Search Results

The Hubble II Lumbar Interbody Fusion 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 at the involved level(s). Hubble II System implants are to be used with autogenous bone graft. Patients should be sketally mature and have at least six months of non-operative treatment. The Hubble II System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Hubble II Lumbar Interbody Fusion System consist of 3 designs, PLIF & PLIF BS, TLIF and OLIF. The PLIF and TLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F560 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

This document is a 510(k) Premarket Notification from the FDA for a medical device called Hubble II, an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study proving device performance against such criteria.

The crucial sentence that indicates this is:

"As there are no changes in design or materials or manufacturing processes, no new performance testing was required. No clinical or animal studies were performed."

This means the submission relies on the established performance of the legally marketed predicate device (Twin Peaks) and does not present new performance data for Hubble II itself. Therefore, I cannot extract the requested information.

Reason for not providing the requested information: The provided document is a 510(k) Premarket Notification for a medical device. This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the subject device meets specific acceptance criteria based on new performance studies. The document explicitly states that "no new performance testing was required" and "no clinical or animal studies were performed" for the Hubble II device due to its identical design, materials, and manufacturing processes to its predicate.

Therefore, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes or data provenance for a test set.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone (algorithm-only) performance studies.
• The type of ground truth used.
• Sample size for a training set or how its ground truth was established, as this device does not involve an algorithm or AI.

The "Performance Testing" section states that the predicate device was tested according to ASTM F2077 and ASTM F2267, including static and dynamic axial compression, static and dynamic compression shear, subsidence, and expulsion. However, these are tests performed on the predicate, not the Hubble II device itself as part of this submission, and no specific performance values are reported for Hubble II against acceptance criteria.

Ask a specific question about this device