(129 days)
LOSPA IS PLIF&ALIF Cages are indicated for use with autogenous bone graft as intervertebral body fusion devices at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Patients should be skeletally mature and have had six months of non-operative treatment.
Devices are intended to be implanted via an open, posterior approach and used with autogenous bone and supplemental fixation.
LOSPA IS ACIF Cage is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in sketally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
Patients should have received at least six weeks of non-operative treatment with the device.
Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation.
The LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices is available in various heights and Lordotic configurations with an open architecture to accept packing of bone graft material. The design features are common with the design features of all the predicate devices as described below,
- Straight and wedge / Lordotic designs to match vertebral anatomy
- Adequate interior graft space for optimal bony integration
- Superior and inferior ridges designed to prevent implant migration
- Similar structural characteristics, open architecture to accept packing of autograft
- PEEK Cages (ASTM F2026) with radio-dense markers (Tantalum - ASTM F 560) for optimum fluoroscopic placement and post operative examination
- Available in multitude of similar sizes and lordotic
LOSPA IS PLIF Cage
- Three versions are available according to the lordotic angles (0°, 4°, 8°)
- It has various heights (8~16 mm) and lengths (22, 25, 28, 31, 34 mm)
LOSPA IS ALIF Cage
- Four versions are available according to the lordotic angles (6°, 8°, 12°, 15°)
- It has various heights (8~16 mm) and lengths (22, 25, 28, 31, 34 mm)
LOSPA IS ACIF Cage
- Available in a convex version with 5° lordotic angle.
- It has various heights (5~12 mm), widths (12, 14 mm) and depths (14, 16 mm)
LOSPA IS SPINAL SYSTEM INSTRUMENTATION
The LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices instrumentation consists of set of accessories to be used with LOSPA Cage implants. The instrumentation is classified as Class II. Class II instrumentations includes implant specific instrumentations. The instruments are designed similar to devices already in market and is simple, conventional, and accurate. The parts of the instruments are made of stainless steel and polymers which are biocompatible and used in medical industry for decades. The instrumentation is used for their respective procedures by qualified orthopedic surgeons.
The provided document is a 510(k) Premarket Notification from the FDA regarding the LOSPA IS Spinal System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study. Therefore, the requested information elements such as a table of acceptance criteria, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not available within this document.
However, the document does mention "Performance Data" which refers to mechanical testing. Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria. Instead, it states that the device "performed either similar or better than comparable predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrated substantial equivalence through mechanical testing methods described in ASTM F 2077 and ASTM F 2267. | The static and dynamic testing's, subsidence and expulsion results demonstrated that the subject device performed either similar or better than comparable predicate devices. |
| No new issues of safety or efficacy raised due to differences in technological characteristics. | Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any "test set" in the context of clinical data or human-in-the-loop performance. The performance data mentioned refers to mechanical testing of the device itself. Data provenance is not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth based on expert review is mentioned, as the study described is mechanical testing.
4. Adjudication method for the test set
Not applicable. No adjudication method is mentioned, as the study described is 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
No. An MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence via mechanical testing for an interbody fusion device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a spinal implant.
7. The type of ground truth used
For the mechanical testing referenced, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate devices and the ASTM standards. The document implicitly uses the performance of predicate devices as a benchmark for "similarity" or "better" performance.
8. The sample size for the training set
Not applicable. This is an implantable medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does provide regarding performance:
The "Performance Data" section (Page 5 of 6, K151408) indicates that mechanical testing was performed according to ASTM F 2077 and ASTM F 2267 standards. The tests included:
- Static axial compression
- Static compression shear
- Static torsion
- Dynamic axial compression
- Dynamic compression shear
- Dynamic torsion
- Subsidence testing
- Expulsion testing
The results of these tests demonstrated that the subject device (LOSPA IS Spinal System) performed "either similar or better than comparable predicate devices," thereby establishing substantial equivalence for performance. The document concludes that any differences in technological characteristics do not raise new issues of safety or efficacy.
§ 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.