(28 days)
The uses for the Osteonics® Long Arm Containment Ring, as part of the legally marketed Osteonics® Spinal System, are as follows:
Non-Pedicular Use; fixation of the T4-S2 spine:
- Long and short curve scoliosis
- Vetebral fracture or dislocation
- Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Previously failed fusion
- Spinal tumor
Pedicular Use:
- When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.
The Osteonics® Long Arm Containment Ring is placed over the long arms of the screw to aid the physician in achieving a clean break along the scored sections of the screw arms. Additionally, placement of the Osteonics® Long Arm Containment Ring over the body of the screw protects soft tissues and prevents the arms of the screw from spreading as the screw blocker is tightened. The locking mechanism of the containment ring is identical to that of the Osteonics® Spinal System Low Profile Cap. The containment ring does not replace the Low Profile Cap, rather, it offers surgeons an alternative to the Low Profile Cap, if so desired.
This document is a 510(k) Premarket Notification for the Osteonics® Long Arm Containment Ring, a component of the Osteonics® Spinal System. It aims to demonstrate substantial equivalence to a predicate device. The information provided focuses on the device's design, materials, and intended use, and does not include details of a study that directly proves the device meets specific performance acceptance criteria through quantitative results.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain the acceptance criteria or a study with performance data in the way you've outlined for a medical device's performance evaluation. The review is based on substantial equivalence to a predicate device.
However, I can extract information related to the device description and the basis of its acceptance (substantial equivalence), which partially addresses your request.
Here’s what I can provide based on the document:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state quantitative acceptance criteria or report specific numerical performance data from a study for the Osteonics® Long Arm Containment Ring. The acceptance is based on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics through a new study.
The "performance" described is in terms of the device's functional role and safety profile being consistent with the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in comparison) | Reported Device Performance (as described in the submission) |
|---|---|---|
| Intended Use | Identical to predicate device | Non-Pedicular Use (T4-S2 spine): Long and short curve scoliosis, vertebral fracture or dislocation, spondylolisthesis, degenerative disc disease, previously failed fusion, spinal tumor. |
| Pedicular Use (L5-S1 for severe spondylolisthesis): For patients (a) with severe spondylolisthesis (Grades 3 & 4) at L5-S1; (b) receiving fusions with autogenous bone graft only; (c) with device fixed/attached to lumbar/sacral spine; (d) with device removed after solid fusion mass. Pedicle screws not intended for placement above L3. | ||
| Material | Identical to predicate device | ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI) |
| Design / Functionality | Consistent with predicate device, no new safety/effectiveness questions raised by differences. | Placed over long arms of screw to aid physician in achieving clean break along scored sections. Protects soft tissues and prevents screw arms from spreading during blocker tightening. Locking mechanism identical to predicate. |
| Differences from predicate: Diameter of hole providing access to screw blocker increased; external diameter 1mm larger (15mm vs. 14mm). | ||
| Sterilization & Packaging | Standard methods | Employs standard sterilization and packaging methods. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a test set or associated sample size for evaluating the performance of the Osteonics® Long Arm Containment Ring. The submission relies on a "supporting testing summary" and "pre-clinical data incorporated by reference to a prior submission" for the substantial equivalence claim. There is no mention of a specific new study with a test set conducted for this particular device submission.
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)
This information is not applicable as the document does not describe a performance study with a test set requiring ground truth establishment by experts. The review for this 510(k) is based on comparison to a predicate device and existing pre-clinical data from prior submissions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document does not describe a performance study with a test set that would involve 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 information is not applicable. The device is a surgical implant component, not an imaging or diagnostic device that would typically involve human readers or AI assistance in the way described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a surgical implant component, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable as the document does not describe a performance study for this specific device requiring ground truth. The acceptance is based on substantial equivalence, which implies the predicate device's established safety and effectiveness.
8. The sample size for the training set
This information is not applicable as the document does not describe a new study involving a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document does not describe a new study involving a training set and ground truth establishment.
In summary, the provided 510(k) Premarket Notification operates on the principle of substantial equivalence to an already legally marketed predicate device (Osteonics® Spinal System Low Profile Cap). This means that the manufacturer is arguing that their new device is similar enough in intended use, materials, and design to the predicate that it raises no new questions of safety or effectiveness, and therefore does not require new, extensive clinical performance studies as would be the case for a novel device. The "acceptance criteria" are effectively the demonstration of these similarities and the lack of new risks.
§ 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.