(17 days)
Cem-Ostetic™ is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.
Cem-Ostetic™ Putty Injection Kit consists of a syringe filled with calcium salts. Once mixed with water, the calcium salts can be injected into a bone void or defect with a trocar. Cem-Ostetic is supplied sterile for single patient use only.
The provided text is a 510(k) summary for the Cem-Ostetic™ Injection Kit. This document focuses on establishing substantial equivalence to a legally marketed predicate device (Cem-Ostetic™ Putty) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel AI/ML device.
Therefore, the requested information elements (acceptance criteria, device performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and ground truth establishment for training set) are not applicable or not present in the provided document.
The document states:
"The safety and effectiveness of Cem-Ostetic™ Injection Kit are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Premarket Notification."
This implies that the "study" for acceptance involves demonstrating that the new injection kit is substantially equivalent to the existing Cem-Ostetic™ Putty. The "acceptance criteria" are met by showing that:
- Identical Indications-for-Use: Both devices are intended to fill voids and gaps in bone structures (extremities, spine, pelvis, cranium), can be shaped by hand or injected, provide temporary support, are radio-opaque, biocompatible, and resorbable.
- Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: The injection kit shares the same safety profiles as the predicate.
- Very Similar Technical Characteristics: While the injection kit introduces a new delivery method (syringe and trocar), the core material (calcium salts mixed with water forming a paste) is fundamentally the same as the predicate putty.
The document does not detail specific "test results" or "materials data" beyond this declaration of similarity. It is a regulatory submission for substantial equivalence, not a detailed scientific paper on device performance in a clinical or experimental study context.
§ 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.