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510(k) Data Aggregation
(168 days)
IDYS LIF CAGES
The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by FDA for use in the lumbar spine.
The Idys™ LIF Cages consist of PEEK lumbar cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Idys™ LIF Cages also feature markers made of Tantalum according to ASTM F560.
The Idys™ LIF Cages have different anatomic shapes and dimensions based on the surgical approach: PLIF (posterior lumbar interbody fusion); TLIF (transforaminal lumbar interbody fusion); and PTLIF (posterior approach and oblique-TLIF approach).
The Idys™ PLIF Cage is a hollow spacer with openings for autograft on the top, bottom, and sides of the device.
the Idys™ TLIF Cage has a bullet tip to facilitate introduction. The TLIF Cage Holder instrument has a clamp that affixes to the axle to enable rotation of the device during its introduction in situ.
The Idys™ PTLIF Cage is inserted in an oblique position. It can be introduced with a PLIF approach or a TLIF approach to the convenience of the surgeon and with taking into account the profile of the patient.
The Idys™ LIF Cage procedures are performed using a set of surgical instruments common for PLIF and TLIF approaches. Most of the instruments provided are common surgical tools used in these types of interbody fusion procedures. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21 CFR 888.4540.
This document describes the acceptance criteria and the study that proves the device meets those criteria for CLARIANCE's Idys™ LIF Cages.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (as stated in the document) |
|---|---|
| Static axial compression testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Dynamic axial compression testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Static compression shear testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Dynamic compression shear testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Subsidence testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Expulsion testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
| Wear testing | "The results of these studies were determined to be substantially equivalent to legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the performance tests (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion, and wear testing). It only mentions that performance testing was conducted per ASTM F2077 and ASTM F2267.
The data provenance is not specified beyond indicating that the studies were performed by CLARIANCE, a French company. It does not state whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For this type of device (intervertebral body fusion cages), the "ground truth" is typically established through recognized industry standards for mechanical performance rather than expert consensus on medical images or patient outcomes. The document indicates that performance testing was conducted per ASTM F2077 and ASTM F2267. These ASTM standards define the methodologies and acceptance criteria for mechanical testing of spinal intervertebral body fusion devices. Therefore, the "experts" in this context would be those who interpreted and conducted the tests according to these established standards. The document does not specify the number or qualifications of the individuals who performed or interpreted these tests.
4. Adjudication Method for the Test Set
Not applicable for a device performance study based on engineering standards. The performance is objectively measured against the criteria defined by ASTM F2077 and ASTM F2267, rather than requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI, not for mechanical devices like intervertebral body fusion cages.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only without human-in-the-loop performance) study was done. This concept is not applicable to an intervertebral body fusion device, which is a physical implant, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance was the mechanical performance standards specified in ASTM F2077 and ASTM F2267. This includes metrics like static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and wear.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI model that requires a training set. The term "training set" is typically used in the context of machine learning and artificial intelligence.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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