(25 days)
Custom Spine Issys Pedicle Screw System is used for the following human spine pathologies:
- Deformity
- Trauma & Tumor
When used as pedicle screw fixation system of the non cervical posterior spine (T1-S1) in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
In addition these systems are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 and 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass
The Custom Spine Issys Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct to provide stabilization and promote spinal fusion. It is used as an as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The system consists of bone screws, a polyaxial screw head, saddle pin, spinal rods, and blocker screws and is designed to facilitate optimal screw and rod placement. Instruments made and is doble grade stainless steel are also provided which provide for the application and removal of the implant.
The provided document describes a 510(k) premarket notification for the Custom Spine Issys Pedicle Screw System, which demonstrates substantial equivalence to predicate devices rather than undergoing a de novo clinical study with specific acceptance criteria as would be typical for novel devices. Therefore, the information provided does not contain the level of detail requested for a comprehensive study.
However, based on the available information, I can extract and infer the closest equivalent details.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are implied by demonstrating that the new device performs as well as or similarly to the predicate devices. The performance data presented is typically bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate devices (Moss-Miami Spinal System, Universal Spinal System, Optima Spinal System) as per ASTM F1717 | Bench testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalency to the Moss Miami Spinal System, Universal Spinal System, and Optima Spinal System. The FDA found the device substantially equivalent. |
| Substantial equivalency in design, materials, construction, and intended use as predicate devices. | The Issys Pedicle Screw is the same in intended use and technological characteristics as the predicate devices, raising no new safety and efficacy concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "bench testing in accordance with ASTM F1717."
- Sample Size: Not explicitly stated. ASTM F1717 specifies various test methods for spinal implant constructs, and the sample size would typically be determined by the specific sub-tests performed. Without the full test report, the exact number of tested constructs is unknown, but standard practice usually involves a minimum of 3-5 samples per test condition for mechanical testing.
- Data Provenance: The testing was conducted by Custom Spine, likely in a laboratory setting, as "bench testing." This is not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the study described is a bench test for mechanical equivalence, not a clinical study involving expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as above. No human adjudication of patient data was required for this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence through bench testing to established predicate devices, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a mechanical pedicle screw system, not an AI/software device.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence was the established performance specifications and characteristics of the predicate devices as defined by the ASTM F1717 standard and by comparing the design, materials, construction, and intended use. The physical and mechanical properties of the Issys Pedicle Screw System were expected to meet or exceed those of the predicate devices.
8. The Sample Size for the Training Set
This section is not applicable. This is a hardware medical device, and there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for this device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.