(30 days)
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), turnor, 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 svringe and which then can be iniected 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 alloy and delivered sterile. Connectors are made out of titanium allov and delivered sterile. Iliac connectors are being added in this special 510(k).
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 is a 510(k) summary for the BonOs® Inject Bone Cement and NEO Pedicle Screw System™. It outlines the administrative information, device description, indications for use, and a comparison to a predicate device. However, it explicitly states, "No clinical studies were conducted," and the provided "SUMMARY OF PERFORMANCE DATA" primarily focuses on non-clinical, mechanical testing (static and dynamic testing, and axial gripping capacity in accordance with ASTM 1798), usability, biocompatibility, MRI safety, and sterilization validation.
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on clinical outcomes or performance metrics typically seen in AI/ML device studies. It is likely that the "acceptance criteria" here refer to meeting the predicate device's performance through bench testing, rather than performance against a clinical ground truth.
Given this, I cannot fully complete the requested table and answer many of the questions as the information is not present in the provided text. I will indicate where information is missing.
1. A table of acceptance criteria and the reported device performance
Since this is a mechanical device and not an AI/ML diagnostic, the "acceptance criteria" and "reported performance" are typically related to engineering and material standards, not diagnostic metrics like sensitivity or specificity. The document mentions meeting requirements for pedicle screw spinal systems.
| Acceptance Criteria (Implied from text) | Reported Device Performance |
|---|---|
| Requirements for Pedicle Screw Spinal Systems (Spinal System 510(k)s Guidance for Industry and FDA Staff Document, May 3, 2004) | The NEO Pedicle Screw System™ meets these requirements. |
| Static and dynamic testing in accordance with ASTM 1798 | Performed; results demonstrate substantial equivalence to predicate. |
| Axial gripping capacity in accordance with ASTM 1798 | Performed; results demonstrate substantial equivalence to predicate. |
| Usability, Biocompatibility, MRI safety and compatibility, Sterilization process validation (in context of K212489) | Evaluated; results demonstrate substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The performance data described is based on non-clinical (bench) testing, not a clinical test set.
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. No clinical ground truth was established as "No clinical studies were conducted."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication was performed.
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 document does not mention any MRMC study. The device is a physical pedicle screw system and bone cement, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical pedicle screw system and bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established as "No clinical studies were conducted." The closest equivalent to "ground truth" here would be the established engineering standards (ASTM and ISO) and the performance of the predicate device.
8. The sample size for the training set
Not applicable. The device is a physical pedicle screw system and bone cement, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”