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510(k) Data Aggregation
(201 days)
ACURA Stabilization System is intended to help provide immobilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Degenerative spondylolisthesis
- Trauma (fracture or dislocation)
- Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
- Spinal tumours
- Spinal Stenosis
- Pseudarthrosis
- Previous Failed Fusions
When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pediation in pediatic patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idionathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
The ACURA Stabilization System is a single use implantable system consisting of connecting members (rods) and fixation members (screws, hooks). The hooks are available in different types based on the attachment points on the vertebra such as the Lamina and Transverse Process. The screws are available in multiple diameters and lengths based on variations in the spinal anatomy. Variants in screws are also available based on the surgical procedure requirement such as polyaxial screws, monoaxial screws, uniplanar screws, cannulated screws, fenestrated screws, long tab screws, dual outer diameter screws. Locking caps are available which lock the screw head onto the rods. These devices can be rigidly locked into a variety of configurations as per surgical conditions and are available in a variety of sizes to accommodate individual patient anatomy.
Screws mate with 5.5mm diameter rods. Screws, hooks and cross connectors are intended for posterior use only. Hooks are intended for posterior use only. Similarly, Screws, Rods and Cross-Connectors are intended for both posterior and lateral use.
The devices are made Medical Grade Titanium (Ti6Al4V per ASTM F136), with some rods and polyaxial screw heads also offered as cobalt chromium alloy (Co28Cr6Mo per ASTM F1537).
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
The provided text is a 510(k) summary for the ACURA Stabilization System, a medical device used for spinal stabilization. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the mechanical tests. Instead, it states that "The results of this non-clinical testing show that the strength of the ACURA Stabilization System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the performance of the ACURA Stabilization System met or exceeded the performance of the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength sufficient for intended use and substantially equivalent to legally marketed predicate devices. | The ACURA Stabilization System's static compression bending, static torsion, dynamic compression bending, axial grip, and torsional grip testing results demonstrate its strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
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 specify the sample size used for the mechanical testing (e.g., number of constructs tested). It also does not mention the country of origin of the data or whether the study was retrospective or prospective.
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 question is not applicable to this type of device. The ACURA Stabilization System is a mechanical implant, and its performance is evaluated through engineering mechanical tests, not through expert-reviewed clinical data or ground truth labeling in the context of diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device relies on mechanical testing, not human-reviewed data with 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
Not applicable. The ACURA Stabilization System is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through standardized material and mechanical testing specifications (e.g., ASTM F136, ASTM F1537, ASTM F1717-18, ASTM F1798). The performance is compared against the known performance of legally marketed predicate devices in these tests.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or a training set.
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(55 days)
The SEA-LINK Anterior Cervical Plate System is intended for temporary stabilization of the anterior cervical spine (C2-C7) during the development of cervical spinal fusion achieved through ACDF (Anterior Cervical Discectomy & Fusion) or corpectomy in patients with: • Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- ·Trauma (including fractures)
- •Tumors
- ·Deformity defined as kyphosis, lordosis or scoliosis
•Pseudarthrosis - •Failed Previous Fusions
- •Spondylolisthesis
- •Spinal Stenosis
The SEA-LINK Anterior Cervical Plate System is a single use implantable device to assist in the stabilization of the cervical spine during cervical spinal fusion. The device consists of plates and bone screws and is designed to prevent the bone screws from backing out after implantation.
The SEA-LINK Anterior Cervical Plate is designed to fit the lordosis of the cervical spine and to fit the curved medio - lateral anatomy of the spine. The SEA-LINK Anterior Cervical Plate System accommodates from single Level up to five-Level. The plate lengths range from 19mm to 114mm (end to end length) with a width and thickness of 17mm and 2.1mm respectively.
The screws offered are of self-drilling and self-tapping variations. The screws offered are variable angle and fixed angle thus providing four (4) types of screws. The screw diameters are 4mm and 4.5mm. The screw lengths range from 10mm to 20mm. A locking mechanism consisting of a cam fixed atop the plate is used to prevent screw back out.
The device is made from Medical Grade Titanium Alloy (Ti6A14V, ASTM F136).
This document is a 510(k) Premarket Notification from the FDA for the SEA-LINK Anterior Cervical Plate System. It describes a medical device, its intended use, and its equivalence to legally marketed predicate devices, primarily through mechanical testing. It does not contain information about a study involving AI or human reader performance for an imaging-based medical device.
Therefore, I cannot extract the information required to answer your questionnaire about such a study. The provided text discusses:
- Device Type: An implantable medical device for spine stabilization (anterior cervical plate system).
- Assessment Method: Primarily mechanical/performance testing (static compression bending, static torsion, dynamic compression bending) per ASTM standards to demonstrate substantial equivalence to predicate devices.
- No mention of:
- Image analysis or AI.
- Human readers or their performance with or without AI assistance.
- Ground truth establishment based on expert consensus, pathology, or outcomes data in the context of an imaging study.
- Training or test sets for an AI model.
The prompt specifically asks for details related to acceptance criteria and a study proving a device meets these criteria, with explicit mention of AI, human readers, and ground truth for a test set. This document does not provide any of that information.
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