(168 days)
BoneMedik and BoneMedik-S are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone graft substitute that resorbs and is replaced with bone during the healing process.
BoneMedik and BoneMedik-S are coralline hydroxyapatite bone void fillers. They are similar except that BoneMedik-S contains about one percent silicon. Both are osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite. Once implanted the porous hydroxyapatite is resorbed and the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the BoneMedik and BoneMedik-S surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue growing into the space previously occupied by the implant.
This document describes the premarket notification (510(k)) for the BoneMedik and BoneMedik-S bone void fillers. It does not contain a standalone study to prove that the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics like sensitivity, specificity, AUC for an AI/diagnostic device). Instead, this is a regulatory submission for a medical device seeking clearance based on "substantial equivalence" to existing legally marketed devices, not on a new clinical performance study demonstrating efficacy with acceptance criteria and a detailed statistical analysis of a test set.
However, I can extract the information provided about the tests performed and what they aimed to achieve, which can be interpreted as demonstrating the device meets certain performance standards relevant to its safety and basic function, though not in the context of an AI/diagnostic device's performance study.
Here's a breakdown of the information based on your request, with the caveat that the prompt's structure is better suited for AI/diagnostic device studies:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/diagnostic device, there are no "acceptance criteria" in terms of classification metrics (sensitivity, specificity). Instead, the device met various standards and passed specific tests.
| Acceptance Criteria/Standard Met | Reported Device Performance |
|---|---|
| Performance Testing (Bench): | |
| Extraction material test | Met criteria (implicit pass for 510(k) clearance) |
| Heavy metal contents | Met criteria (implicit pass for 510(k) clearance) |
| Ca/P ratio | Met criteria (implicit pass for 510(k) clearance) |
| Shape | Met criteria (implicit pass for 510(k) clearance) |
| Size | Met criteria (implicit pass for 510(k) clearance) |
| Packaging | Met criteria (implicit pass for 510(k) clearance) |
| Compressive strength | Met criteria (implicit pass for 510(k) clearance) |
| Animal Testing (Implantation): | |
| Macroscopic observations of bony ingrowth | Demonstrated bony ingrowth (implicit pass for 510(k) clearance) |
| Microscopic observations of bony ingrowth | Demonstrated bony ingrowth (implicit pass for 510(k) clearance) |
| X-ray photos | Demonstrated bony ingrowth (implicit pass for 510(k) clearance) |
| X-ray diffraction patterns | Demonstrated characteristics consistent with hydroxyapatite and bony ingrowth (implicit pass for 510(k) clearance) |
| Biocompatibility (ISO 10993): | |
| Cytotoxicity | Met ISO 10993 standards |
| Sensitization | Met ISO 10993 standards |
| Irritation | Met ISO 10993 standards |
| Acute systemic toxicity | Met ISO 10993 standards |
| Sterilization (Gamma Radiation): | |
| Sterility Assurance Level (SAL) | Validated to provide a minimum SAL of 10⁻⁶ |
| General Standards: | |
| ISO 10993 (Biocompatibility) | Met |
| ISO 11137 (Sterilization) | Met |
| ISO 13409 (Sterilization validation) | Met |
| ISO 13779-1:2000 (Implants for Surgery) | Met |
| FDA Guidance Document: "Resorbable Calcium Salt Bone Void Filler Device, Guidance for Industry and FDA" | Studies designed according to applicable sections of this guidance document. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the "test set" in terms of number of samples for each test type (e.g., number of animals for implantation, number of samples for mechanical testing). It refers to "studies described in this document" for various tests.
- Data Provenance: Not explicitly stated, but the submitter is Meta Biomed Co., Ltd., Cheongwongun, Chungbuk, Korea. The studies were likely performed in Korea or under their supervision. They are described as "studies used to provide the data required in the guidance document." These would be considered prospective tests performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not relevant or provided for this device submission. The tests performed (e.g., chemical analysis, mechanical testing, animal implantation assessment, biocompatibility assays) do not typically rely on "experts" establishing a "ground truth" through consensus in the way an AI diagnostic algorithm's image interpretation would. The 'ground truth' comes from objective measurements, histological analysis, and adherence to established scientific and regulatory protocols.
4. Adjudication Method for the Test Set
Not relevant or provided for this type of device and study. Adjudication methods like "2+1" are used for expert review in diagnostic studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/diagnostic device, so an MRMC study is not applicable. The device is a bone void filler material, not an imaging interpretation tool or diagnostic algorithm that would assist human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context is established through:
- Established scientific methodologies: For chemical composition (Ca/P ratio, heavy metals), physical properties (shape, size, compressive strength), and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
- Histopathology and imaging: For animal implantation tests (macroscopic and microscopic observations of bony ingrowth, X-ray photos and diffraction patterns).
- Validation protocols: For sterility assurance levels.
8. The Sample Size for the Training Set
Not applicable. This device is a material, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.