(64 days)
LOSPA IS PLIF/T-PLIF & ALIF & TLIF & DLIF Cages are indicated for use with autogenous bone graft as an intervertebral body fusion device 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 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 or anterior approach and used with autogenous bone and supplemental fixation.
LOSPA IS TLIF & DLIF Interbody fusion devices are 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 the predicate devices. Straight and wedge / Lordotic designs to match vertebral anatomy, Large interior graft space for optimal bony integration, Superior and inferior ridges designed to prevent implant migration, PEEK Cages with Tantalum markers for optimum fluoroscopic placement and post operative examination, Available in multitude of similar sizes to suit the individual pathology and anatomic condition of the patient. It is made of PEEK (ASTM F2026) & Tantalum (ASTM F560).
LOSPA IS TLIF Cage is available in
- . Two versions are available according to the lordotic angles (0° & 7°).
- It has various heights (8~16 mm) and lengths (24, 29, 32, 35 mm).
- Two shapes, LOSPA IS TLIF Cage & LOSPA IS TLIF Cage B type.
LOSPA IS DLIF Cage is available in
- Four versions are available according to the lordotic angles (0°, 6°, 12° & 18°). ●
- It has various heights (8~16 mm), widths (18 & 22 mm) and lengths (40, 45, 50, 55, 60 mm).
The provided text is a 510(k) summary for the LOSPA IS TLIF & DLIF Cages. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting detailed acceptance criteria and a study report with performance metrics for software or AI devices.
Therefore, many of the requested categories for acceptance criteria and a study proving device meets those criteria are not applicable or cannot be extracted from this particular document. The device in question is an intervertebral body fusion device, a physical implant, not a software or AI diagnostic tool.
Here's a breakdown of what can and cannot be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (or N/A) | Notes |
|---|---|---|
| Mechanical Performance | Demonstrated through static axial compression and static compression shear testing. | The document states, "The static results demonstrated that the subject devices are expected to be as safe and as effective as the predicate devices." Specific numerical acceptance criteria or performance values are not provided. |
| Material Biocompatibility | Made of PEEK (ASTM F2026) & Tantalum (ASTM F560). Parts of instruments made of stainless steel and polymers. All materials are biocompatible and cleared for use in PMN. | Compliance with established ASTM standards for materials. |
| Sterilization | Steam sterilization validated as per ISO 17665-1 for non-sterile devices. Gamma sterilization validated as per ISO 11137-1 & ISO 11137-2 for sterile components. | Compliance with ISO standards. |
| Packaging & Shelf Life | Packaging subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards (accelerated aging as per ASTM F1980). | Compliance with ISO and ASTM standards. |
| Pyrogenicity | Pyrogen Testing performed. | Test was conducted; specific results not detailed but implied to meet requirements for safety. |
| Indications for Use (Clinical Equivalence) | "LOSPA IS PLIF/T-PLIF & ALIF & TLIF & DLIF Cages are indicated for use with autogenous bone graft as an intervertebral body fusion device 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 at the involved level(s)." | This is the intended use for which substantial equivalence was sought and granted. The performance testing supports this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes mechanical and sterilization testing of a physical medical device, not a diagnostic or AI device that would utilize a "test set" of patient data. The "test set" refers to the physical devices (e.g., specific cage sizes/configurations) subjected to mechanical, sterilization, and pyrogenicity tests. The document does not specify a numerical sample size for these hardware tests, stating "performance testing was carried out." There is no patient data provenance as it's not a clinical study on 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)
- Not Applicable. This is not a study requiring expert readers or ground truth establishment in the context of diagnostic performance. Technical experts would have designed and critically reviewed the engineering, material, and sterilization tests, but their number and specific qualifications are not detailed in this regulatory summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for clinical studies or diagnostic performance evaluations where disagreement among experts needs resolution. This document describes physical device 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
- Not Applicable. This is not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this type of device is primarily defined by engineering specifications, material science standards (e.g., ASTM), and regulatory standards (e.g., ISO for sterilization). For example, for mechanical testing, the ground truth is the specified load a device must withstand. For material composition, it's the chemical and physical properties required by the ASTM standard. For sterilization, it's the Sterility Assurance Level (SAL) defined by ISO standards. It's not a clinical "ground truth" derived from patient outcomes or expert consensus on images.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that utilizes a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth establishment for one.
§ 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.