(64 days)
Synthes chronOS™ is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS™ is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOS™ resorbs and is replaced with bone during the healing process.
Synthes chronOS™ is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP). Synthes chronOS™ is resorbed and replaced by new bone during the healing process. The pore structure of chronOS™ provides a matrix for the ingrowth of bone. chronOS™ is provided sterile in a double sterile pack. It is available in various forms including granules, blocks, wedges and cylinders.
Synthes chronOS™ may be packaged with a perfusion syringe that is used to mix the bone void filler with the patient's blood components and/or bone marrow.
This document is a 510(k) summary for the Synthes chronOS™ bone void filler. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Crucially, this document does not contain information on acceptance criteria or a study proving device performance against such criteria.
The 510(k) process is a premarket notification to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate.
Therefore, the requested information cannot be extracted from the provided text.
Here's why and what might be found in a different type of submission or document:
- Acceptance Criteria and Reported Device Performance: These are typically established during device development and verified through design validation studies, which could include clinical trials, animal studies, or bench testing. A 510(k) summary generally refers to these studies if they were used to demonstrate substantial equivalence, but it doesn't usually present the raw data, acceptance criteria, or detailed results in this format. The 510(k) focuses on comparison to a predicate, not necessarily detailed performance metrics against predefined criteria in the same way a PMA (Premarket Approval) might.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a detailed study report. While studies would have been conducted to support the safety and effectiveness claims, the 510(k) summary is a high-level overview for regulatory purposes.
- Training Set Sample Size and Ground Truth: This information would be relevant for machine learning-based devices, which this particular product (a bone void filler) is not.
To find the requested information, one would typically need to consult:
- Clinical Study Reports: If clinical studies were conducted to support the 510(k) (which is less common for "substantially equivalent" devices unless significant new technological characteristics are present), these reports would contain the details.
- Design Validation Documentation: Internal company documents detailing the testing and validation performed.
- PMA Submissions: Devices requiring a PMA go through a more rigorous review process, and their submissions contain extensive data on safety and effectiveness, including detailed acceptance criteria and study results.
- Summary of Safety and Effectiveness Data (SSED): For PMA-approved devices, the FDA publishes these summaries, which detail the studies and findings.
In summary, the provided text does not contain the information requested about acceptance criteria and detailed study performance.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.