Search Results

Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)

Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.

The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.

It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.

The provided document is a 510(k) summary for a medical device called "Synthetic Bone Graft Particulate." It focuses on demonstrating substantial equivalence to a predicate device ("PerioGlas - Bioglass Bone Graft Particulate") for regulatory clearance.

This document does not contain acceptance criteria or study details for an AI/ML-driven device's performance. The "performance data" section (Section 7) describes non-clinical tests (sterilization, shelf-life, biocompatibility, chemical/physical properties) and an animal study for the bone graft material itself, not for an AI/ML system.

Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device. The device described in the document is a physical medical implant (synthetic bone graft particulate), not an AI/ML software or system.

Ask a specific question about this device

DZ-Tabone Intervertebral Body Fusion Device can be divided into two types, CIF-PTA and LIF-PTA.

The CIF-PTA is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-Tl. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The CIF-PTA is intended for use with supplemental fixation systems and with autogenous bone graft. The CIF-PTA is implanted via an anterior approach.

The LIF-PTA is 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 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic pam with degeneration of the disc confirmed by history and radiographic studies. 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. The LIF-PTA is implanted using a posterior approach and is intended to be used in pairs with supplemental fixation.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios.

DZ-Tabone Intervertebral Body Fusion Device is a single device manufactured wholly from tantalum metallic material. It has a convex structure on the upper and lower surfaces, and a block structure as a whole. The device has a trabecular porous structure with a central bone graft window, facilitating vertebral fusion through bone ingrowth and providing stable support between vertebrae to maintain intervertebral space height.

The device intends to be used for spinal fusion surgery for patients with degenerative disc diseases, vertebral slippage, and instability of vertebrae. The surgery involves fusing one or two adjacent vertebral segments, with the option to implant in the cervical spine (C2-T1) or lumbar spine (L2-S1) vertebral gaps. It aims to restore the lost height due to vertebral lesions and is used in conjunction with an internal fixation system.

The Device is sterilized by irradiation and provided in a sterile form. These implants are intended for single use only and must not be reused under any circumstances.

This document describes the premarket notification (510(k)) for the DZ-Tabone™ Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing a new, independent set of acceptance criteria based on a clinical study of the device's performance. Therefore, the information requested can only be partially provided based on the content of this FDA clearance letter.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific quantitative acceptance criteria in terms of clinical performance (e.g., fusion rates, pain reduction scores) or report the device's performance against such criteria. Instead, the "acceptance criteria" are related to non-clinical testing designed to demonstrate substantial equivalence to predicate devices. The reported device performance is therefore in terms of meeting these non-clinical standards and demonstrating comparable characteristics.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of clinical performance. The "tests" mentioned are non-clinical (mechanical, biocompatibility, sterilization, endotoxin) performed on samples of the device itself. Specific sample sizes for these engineering and lab tests are not provided in this summary but would have been part of the full 510(k) submission.
• Data Provenance: The data provenance for the non-clinical tests is the manufacturer, Shenzhen Dazhou Medical Technology Co., Ltd. The document refers to "test results," implying these were prospective tests specifically conducted for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as no clinical test set requiring expert ground truth establishment is described for this 510(k) submission. The FDA clearance is based on non-clinical data demonstrating substantial equivalence.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication is described in this document.

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 device is an intervertebral body fusion device, not an AI or imaging diagnostic tool. Therefore, a MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO) and regulatory guidance (e.g., FDA guidance for sterility).

8. The Sample Size for the Training Set:

Not applicable, as there is no specific "training set" in the context of this 510(k) submission for a physical medical device. Device design and validation processes rely on engineering principles, materials science, and testing against known standards, not machine learning training sets.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as above.

In summary:

This FDA 510(k) clearance is based on demonstrating that the DZ-Tabone™ Intervertebral Body Fusion Device is substantially equivalent to legally marketed predicate devices. This is primarily achieved through non-clinical testing that confirms the new device's material properties, mechanical performance, biocompatibility, and sterility meet established standards and are comparable to those of the predicate devices. The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." Therefore, information related to clinical studies, expert-established ground truths, or AI performance metrics requested in your prompt is not found within this clearance letter.

Ask a specific question about this device