(76 days)
Cementek® is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® resorbs and is replaced with bone during the healing process.
As a malleable bone substitute, Cementek® is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced as a paste into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in a apatitic calcium phosphate cement. Cementek is marketed in two different dosages; Cementek® 20 produces 8cc of paste and Cementek® 40 produces 16cc.
This document describes a 510(k) premarket notification for a bone void filler device, Cementek®. The focus of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish strict acceptance criteria through a comprehensive clinical study with performance metrics in the way a PMA (Premarket Approval) would.
Therefore, the provided text does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested information regarding study design elements like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.
The "study" mentioned is an "animal model" that performed similarly to a predicate device, which is a comparative assessment rather than a performance study against specific acceptance criteria.
However, I can extract the information that is present and indicate what is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical Form: (Equivalent to predicate) | Malleable bone substitute, packaged as solid and liquid phases, mixed in operating room to form a paste. |
| How Supplied: (Equivalent to predicate) | Marketed in two dosages: Cementek® 20 (8cc paste) and Cementek® 40 (16cc paste). |
| Compressive Strength: (Equivalent to predicate) | Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Porosity: (Equivalent to predicate) | Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Average Pore Size: (Equivalent to predicate) | Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Composition of Final Product: (Equivalent to predicate) | Apatitic calcium phosphate cement (after athermic reaction). Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Indications: (Equivalent to predicate) | Bone void filler for voids/gaps not intrinsic to stability, for surgically created or traumatic osseous defects in skeletal system (extremities, spine, pelvis). Resorbs and is replaced by bone. Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Animal Model Performance: (Similar to predicate) | Performed similarly to a-BSM in an animal model. |
Missing Information: Specific quantitative acceptance criteria (e.g., "compressive strength > X MPa") are not stated. The performance is reported in terms of equivalence or similarity to predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided text. The "animal model" is mentioned, but no details on the number or type of animals are given.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no human expert-based ground truth establishment for a test set is mentioned. The comparison is against predicate devices and animal model results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable; no information on adjudication method is provided.
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 or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating equivalence appears to be derived from comparative testing against predicate devices (for physical properties) and results from an animal model (for in-vivo performance/resorption, implied). No specific pathology or outcomes data from human studies are detailed, as is typical for a 510(k) submission focused on equivalence.
8. The sample size for the training set:
- Not applicable or not specified. This is a medical device, not an AI model requiring a training set. If "training set" refers to data used to develop the device's properties, no specific sample sizes are mentioned.
9. How the ground truth for the training set was established:
- Not applicable for a medical device in the context of AI. For the device itself, the properties (e.g., composition, strength) are established through standard materials science and biological testing, likely compared to known standards or predicate device properties.
§ 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.