(448 days)
The NEST-C Interbody System is indicated for use in cervical interbody fusion procedures with autogenous bone graff and/or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or multiple contiguous levels from the C2 to T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have six weeks of non-operative treatment.
The NEST-C Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
The NEST-C Interbody System is intervertebral body fusion device with solid and porous structures that both are simultaneously built using additive manufacturing method, from titanium alloy (Ti6Al4V ELI) powder per ASTM F3001. Offered in a number of footprints heights and lordotic angles to adapt to a variety of patient anatomies. The implant consists of a hollow window for bone graft packing and serrations on the superior/inferior surfaces of the cage for enhanced fixation. The internal porous structure provides additional space for bone graft packing. NEST-C cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
The provided document is a 510(k) summary for a medical device called the NEST-C Interbody System. This type of regulatory submission in the US does not typically include information about clinical studies with human participants comparing the device's performance against detailed acceptance criteria in the way a clinical trial for a drug or an AI diagnostic algorithm would, especially for an intervertebral body fusion device.
Instead, the acceptance criteria for this type of device are primarily based on non-clinical mechanical testing and biocompatibility evaluations to demonstrate substantial equivalence to legally marketed predicate devices. The "device performance" reported is how well the device met these engineering and safety standards.
Here's a breakdown based on the information provided:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NEST-C Interbody System are derived from recognized consensus standards for intervertebral body fusion devices, specifically ASTM F2077-22 (Static and Dynamic Evaluation of Flexible Spinal Intervertebral Body Fusion Devices) and F2267-04 (Mechanical Test for Spinal Artificial Discs). Biocompatibility is evaluated against ISO 10993-1.
While the specific numerical acceptance limits (e.g., minimum load to failure, maximum displacement) are not detailed in this summary, the document states that the device was subjected to these tests and that the "results demonstrate that the devices are substantially equivalent to the identified predicate devices." This implies that the NEST-C Interbody System met or exceeded the performance of the predicate devices in these mechanical and biological tests.
| Acceptance Criteria Category | Specific Test (Standard) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Compression (ASTM F2077-22) | Met requirements; demonstrated substantial equivalence to predicate devices. |
| Static Compression Shear (ASTM F2077-22) | Met requirements; demonstrated substantial equivalence to predicate devices. | |
| Static Torsion (ASTM F2077-22) | Met requirements; demonstrated substantial equivalence to predicate devices. | |
| Dynamic Compression (ASTM F2077-22) | Met requirements; demonstrated substantial equivalence to predicate devices. | |
| Dynamic Torsion (ASTM F2077-22) | Met requirements; demonstrated substantial equivalence to predicate devices. | |
| Subsidence Testing (ASTM F2267-04) (Note: F2267 is for artificial discs, likely applied for subsidence aspects applicable to fusion devices) | Met requirements; demonstrated substantial equivalence to predicate devices. | |
| Biocompatibility | Biological evaluation of medical devices (ISO 10993-1) | Met biocompatibility requirements; safe for clinical use. |
Study Details (Non-Clinical)
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Sample Size Used for the Test Set and Data Provenance:
- Test Set (for mechanical tests): The document refers to "worst case devices" being subjected to mechanical testing. The exact number of samples for each test (e.g., how many devices were tested for static compression, how many for dynamic torsion) is not specified in this summary.
- Data Provenance: The tests are explicitly stated as "mechanical testing" and "biocompatibility evaluation," indicating laboratory-based, non-clinical studies performed by the manufacturer or a contracted lab. The country of origin for this testing is not specified but would likely be Taiwan (where Paonan Biotech Co. is located) or a certified lab it contracted. This is retrospective in the sense that the testing is performed on manufactured devices, not in a live patient setting.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in the context of this 510(k) summary. For mechanical and biocompatibility testing, "ground truth" is established by the accepted scientific and engineering principles codified in the ASTM and ISO standards, and the performance is measured by instrumentation, not human experts. There are no "experts establishing ground truth" in the diagnostic sense for these non-clinical tests.
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Adjudication Method:
- This is not applicable as there is no human interpretation of results requiring adjudication in the context of mechanical or biocompatibility testing. The tests yield objective, quantifiable data measured by laboratory equipment.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation of medical images or data is involved and the AI's impact on reader performance is being assessed. The NEST-C Interbody System is an implantable surgical device, and its safety and effectiveness are primarily demonstrated through non-clinical mechanical testing, biocompatibility, and substantial equivalence to predicate devices.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone performance study was not done. This concept applies to AI algorithms. The NEST-C Interbody System is a physical medical implant.
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Type of Ground Truth Used:
- For mechanical testing, the "ground truth" is defined by the objective performance criteria outlined in the ASTM standards (e.g., load capacity, resistance to fatigue, acceptable deformation). The reported performance is compared directly to these objective, quantifiable standards, often against the performance of predicate devices.
- For biocompatibility, the "ground truth" is compliance with ISO 10993-1, which involves various in-vitro and/or in-vivo tests to assess biological responses to the device materials.
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Sample Size for the Training Set:
- This question is not applicable. There is no "training set" in the context of mechanical or biocompatibility testing for a physical implant device like the NEST-C Interbody System. These are not AI algorithms that learn from data.
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How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as above. There is no training set for this device's non-clinical evaluations.
In summary, the provided document details a 510(k) submission for a physical medical implant. The "acceptance criteria" and "study" described are focused on engineering performance (mechanical testing) and biological safety (biocompatibility) to demonstrate substantial equivalence to existing legally marketed devices, rather than clinical efficacy studies involving human patient data, expert interpretations, or AI algorithm performance.
§ 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.