(192 days)
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
Bond Bone™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
The provided text describes a 510(k) premarket notification for a medical device called Bond Bone™, a synthetic bone grafting material. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with acceptance criteria for device performance in human subjects.
Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this 510(k) submission as no such studies were conducted or reported for this device to prove its performance against acceptance criteria in the traditional sense of a clinical trial. The device's performance is demonstrated through its equivalence to the predicate device.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission demonstrating substantial equivalence to a predicate device, there are no explicit "acceptance criteria" for clinical performance that the device had to meet. Instead, the acceptance criteria are implicitly that the new device's chemical and physical characteristics must be equivalent to those of the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Bond Bone™) |
|---|---|
| Equivalent Chemical Composition | Equivalent to predicate device |
| Equivalent Phase Composition | Equivalent to predicate device |
| Equivalent Trace of Impurities | Equivalent to predicate device |
| Equivalent Density and Porosity | Equivalent to predicate device |
| Equivalent Particle Size | Equivalent to predicate device |
| Equivalent Morphology | Equivalent to predicate device |
| Equivalent Setting Time and Reaction Temperature | Equivalent to predicate device |
| Equivalent Compressive Strength and Elastic Modulus | Equivalent to predicate device |
| Equivalent pH Analysis | Equivalent to predicate device |
| Equivalent Dissolution Rate | Equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The submission focuses on physical and chemical testing, not clinical performance with a "test set" of patient data.
- Data Provenance: Not applicable for clinical data. The tests were likely conducted in a laboratory setting, presumably by the manufacturer (MIS Implants Technologies Ltd. or its contracted labs). The country of origin of the company is Israel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" established by human experts for a clinical test set in this type of submission. The performance assessment was based on objective physical and chemical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or human adjudication was performed.
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 is not an AI/software device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a bone grafting material, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this submission refers to the measured physical and chemical properties of the device, compared to those of the predicate. These are objective laboratory measurements, not ground truth derived from clinical observations.
8. The sample size for the training set
Not applicable. There's no training set for an algorithm as this is a physical medical device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" in this context is a series of chemical and physical performance tests conducted on the Bond Bone™ device. The goal of these tests was to demonstrate that the new Bond Bone™ product is substantially equivalent to its predicate device, Bond Bone™ from Augma Biomaterials Ltd. (K083858).
The text states:
"Bond Bone™ has been tested for a number of chemical and physical characteristics: chemical composition, phase composition, trace of impurities, density and porosity, particle size, morphology, setting time and reaction temperature, compressive strength and elastic modulus, pH analysis and dissolution rate. All these characteristics are equivalent to those of the predicate device."
This series of laboratory tests, comparing the new device's properties to those of the predicate, serves as the evidence that the device meets the (implicit) acceptance criteria for substantial equivalence. The "acceptance criteria" here are that the new device's properties fall within a range considered equivalent to the predicate device's established properties. The study concludes that based on these tests, the device has the "same performance characteristics" as the predicate device.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.