(179 days)
When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Integrity Spine Core System is a cervical interbody fusion system comprised of lordotic cages in two footprints with varying heights designed to accommodate patient anatomy and may be implanted as a single device via an anterior approach.
The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK, Zeniva ZA-500) that conforms to ASTM F2026. The devices are plasma spray coated with titanium that conforms to ASTM F1580. Additionally, the devices contain tantalum markers that conform to ASTM F560 to assist the surgeon with proper placement of the device.
The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel that conforms to ASTM F899.
The provided text describes a 510(k) premarket notification for a medical device called "The Integrity Spine Core System." This submission is for an intervertebral body fusion device and is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices.
The document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of analytical or clinical performance of an AI/ML algorithm. Instead, it describes non-clinical engineering tests conducted to ensure the physical and mechanical properties of the implant device meet established standards.
Therefore, many of the requested items (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device submission as it is not an AI/ML product.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists non-clinical mechanical tests to ensure the device's structural integrity and performance in vitro. It states these tests were "conducted in accordance with" specific ASTM standards, implying that the device successfully met the requirements of these standards. The acceptance criteria are implicitly those defined by the ASTM standards, but specific numerical thresholds and results are not provided in this summary.
| Test Type | Standard / Method | Reported Performance (Qualitative) |
|---|---|---|
| Static and Dynamic Compression | ASTM F2077-11 | Conducted in accordance; implies met standard |
| Static and Dynamic Torsion | ASTM F2077-11 | Conducted in accordance; implies met standard |
| Subsidence | ASTM F2267-04 | Conducted in accordance; implies met standard |
| Expulsion | ASTM Draft Standard F-04.25.02.02 | Conducted in accordance; implies met standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This is not applicable to the non-clinical mechanical testing described. The "test set" here refers to the physical devices subjected to mechanical loads, not a dataset for an AI/ML algorithm. No information on data provenance is provided or expected for this type of testing.
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 is not applicable. The "ground truth" for mechanical testing is defined by the physical properties and performance against established engineering standards (ASTM). No human experts are involved in establishing this "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. No adjudication method is relevant for objective mechanical testing.
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 is not applicable. This is a medical implant, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a medical implant, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical testing is based on objective measurements against the performance criteria specified in the referenced ASTM (American Society for Testing and Materials) standards. These standards define the acceptable mechanical properties and failure modes for intervertebral body fusion devices.
8. The sample size for the training set
This is not applicable. This is a medical implant undergoing mechanical testing, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" or "ground truth" in the context of AI/ML for this 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.