(137 days)
The STALIF MIDLINE™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIF MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF MIDLINE™ system must be used with bone grafting material (autograft only).
The STALIF MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIFTM TT (K073109) to include a modified anti-back out feature and additional sizes.
The provided text describes the STALIF MIDLINE™ intervertebral body fusion device and its substantial equivalence to a predicate device (STALIF™ TT, K073109). The information primarily focuses on the device's indications for use, description, and mechanical performance testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Equivalence | Static Compression (ASTM F2077) | "mechanically equivalent to predicate devices" |
| Dynamic Compression (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Static Torsion (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Dynamic Torsion (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Static Compression-Shear (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Dynamic Compression-Shear (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Static Subsidence (ASTM F2267) | "mechanically equivalent to predicate devices" | |
| Functional Equivalence | Same indications for use as predicate (K073109) | Met |
| Similar design to predicate (K073109) | Met (modified anti-back out feature and additional sizes) | |
| Similar function to predicate (K073109) | Met | |
| Similar materials to predicate (K073109) | Met | |
| Safety and Effectiveness | Substantial equivalence to predicate device (K073109) | Determined by FDA |
The study that proves the device meets the acceptance criteria is the mechanical testing performed in accordance with ASTM F2077 and ASTM F2267. This testing indicated that the STALIF MIDLINE™ is "mechanically equivalent to predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the mechanical tests, the type of data (human or animal), or its provenance. It only states that "Testing performed in accordance with ASTM F2077... and ASTM F2267... indicates the STALIF MIDLINE™ is mechanically equivalent to predicate devices." These ASTM standards refer to in-vitro mechanical testing of intervertebral body fusion devices, not clinical trials with patient data.
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)
This is not applicable as the study involves mechanical testing of a medical device, not a performance study that requires expert review of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no human interpretation of data described in the mechanical testing.
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
This is not applicable. The provided document concerns the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on mechanical equivalence, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance of the STALIF MIDLINE™ device is established by the specifications and performance characteristics defined in the ASTM F2077 and ASTM F2267 standards, and by comparison to the established mechanical performance of the predicate device (STALIF™ TT, K073109).
8. The sample size for the training set
This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an algorithm. The "ground truth" for the mechanical testing is based on established engineering standards for medical devices and the predicate device's 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.