(163 days)
NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.
The indication for use is Degenerative Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis 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 six months of non-operative treatment.
The NEO Cage System™ is an intervertebral fusion device with bone graft intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The cages are intended to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage implants may be implanted via an open posterior approach.
The Neo Cage System™ consists of cages of different lengths, sizes and lordotic angles to adapt to a variety of patient anatomies. The size and form of the devices is adjusted to the morphology of the body and the surgical technique. The cages of the Neo Cage system are made of titanium alloy (Ti6Al4V) according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are either single use only and delivered sterile or reusable. The Instruments are to be used for the implantation of the above mentioned medical devices.
This document is a 510(k) Premarket Notification from Neo Medical S.A. to the FDA for their NEO Cage System™. It outlines the device's indications for use, description, and a summary of the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices.
Let's break down the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the typical sense of a clinical study for a new AI/software medical device where performance metrics (e.g., sensitivity, specificity) are directly tied to specific thresholds.
Instead, this 510(k) submission focuses on non-clinical testing to demonstrate substantial equivalence for a physical medical device (an intervertebral body fusion device). The "acceptance criteria" are implied by the standards and successful completion of the tests, and the "reported device performance" is that the device met these standards.
Here's an interpretation based on the provided "Summary of testing":
| Test Category | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$ (as per ISO 11137-2, VDmax25 method) | "The minimal dose of 25kGy is validated... and confirmed a Sterility Assurance Level SAL of $10^{-6}$." |
| Pyrogenicity | Absence of pyrogens (as determined by LAL-Test) | "The pyrogenicity is tested with the LAL-Test (Limulustest)." (Implies successful completion as no failure is reported, and the conclusion states it meets requirements.) |
| Packaging | Compliance with ISO 11607-1, demonstration of 5-year shelf life and packaging integrity through real-time, accelerated aging, and transport studies. | "The sterile barrier system complies with ISO 11607-1. Real time and accelerated ageing studies as well as transport studies were performed to demonstrate 5-year shelf life and packaging integrity." |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-18 (Chemical Analysis), and ISO 10993-5 (Cytotoxicity); no adverse biological reactions. | "Biological evaluation has been performed in accordance with ISO 10993-1. Chemical Analysis according to ISO 10993-18 and Cytotoxicity testing according to ISO 10993-5 were performed... Cytotoxicity testing and testing of inorganic and organic residues was repeated to confirm biocompatibility of the line extension." (Implies successful as it's concluded it meets requirements). |
| Mechanical Testing | Compliance with ASTM F2077 for static (compression, shear, torsion) and dynamic (compression, shear, torsion) tests; compliance with ASTM F2267 (Subsidence); compliance with ISO 17853 (Wear); successful Expulsion test. Device must withstand forces comparable to its intended use. | "Mechanical testing has therefore been repeated and completed successfully. The following tests were performed in accordance with ASTM F2077... Additional testing included... Subsidence test according to ASTM F2267, Wear testing (debris) according to ISO 17853, Expulsion test." |
| MRI Compatibility | Compliance with ASTM F2052-15 (Magnetic field interactions), ASTM F2182-11a (MRI-related heating), and ASTM F2119-07 (R2013) (Artifacts). Device must be safe for MRI environment and labeled as "MRI conditional." | "The following tests were performed with the new worst-case regarding MRI related issues... Magnetic field interactions ASTM F2052-15, MRI-related heating ASTM F2182-11a and Artifacts ASTM F2119-07 (R2013). The NEO Cage System™ is MRI conditional and information is provided in the labeling." |
| Usability | Demonstration of suitability of instruments and use of the system, including labeling. | "Suitability of the instruments and use of the NEO Cage System™ including its labeling was confirmed in a WetLab study with orthopedic surgeons." |
Regarding the study that proves the device meets acceptance criteria:
The "study" in this context is the comprehensive set of non-clinical performance testing summarized, not a traditional clinical trial or AI model validation study. The document explicitly states: "Clinical Evaluation: Clinical studies were not required, based upon review an evaluation of scientific literature, comparison with similar devices and non-clinical performance data."
Therefore, many of the specific questions about an AI/software device's validation are not applicable here.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the sense of patient data for an AI/software test set. The "samples" would be the physical devices or materials used for the various non-clinical tests (e.g., a certain number of cages for mechanical testing, sterile samples for SAL validation, material extracts for biocompatibility). The document doesn't specify these quantities but successful completion implies sufficient sampling per the referenced standards.
- Data Provenance: Not applicable for patient data. The testing was conducted by Neo Medical S.A. (Switzerland) and its affiliated labs (likely contract labs based on the testing types). The tests followed international standards (ISO, ASTM).
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)
- Experts: Not applicable in the context of establishing ground truth for medical image interpretation or similar.
- The "Usability" study involved "orthopedic surgeons," who are experts in their field, to confirm the suitability of the instruments and system. This is an expert-based review of the physical device and its surgical use, not ground truth for a diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" in the context of human interpretation that would require adjudication. The non-clinical tests are objective measurements against defined standards.
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
Not applicable. This is for a physical intervertebral fusion device, not an AI or imaging diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is the adherence to internationally recognized standards (ISO, ASTM) and successful performance in rigorous non-clinical laboratory tests (e.g., materials characterization, mechanical strength, sterility, biocompatibility).
- For the "Usability" study, the "ground truth" was the expert opinion/confirmation of orthopedic surgeons regarding the suitability of the system.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.