(120 days)
The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft. for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.5mm to 6.5mm, including the PROTEX® or REVERE® or BEACON™ System, using corresponding parallel connectors.
The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System consists of 3.5mm rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, occipital plates, and tapered rods. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138). Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be connected to stainless steel implants.
The provided document describes a 510(k) premarket notification for the ELLIPSE™ Occipito-Cervico-Thoracic Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a clinical trial with acceptance criteria for device performance as would be seen in a PMA.
Therefore, much of the requested information (acceptance criteria, details of a specific study proving it, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not typically present in a 510(k) submission for a spinal implant system. These submissions primarily rely on mechanical testing and comparison to predicate devices, not clinical studies in the way an AI/software device would.
Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing.
Acceptance Criteria and Device Performance Study for ELLIPSE™ Occipito-Cervico-Thoracic Spinal System (K090565)
The provided document describes a 510(k) premarket notification dossier for a medical device rather than a clinical study report with performance metrics. As such, the concept of "acceptance criteria" and "device performance" in the context of a new drug or advanced AI diagnostic device does not directly apply here. Instead, the "acceptance criteria" are the regulatory requirements for demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and comparison of technical characteristics and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (implied by 510(k) review) | Reported Device Performance / Method of Proof |
|---|---|
| Mechanical Performance | "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." |
| (Specific results are not provided in this summary, but the claim is that such testing was performed and met the guidance requirements.) | |
| Material Composition | Implants composed of titanium alloy (per ASTM F136, F1472, or F1295), or stainless steel (per ASTM F138). |
| (Conformity to these standards is an implicit acceptance criterion.) | |
| Technical Characteristics | "The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System implants are similar to the predicate devices with respect to technical characteristics..." |
| Intended Use | "The ELLIPSE™ Occipito-Cervico-Thoracic Spinal System implants are similar to the predicate devices with respect to... intended use." |
| (The provided "Indications for Use Statement" details the intended use, and substantial equivalence implies this closely matches the predicate.) | |
| Safety and Effectiveness (by equivalence) | Device is "substantially equivalent" to legally marketed predicate devices, implying comparable safety and effectiveness. |
| Biocompatibility | (Not explicitly mentioned in the provided text, but implied by regulatory requirements for implantable devices and compliance with material standards.) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "test set" in the context of patient data or clinical samples. The "test" described is mechanical testing. The sample size for mechanical testing (i.e., number of devices or components tested) is not provided in this summary.
- Data Provenance: Not applicable in the context of a clinical test set. The mechanical testing would have been conducted in a laboratory setting, likely in the US, given the company's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This information pertains to clinical studies often involving expert review of images or patient data to establish a 'ground truth' for diagnostic performance. A 510(k) for a spinal implant system does not typically involve this type of ground truth establishment. Mechanical testing relies on engineering standards and measurements, not human expert consensus for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See explanation for #3.
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 is a spinal implant system, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a spinal implant system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Standards and Specifications: For mechanical testing, the "ground truth" would be established by validated test methods, material specifications (e.g., ASTM standards), and engineering design criteria that define acceptable loads, fatigue life, and other mechanical properties. There is no biological "ground truth" in the sense of pathology or outcomes data for this specific submission's evidence.
8. The sample size for the training set
- Not Applicable. This device did not involve a "training set" of data for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See explanation for #8.
§ 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.