(143 days)
The Spine 360 Lumbar Interbody Fusion System 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 history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The SHARK implant (PLIF) consists of rectangular blocks with a tapered nose. The BULLSHARK implant (PLIF) is rectangular in shape with a conical nose. Both devices have parallel configurations of various heights.
The TIGER implant (TLIF) consists of banana shaped blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft and facilitate fusion.
The GREAT WHITE implants (ALIF) are oval shaped blocks, which are available in a two lordotic configurations (7° and 13°) of various heights. The hollow cylinders allow for placement of bone graft and facilitate fusion.
Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.
The provided text is a 510(k) summary for the "Spine 360 Interbody Fusion System," which is a medical device. This document focuses on demonstrating substantial equivalence to previously approved devices, not on proving that the device meets specific performance criteria through clinical studies or extensive testing that would generate acceptance criteria and reported performance in the way an AI/software device would.
Therefore, many of the requested elements for an AI or software device (like sample size for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable to this type of device submission.
However, I can extract the information that is relevant to the provided document:
Acceptance Criteria and Device Performance (for Substantial Equivalence)
The core "acceptance criteria" for a 510(k) submission like this is substantial equivalence to predicate devices. This means demonstrating that the new device is as safe and effective as a legally marketed device that is already on the market. The reported "performance" is primarily a comparison of key features and the results of non-clinical (bench) testing against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (demonstrate equivalence to predicates) | Reported Device Performance (Spine 360 System) |
|---|---|---|
| Intended Use | Per 21 CFR 888.3080 (Lumbar Intervertebral Body Fusion) | Per 21 CFR 888.3080 (Lumbar Intervertebral Body Fusion) |
| Material Composition | PEEK materials suitable for surgical implants (e.g., PEEK Optima LT1) | PEEK-OPTIMA LT1 polymer (ASTM F2026), Tantalum (ASTM F560) |
| Bone Graft Cavity | Presence of a bone graft cavity | Yes |
| Ridges | Presence of ridges | Yes |
| X-ray Markers | Presence of X-ray markers | Yes |
| Sterility | Provided non-sterile, steam sterilized at hospital (or gamma sterilized) | Provided non-sterile, steam sterilized at hospital |
| Mechanical Performance (Static Compression) | Meet requirements of ASTM F2077 | Testing performed per ASTM F2077 |
| Mechanical Performance (Dynamic Compression) | Meet requirements of ASTM F2077 | Testing performed per ASTM F2077 |
| Subsidence Resistance | Meet requirements of ASTM F2267 | Testing performed per ASTM F2267 |
| Design Characteristics | Rectangular/conical (PLIF), banana (TLIF), oval (ALIF) shapes with various heights and large bone graft windows. | SHARK (PLIF) - rectangular blocks, tapered nose; BULLSHARK (PLIF) - rectangular, conical nose; TIGER (TLIF) - banana shaped; GREAT WHITE (ALIF) - oval, 7°/13° lordosis. All with bone graft windows. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This is a non-clinical device. The "test set" consists of the physical devices themselves and test coupons for material characterization. The document does not specify a numerical sample size for the mechanical testing, but these tests are typically performed on a statistically relevant number of units.
- Data Provenance: The mechanical tests (static compression, dynamic compression, subsidence) are bench tests conducted in a laboratory setting, not on patient data. The origin of the data is therefore the testing facility. The document does not specify the country of origin of the testing.
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)
- Not Applicable. For a physical implant device, ground truth as it pertains to AI/software evaluation (e.g., expert consensus on medical images) is not relevant. The "ground truth" for material properties and mechanical performance is established by recognized ASTM standards and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical data, which is not part of this device submission.
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
- No. This is a physical interbody fusion system, not an AI or imaging software. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is derived from:
- Material Specifications: Compliance with ASTM F2026 (for PEEK) and ASTM F560 (for Tantalum) standards.
- Mechanical Testing Standards: Adherence to ASTM F2077 (static and dynamic compression) and ASTM F2267 (subsidence) test methods and their implied performance requirements.
- Substantial Equivalence: Comparison against the design, materials, intended use, and performance of legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
Summary of the Study (or Basis for Clearance):
The "study" in this context is the non-clinical testing and comparison to predicate devices for demonstrating substantial equivalence.
- Non-Clinical Test Summary: The application included non-clinical tests:
- Static and dynamic compression testing according to ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices."
- Subsidence testing according to ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression."
- Clinical Test Summary: "No clinical studies were performed."
- Basis for Clearance: The Spine 360 Interbody Fusion System was found "substantially equivalent" to predicate devices (BRANTIGAN I/F CAGE (P960025) and Lucent Straight Intervertebral Body Fusion Device (K072120)) based on:
- Identical intended use (intervertebral body fusion for DDD in lumbar spine).
- Similar design, materials (predominantly PEEK Optima LT1 and tantalum markers), and function.
- Successful completion of non-clinical mechanical testing demonstrating performance comparable to what is expected for such devices and predicates.
§ 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.