(155 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™ consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Cem-Ostetic™ forms a paste when mixed with sterile distilled water. When 4 centimeter cubes (cc) of water are mixed with 10 cc of powder, the paste becomes hard after 5 minutes. Both powder and water are supplied pre-measured in separate containers. To prepare the putty, the water is first poured into the jar containing the powder and mixed with it for 60 seconds. For the next two minutes, the putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). The putty will harden on average within 5 minutes of contact between powder and water. The Cem-Ostetic™ powder and the water are supplied sterile for single patient use only.
This document describes a 510(k) submission for the Cem-Ostetic™ Bone Void Filler. This is a medical device and not an AI/ML powered device. As such, the information requested, such as acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, are not applicable in the context of this traditional medical device submission.
The provided text focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for many non-AI medical devices. Key aspects of this submission are:
1. Acceptance Criteria and Reported Device Performance:
Not applicable in the context of an AI/ML device. For Cem-Ostetic™, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices (OsteoSet BVF Kit and Osteoplast) based on identical indications for use, contraindications, warnings, precautions, potential adverse events, and similar technical characteristics. The safety and effectiveness are supported by the provided substantial equivalence information, materials data, and test results.
2. Sample size used for the test set and the data provenance:
Not applicable for a medical device of this nature. This device isn't evaluated on a "test set" of data in the same way an AI model would be. Its performance is assessed through material properties testing and comparison to predicate devices, not data analysis of a specific "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for this device typically involves material science testing (e.g., setting time, mechanical strength, biocompatibility), which is evaluated by engineers and scientists, not clinical experts establishing a diagnosis from a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 a bone void filler, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of traditional medical device, ground truth is established through:
- Material Science Testing: Evaluating properties like setting time, compressive strength, radio-opacity, and biocompatibility according to recognized standards.
- Biocompatibility Studies: In-vitro and/or in-vivo testing to ensure the material does not elicit adverse biological responses.
- Clinical Experience/Literature Review: Leveraging existing data and knowledge about the predicate devices and the behavior of similar materials in the body.
8. The sample size for the training set:
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable.
§ 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.