(36 days)
ORTHO-ONE is indicated for the adhesion of orthodontic brackets to acid etched enamel.
ORTHO-ONE is a no-mix direct bonding orthodontic adhesive. The micromechanical bond to enamel utilizes the acid etch technique and Bisco's unique composite chemistry. ORTHO-ONE will bond to metal or plastic brackets without additional conditioners. The product is a two part system employing a primer and an adhesive base paste. Without mixing, the primer is applied to the base paste is applied to the bracket. The orthodontist places the bracket against the tooth with a slight twisting motion causing the primer to activate the base paste, resulting in curing of the adhesive. ORTHO-ONE is a traditional dental composite formulation utilizing a silica filled dimethacrylate resin base paste and an unfilled dimethacrylate primer. The adhesive cures through a conventional amine activated benzoyl peroxide initiated free radical addition polymerization.
The provided text describes a 510(k) summary for a medical device called ORTHO-ONE, an orthodontic adhesive. The summary explicitly states that ORTHO-ONE is identical to a predicate device, RELY A.BOND, and is manufactured in the same facility using the same device master record. This implies that the acceptance criteria and proof of meeting them rely heavily on the established performance of the predicate device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ORTHO-ONE) |
|---|---|---|
| Bond Strength | Virtually eliminates bonding failures | Virtually eliminates bonding failures |
| Curing Time | Reaches maximum bond strength within 5 min | Reaches maximum bond strength within 5 min |
| Consistency/Flow | Tacky, flows easily, spreads evenly, eliminates bracket flotation | Tacky, flows easily, spreads evenly, eliminates bracket flotation |
| Flexural Modulus | Statistically indistinguishable from RELY A.BOND | 4.2 GPa (statistically indistinguishable from predicate) |
| Diametral Tensile Strength | Statistically indistinguishable from RELY A.BOND | 39 MPa (statistically indistinguishable from predicate) |
| Compressive Strength | Statistically indistinguishable from RELY A.BOND | 266 MPa (statistically indistinguishable from predicate) |
| Biocompatibility | Non-toxic | Non-toxic (negative cytotoxicity results for L-929 mouse fibroblast cells) |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The physical data and performance characteristics of ORTHO-ONE are statistically identical to RELY A.BOND as would be expected." This indicates that no separate new clinical test set was used for ORTHO-ONE for human-based performance. The primary "test set" in this context is the predicate device's established performance.
For the physical property tests (Flexural Modulus, Diametral Tensile Strength, Compressive Strength), the sample sizes are not specified, nor is the country of origin or whether the data was retrospective or prospective.
For the biocompatibility test (cytotoxicity), the sample type was L-929 mouse fibroblast cells. The sample size (number of cells or tests performed) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since the primary claim is "statistical identity" to the predicate device, there's no mention of experts establishing a "ground truth" for a new clinical test set for ORTHO-ONE. The "ground truth" for the performance claims would implicitly stem from the prior validation and clinical experience with the predicate device, RELY A.BOND. No details on this are provided in the current document.
4. Adjudication Method for the Test Set:
Not applicable, as no new clinical test set requiring expert adjudication is described for ORTHO-ONE.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is an adhesive, not an interpretative imaging or diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical adhesive material, not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for ORTHO-ONE's performance is established by its physical and chemical equivalence to the predicate device, RELY A.BOND, and the established performance history of RELY A.BOND in clinical use (implied, not detailed). The physical data provided (flexural modulus, diametral tensile strength, compressive strength) serve as objective physical measurements. Biocompatibility results are also objective lab measurements.
8. The Sample Size for the Training Set:
Not applicable. This is a manufactured product, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is a manufactured product, not an AI algorithm.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.