(168 days)
When used as a cervical intervertebral body fusion device, the Galileo™ Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.
The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy
The provided document is a 510(k) summary for the Bright Spine Galileo™ Spinal Spacer System, which is a cervical intervertebral body fusion device. This type of device is an implantable medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance characteristics commonly found in AI/ML device studies.
Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable to this type of traditional medical device submission.
Here's an adaptation of your request based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Manufactured from equivalent materials to the predicate device. | The Bright Spine Galileo™ Spinal Spacer System is manufactured from titanium alloy, which is described as an equivalent material to the predicate Novel® Spinal Spacer System. |
| Dimensional Similarity: Similar dimensions to the predicate device to achieve the same surgical objectives. | The device is described as having similar dimensions to the predicate device, allowing it to achieve the same surgical objectives. |
| Functionality: Functions in a safe and effective manner when used as designed. | The device was shown to be safe and effective and substantially equivalent to the predicate system. |
| Performance Testing (ASTM F2077-03): Includes static and dynamic compression, compressive shear, torsion, and expulsion. | The device complies with ASTM F2077-03. |
| Performance Testing (ASTM F2267-04): Includes subsidence. | The device complies with ASTM F2267-04. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This device's performance was evaluated through mechanical testing against ASTM standards and comparison to a predicate device, not through a clinical "test set" of patients or data in the way AI/ML algorithms are.
- Data Provenance: Not applicable. The performance data comes from mechanical testing, not retrospective or prospective patient data from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in this context, would be established by the engineering standards themselves (ASTM F2077-03 and ASTM F2267-04) and by the FDA's assessment of substantial equivalence based on the provided technical documentation, not by expert consensus on clinical cases.
4. Adjudication method for the test set
- Not applicable. There was no clinical "test set" requiring adjudication. The assessment was based on comparison to a predicate device and compliance with established engineering standards.
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. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Ground Truth: For performance, the "ground truth" is defined by the acceptance criteria specified in the ASTM F2077-03 and ASTM F2267-04 standards. For the overall approval, the "ground truth" is the demonstration of substantial equivalence to the predicate device (Alphatec Spine, Inc. Novel® Spinal Spacer System K081730). This is based on material, dimensional, and functional similarity, as well as adherence to performance standards.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, and no training set was used.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.