(111 days)
Intervertebral Body Fusion Device: The Innvotec Surgical SEC IBF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC IBF Cage is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the Innvotec Surgical SEC IBF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC IBF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC IBF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC IBF Cage may be used with bone graft.
The SEC IBF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The SEC IBF Cage is manufactured from Ti6Al4V and stainless steel.
The provided text describes the 510(k) summary for the Innvotec Surgical SEC IBF Cage and a letter from the FDA regarding its clearance. It does not present a study with acceptance criteria and reported device performance in the format requested, especially not for an AI/software device.
The document is for a physical medical device (an intervertebral body fusion cage made of Ti6Al4V and stainless steel), not a software or AI-based device. Hence, most of the requested information (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or present in this context.
However, I can extract the relevant information from the provided text regarding the device's performance and its equivalence to established standards, which can be considered its "acceptance criteria" in a regulatory sense for a traditional medical device:
Acceptance Criteria and Device Performance (for SEC IBF Cage - a physical medical device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F2077 performance standards | All applicable requirements were met. |
| Biomechanical integrity of the anterior, middle, and posterior spinal column | Device designed to restore this integrity even in the absence of fusion for a prolonged period. |
| Substantial equivalence to predicate devices | Shown to be substantially equivalent to previously cleared devices. |
| Same indications for use as predicate devices | Has the same indications for use as predicate devices. |
| Same design as predicate devices | Has the same design as predicate devices. |
| Same function as predicate devices | Has the same function as predicate devices. |
| Same materials used as predicate devices | Has the same materials used as predicate devices (Ti6Al4V and stainless steel). |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The testing mentioned refers to performance standards for a physical implant, not a clinical study on human subjects with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" here would relate to whether the device meets engineering specifications and is substantially equivalent to predicates, not clinical diagnostic accuracy.
4. Adjudication method for the test set
This information is not applicable and not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for evaluating human interpretation with and without AI assistance, which is not applicable to a physical spinal implant device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance evaluation of an "algorithm" was not done. This device is a physical implant, not a software algorithm.
7. The type of ground truth used
The "ground truth" for this device's acceptance is based on:
- Compliance with ASTM F2077 performance standards (engineering and material testing).
- Demonstration of substantial equivalence to existing legally marketed predicate devices, implying similar safety and effectiveness based on design, materials, function, and indications for use.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of this physical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" for this physical device.
In summary, the provided document is for a traditional physical medical device (spinal implant) and its 510(k) clearance process, which relies on adherence to performance standards and substantial equivalence to predicates, rather than clinical efficacy studies or AI performance metrics.
§ 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.