(53 days)
The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.
The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC cages are made of PEEK (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum markers conforming ASTM F560 to visualize the position of the implant in the disc space. The SteriSpine™LC cages are available in several sizes to adapt to anatomical variations. The SteriSpine™LC range of products is supplied sterile with a sterile single-use set of surgical instruments.
The provided text is a 510(k) summary for the STERISPINE™ LC CAGE device. It largely focuses on demonstrating substantial equivalence to predicate devices, particularly concerning changes to surgical instruments and packaging, rather than presenting a performance study for the device itself or an AI component.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in this document. The device in question is an intervertebral body fusion device, not an AI/ML powered device. The document describes non-clinical tests conducted to support substantial equivalence for modifications to the device's instruments and packaging, not a study to prove meeting acceptance criteria for a device's performance in a clinical setting.
Below is an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for the STERISPINE™ LC CAGE device in the context of clinical performance. | Non-clinical testing results demonstrate that the performance of the subject device system is substantially equivalent to the cited predicates. Specifically, testing conducted for modifications (new or modified raw materials for instruments, packaging, and sterilization revalidation) confirmed compliance with relevant ISO standards. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not available for the type of testing described (non-clinical tests for substantial equivalence of device modifications, not a clinical performance study with a test set of data). The testing was for biocompatibility, packaging validation, and sterilization revalidation of materials and processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not available. The document refers to non-clinical tests (biocompatibility, packaging, sterilization) and not a study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable and not available. The testing described does not involve an adjudication method for a test set.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for an intervertebral body fusion device and did not involve an AI component or analysis of human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This submission is for an intervertebral body fusion device and did not involve an algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The non-clinical tests (biocompatibility, packaging, sterilization) did not utilize ground truth in the context of clinical expert consensus, pathology, or outcomes data. Ground truth, in this context, would be compliance with the specified ISO standards for the respective tests.
8. The Sample Size for the Training Set
This information is not applicable and not available. The document describes non-clinical tests for device modifications, not an AI/ML model for which a training set would be used.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not available. As there is no AI/ML model or training set, the concept of establishing ground truth for a training set does not apply.
§ 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.