(82 days)
CALTRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or created from traumatic injury to the bone. The pellets resorbs and is replaced with new bone during the healing process. When used in the spine, the device is limited to posterolateral fusion procedures only.
The CALTRIX Resorbable Bone Void Filler are made of high purity pharmaceutical grade calcium sulfate. It is bio-degradable, biocompatible and radiopaque pellets. CALTRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CALTRIX Resorbable Bone Void Filler, structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria for performance beyond conforming to standards. It states the device "conforms to applicable standards." The "reported device performance" is primarily presented as meeting these standards and having similar performance characteristics to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Biocompatibility | Conforms to ISO 10993 series: Biological evaluation of medical devices | Device is "bio-degradable, biocompatible." Conforms to ISO 10993 series. |
| Material Purity | Conforms to ASTM F2224-03: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants | Made of "high purity pharmaceutical grade calcium sulfate." Conforms to ASTM F2224-03. |
| Sterilization | Conforms to ANSI/AAMI/ISO 11137 Sterilization of Health Care Products - Radiation Sterilization | Supplied sterile. Conforms to ANSI/AAMI/ISO 11137. |
| Resorption & Bone Growth | (Implied: Resorbs and is replaced by new bone within a clinically acceptable timeframe, and acts as an osteoconductive scaffold.) | "It is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process." |
| Safety & Effectiveness | (Implied: No new questions of safety or effectiveness compared to the predicate device.) | "Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." "Substantially equivalent to the predicate devices." |
| Intended Use | (Implied: Device meets the requirements for its indicated uses.) | Meets the stated intended use: "to fill bony void or gaps of the skeletal system... that are not intrinsic to the stability of the bone structure," with specific limitations for spinal use. |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "bench testing contained in this submission." However, it does not specify any sample sizes for this testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). The study primarily relies on demonstrating conformity to existing standards and comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no information provided in the text regarding the number or qualifications of experts used to establish a ground truth for any test set. The submission focuses on compliance with established material and sterilization standards, and substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set or human-derived data analysis requiring adjudication, there is no information on any adjudication method.
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
This section is not applicable. The device described is a medical implant (bone void filler), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's effectiveness and safety is primarily based on:
- Adherence to recognized industry standards: ISO 10993, ASTM F2224-03, ANSI/AAMI/ISO 11137.
- Demonstrated material properties: "high purity pharmaceutical grade calcium sulfate," "bio-degradable, biocompatible, and radiopaque pellets," "osteoconductive," "resorbed in approximately 14 weeks and be replaced by new bone."
- Substantial equivalence to a legally marketed predicate device: "Osteo-Link Bone Void Filler Pellets (K060809)." The performance and safety profile of the predicate device serves as an established baseline.
8. The Sample Size for the Training Set
There is no mention of a training set. This device is a physical product, not an AI model, and therefore the concept of a training set does not apply in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is 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.