(309 days)
The TAURUS PEEK Cages are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The TAURUS PEEK Cage System consists of four different models of interbody fusion devices - TAURUS-P™ Cage, TAURUS-AL (ALIF) Cage, and TAURUS-DL Cage. TAURUS PEEK Cage System is intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The devices consist of PEEK cages of various heights, widths, and lengths, which can be inserted across the disc space between two lumbar vertebral bodies to give support and correction during vertebral bod fusion surgeries. All models have serrations on the superior and inferior surfaces of the implants to aid in fixation. All models are designed with hollow regions in the center to house autograft bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. Radiopaque tantalum markers have been embedded within the implants to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of the devices.
The PEEK material used in the subject interbody cages conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical Implant Applications" and the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications".
This document, a 510(k) Premarket Notification for the TAURUS PEEK Cage System, describes the device and its indications for use, and makes a claim of substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The provided text focuses on the regulatory clearance process for a physical medical implant (intervertebral body fusion device) and demonstrates substantial equivalence based on mechanical performance testing compared to predicate devices, rather than a study evaluating the performance of a software or AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as it pertains to AI/ML device performance. The type of study described in the document is mechanical performance testing for a physical implant, not a clinical or AI/ML performance study.
Here's a breakdown of why I cannot answer the specific AI/ML related questions:
- Acceptance Criteria & Reported Device Performance (Table): The document reports mechanical testing results for the implant (static axial compression bending, static shear compression bending, static torsion, dynamic axial compression fatigue, and subsidence) per ASTM F2077 and ASTM F2267. It states these results "have shown them to be substantially equivalent to the predicate interbody devices." It does not provide specific numerical acceptance criteria or detailed numerical results for AI/ML performance metrics like accuracy, sensitivity, specificity, AUC, etc.
- Sample size for test set and data provenance: Not applicable to this type of mechanical testing.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for mechanical testing is based on physical measurements and engineering standards.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: For mechanical testing, the ground truth is the physical properties and behavior of the device under specific loads, measured against established engineering standards (ASTM F2077, ASTM F2267).
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
In summary, the provided document details the regulatory pathway for a physical medical device (intervertebral cage) based on substantial equivalence and mechanical performance testing, not on the performance evaluation of an AI/ML algorithm.
§ 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.