(72 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 STERISPINET™ PS a supplemental fixation system cleared, by the FDA for use in the lumbar spine
SteriSpine™LC range of products consists of lumbar Interbody fusion devices available in sizes to adapt to anatomical variations. SteriSpine™LC is dedicated to transforaminal approach and is manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of tantalum conforming to ASTM F560-08 are used to visualize the position of the implant in the disc space. STERISPINE LC Lumbar Interbody Devices are supplied sterile with a single-use set of surgical instruments.
Here's an analysis of the provided text regarding the STERISPINE LC device's acceptance criteria and study information:
Key Takeaway: The STERISPINE LC device's acceptance criteria and studies are focused on demonstrating mechanical equivalence to predicate devices. There is no clinical data presented in this 510(k) summary, meaning no studies assessing AI performance, human reader improvement, or standalone algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Shearing (ASTM F2077-03) | "Results demonstrate comparable mechanical properties to the predicate device." |
| Compression (ASTM F2077-03) | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Torsion (ASTM F2077-03) | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Subsidence (ASTM F2267-04) | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Expulsion Testing | "Results demonstrate comparable mechanical properties to the predicate device." | |
| Instrumentation Evaluation | Cadaver Testing | "Cadaver testing performed to validate the instrumentation have been presented." (No specific quantitative results provided for acceptance criteria). |
Note: The acceptance criteria are implicitly met by achieving "comparable mechanical properties to the predicate device." The submission does not specify numerical thresholds for these properties but rather relies on a comparative assessment.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The provided document details mechanical and cadaveric testing, not clinical studies or AI model evaluations with a "test set" of patient data.
- Data Provenance: Not applicable. The studies are non-clinical mechanical tests and cadaveric studies, not involving patient data from specific countries or types of studies (retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus. For cadaver testing, the "ground truth" would be the successful validation of instrument function, likely assessed by surgeons or relevant technical personnel, but no specific number or qualifications are mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for clinical or diagnostic studies involving human interpretation or consensus, which are not described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study Done? No. The submission explicitly states: "No clinical data has been presented." Therefore, no MRMC study assessing human reader improvement with or without AI assistance was performed or presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study Done? No. This device is an intervertebral body fusion device (an implantable medical device), not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- For Mechanical Testing: The ground truth is based on established engineering standards (ASTM F2077-03, ASTM F2267-04) and the mechanical properties of the legally marketed predicate devices (Lumbar I/F cage manufactured by Depuy Acromed and Zavation IBF System manufactured by Zavation LLC).
- For Cadaver Testing: The ground truth is the successful validation of the instrumentation's function in a simulated surgical environment (cadavers).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI algorithm, so there is no training set mentioned or relevant in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set 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.