to legally marketed predicate devices, focusing on:

• Indications for Use: The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions in skeletally mature patients and for adolescent idiopathic scoliosis in pediatric patients.
• Device Description: It consists of screws, rods, set screws, hooks, rod connectors, and cross-connectors made from medical-grade titanium alloy and cobalt chromium. The current submission is a product line extension adding cannulated and fenestrated screws, percutaneous rods, and associated instruments.
• Technological Characteristics: The added components share the same indications for use, function, material composition, design, range of sizes, and mechanical performance as predicate devices.
• Non-clinical Performance Testing: Static compression bending, static torsion, and dynamic compression bending tests were conducted according to ASTM F1717 to demonstrate comparable mechanical properties to predicate devices.

Therefore, the information regarding acceptance criteria, study design, and data specifics that would be relevant for an AI/ML-based device (e.g., sample size, expert consensus, ground truth, effect size) is not applicable to this submission.

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The CarboClear Pedicle Screw System is 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 CarboClear Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.

The CarboClear implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell.

The implants are supplied sterile, and are intended for single use.

I am sorry, but based on the provided document, I cannot extract the specific details about the acceptance criteria, the study that proves the device meets the acceptance criteria, or most of the other requested information (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, training set details).

This document is a 510(k) summary for a medical device (CarboClear® Pedicle Screw System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results in the format you've requested.

Here's what I can tell you from the document:

• Device: CarboClear® Pedicle Screw System
• Purpose: To restore the integrity of the spinal column in patients with advanced-stage tumors involving the thoracic and lumbar spine.
• Performance Data: "Performance characteristics included static and dynamic tests according to ASTM F 1717, and tests according to ASTM F 1798, ASTM F 2193, ASTM F 543; as well as fatigue lateral bending-axial rotation test and rod creep test. The test results are comparable to those of predicate devices, as applicable, demonstrating that the device is safe and effective for its intended use."
• Clinical Data: "Clinical data for the CarboClear System was presented for the target population specified in the indications for use statement, and supports the safety and effectiveness of the device."

However, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm-only) performance (this is a hardware device, not an AI algorithm).
7. The type of ground truth used (beyond general "clinical data").
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This type of information would typically be found in a more detailed clinical study report, which is not part of this 510(k) summary.

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