(110 days)
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram ™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
Apaceram ™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram ™ is provided sterile for single patient use.
The provided text is a 510(k) Summary for the Apaceram™ Bone Graft Substitute, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It is important to note that a 510(k) summary for a bone void filler generally does not contain detailed information about a study with acceptance criteria in the context of an AI/algorithm-driven device's performance measurement. The data presented here pertains to the safety and efficacy of the physical bone graft substitute material itself, not an AI or software component.
Therefore, many of the requested points regarding sample sizes, expert adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as they are not relevant to the type of device being described.
However, I can extract the information that is present and relevant to the device's acceptance criteria and the basis for its approval.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a 510(k) device are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the new device has the same intended use and the same technological characteristics as the predicate device(s), or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness, and is as safe and effective as the predicate device(s).
For Apaceram™ Bone Graft Substitute, the "acceptance criteria" are implicitly met by demonstrating similar design, material composition, final product configurations, and function to the predicate devices.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance / Basis for Equivalence |
|---|---|
| Intended Use: Similar to predicate device(s). | Apaceram™ is intended for use as a bone void filler for bony voids, gaps, or defects (extremities, spine, or pelvis) caused by degeneration, trauma or surgery, and as a bone graft extender. This aligns with typical indications for bone void fillers. |
| Technological Characteristics: Similar design, materials, function, and performance to predicate device(s). | Apaceram™ and the predicate devices (K033722, ApaPore®; K051774, MBCP™) are similar in: |
- Design: Osteoconductive bone void filler.
- Material Composition: Calcium salts (specifically hydroxyapatite for Apaceram™).
- Final Product Configurations: Provided in various particulate and shaped sizes.
- Function: Provide an interconnected, highly porous scaffold environment for new bone ingrowth; resorbed and replaced with bone during healing. |
| Safety and Biocompatibility: Does not raise new questions of safety and effectiveness. | "The safety and biocompatibility testing performed by Pentax and a long history of safe clinical use of this material support the safety and effectiveness of Apaceram™ and its equivalence to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in this context. The 510(k) summary does not describe a "test set" in the sense of a dataset used to evaluate an AI algorithm. Instead, it refers to biocompatibility testing and clinical use history of similar materials.
- Data Provenance: The document mentions "safety and biocompatibility testing performed by Pentax" (the submitter) and "a long history of safe clinical use of this material." The specific countries of origin or whether this refers to prospective or retrospective studies are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as it's not relevant to a 510(k) submission for a bone graft substitute. Ground truth establishment by experts in the context of an AI algorithm's performance is not part of this documentation.
4. Adjudication method for the test set
- Not applicable for this type of medical device submission.
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 physical bone graft substitute and does not involve AI or human readers in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a traditional 510(k) bone graft substitute, "ground truth" for proving substantial equivalence primarily relies on:
- Material Characterization: Chemical composition analysis, physical properties (porosity, degradation rate).
- Biocompatibility Testing: In vitro and in vivo studies to assess biological response (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation effects).
- Functional Equivalence: Demonstrated ability to act as an osteoconductive scaffold, promote bone ingrowth, and resorb over time, often through animal studies or referencing established knowledge of the material.
- Clinical History/Outcomes Data (of the material/predicate devices): Referencing established safety and effectiveness through the long history of clinical use of similar materials and predicate devices.
8. The sample size for the training set
- Not applicable as this is not an AI/algorithm-driven device.
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.