(71 days)
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device 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® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
The InFill® interbody 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® interbody fusion device is provided sterile, for single use only.
The provided document is a 510(k) premarket notification from the FDA for the 'InFill® Interbody Fusion Devices'. It primarily discusses the substantial equivalence of the device to existing predicate devices, focusing on technical characteristics and intended use. The document does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific performance criteria in the way a clinical trial or a detailed performance study for an AI/CADe device would.
Instead, the "Performance Data" section specifically states: "An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions."
This means:
- The study performed was a Finite Element Analysis (FEA), a computational modeling technique, not a human reader study or a standalone algorithm performance study with a test set and ground truth.
- The purpose of the FEA was to compare the newly introduced sizes of the InFill device with the existing product family and predicate devices from a mechanical standpoint.
- The "acceptance criteria" referred to are the unspecified "specified criteria" related to mechanical performance, which the FEA demonstrated the device met. The document does not explicitly list these criteria or their values.
- There's no mention of sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or adjudication methods, as these concepts are not applicable to the type of study (FEA) described.
- No MRMC or standalone performance study in the context of an AI/CADe device was conducted or reported.
Therefore, I cannot populate the table or answer most of your specific questions because the provided document does not contain the type of AI/CADe performance study results you are asking for.
However, I can extract the relevant information regarding the "Performance Data" section.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance suitable for interbody fusion devices. | "met all specified criteria" |
| Mechanical performance substantially equivalent to predicate devices. | "demonstrated the substantial equivalence of the new device sizes to the predicate device." |
| Does not raise new safety or performance questions. | "did not raise new safety or performance questions." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study was a Finite Element Analysis (FEA), a computational simulation, not a study utilizing a "test set" of patient data.
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. No ground truth was established by experts for this FEA study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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, an MRMC comparative effectiveness study was not done. The study was a Finite Element Analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The study was a Finite Element Analysis.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The FEA used computational models and simulations, not ground truth derived from clinical data.
8. The sample size for the training set
Not applicable. The study was a Finite Element Analysis.
9. How the ground truth for the training set was established
Not applicable. The study was a Finite Element Analysis.
§ 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.