(117 days)
InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The InFill™ intervertebral body fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ intervertebral body fusion device is provided sterile, for single use only.
The provided text describes the InFill™ Intervertebral Body Fusion Device, its intended use, and the regulatory pathway. However, it does not contain information about a study proving the device meets acceptance criteria in the way a diagnostic AI device would.
This document is a 510(k) summary for a medical implant (spinal fusion device), not a diagnostic AI/ML system. The "performance data" section refers to mechanical and material testing to ensure the device's physical integrity and equivalence to predicate devices, not clinical efficacy or diagnostic accuracy.
Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.
Here's an analysis based on the information that is available, and an explanation of why other requested information is absent:
1. A table of acceptance criteria and the reported device performance
For this device type, acceptance criteria are generally related to mechanical and material properties, demonstrating that the device is as safe and effective as previously cleared predicate devices. The document states:
| Acceptance Criteria (Type of Test) | Reported Device Performance (Implied) |
|---|---|
| Static/dynamic compression | Completed successfully, demonstrating substantial equivalence to predicate devices (per ASTM F2077). |
| Static subsidence | Completed successfully, demonstrating substantial equivalence to predicate devices (per ASTM F2267). |
| Expulsion | Completed successfully, demonstrating substantial equivalence to predicate devices. |
| Biocompatibility | (Implied by use of PEEK and tantalum, materials common to predicate devices accepted for implantation – not explicitly detailed in summary but required.) |
Explanation: The document explicitly states that "All necessary performance testing, has been completed for the InFill™ intervertebral body fusion device including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion. to assure substantial equivalence to the predicate devices." The acceptance criteria for these tests would be defined in the standards themselves and by comparison to the predicate devices. The reported performance is that the device met these criteria, thus assuring substantial equivalence. Specific numerical performance values are not typically included in a 510(k) summary for this kind of mechanical device but would be in the full submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a passive implantable medical device, not a diagnostic or AI system that processes data from a "test set" of patient cases, images, or records. The "test set" for this device would refer to the physical units of the device subjected to mechanical testing. The number of physical units tested is not specified in this summary.
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)
Not applicable. Ground truth, in the context of diagnostic performance, is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and comparison to predicate devices, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical trial settings or for establishing ground truth in diagnostic studies.
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. MRMC studies are used to evaluate the diagnostic performance of systems, often AI-powered ones, by comparing human readers' performance with and without assistance. This is a physical implant, not a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical implant; there is no "algorithm" to run in a standalone fashion.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical performance, the "ground truth" is adherence to established ASTM standards (F2077, F2267) and demonstrating equivalence to predicate devices which have been previously cleared based on similar standards. It does not involve expert clinical consensus, pathology, or outcomes data in the sense of a diagnostic device.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary regarding the device and its compliance:
The InFill™ Intervertebral Body Fusion Device is a Class II medical device, which achieved 510(k) clearance by demonstrating "substantial equivalence" to predicate devices (NuVasive CoRoent System, K071795; Globus Medical Patriot Transcontinental LLIF Spacer K093242). This means that its intended use, principle of operation, technological characteristics, and safety/effectiveness profiles were found to be similar enough to already-marketed devices. The "study" mentioned refers to mechanical and material performance testing (static/dynamic compression, static subsidence, expulsion) conducted according to established ASTM standards (F2077, F2267). The device met these engineering performance criteria, allowing it to be deemed substantially equivalent.
§ 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.