(71 days)
The EndoLIF® On-Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® On-Cage are to be used with autogenous bone and implanted via a posterior or posterolateral approach. The EndoLIF® On-Cage is to be used with a supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an EndoLIF® On-Cage.
Not Found
The provided document is an FDA 510(k) clearance letter for the EndoLIF On-Cage, an intervertebral body fusion device. This type of document declares substantial equivalence to a legally marketed predicate device, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria for analytical or clinical performance.
FDA 510(k) clearances typically focus on establishing that a new device is as safe and effective as an existing, legally marketed device (predicate device). This is primarily achieved through comparisons of technological characteristics, materials, and indications for use. Performance data, while sometimes included, is not typically presented in a format that would allow for the detailed breakdown requested in your prompt (e.g., specific acceptance criteria, sample sizes, ground truth methodology for AI/software devices).
Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because this information is not present in this regulatory document.
The document indicates:
- Device Name: EndoLIF On-Cage
- Regulation Name: Intervertebral body fusion device
- Regulatory Class: Class II
- Product Code: MAX
- Indications for Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. To be used with autogenous bone and implanted via a posterior or posterolateral approach, and with a supplemental FDA cleared fixation.
For medical devices, especially implants like this, the "acceptance criteria" and "proof" typically involve:
- Biocompatibility testing
- Mechanical testing (e.g., fatigue strength, compressive strength, torsional strength) to ensure the device can withstand the forces it will experience in the body.
- Sterilization validation
- Bench testing comparing the new device's engineering properties to the predicate device.
- Animal studies or cadaveric studies (less common for 510(k) if predicate comparison is strong).
- Clinical data (often from the predicate device or a literature review, or specific clinical studies if novel features necessitate it, though not always required for 510(k) if substantial equivalence can be shown otherwise).
However, the specific quantitative details you requested for a study proving the device meets acceptance criteria (especially involving terms like "test set," "ground truth," "MRMC," and "AI/standalone performance") are typically relevant for AI/ML-driven software as a medical device (SaMD) or diagnostic devices, which this intervertebral cage is not. The provided document is for a physical implant.
§ 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.