(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.
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K9629
510(k) SUMMARY
As Required By the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
PREDICATE DEVICE
RELY . A . BOND™
RELY • A•BOND is claimed to have solved one of the major complaints with one-step orthodontic adhesive systems, namely bond strength. It is formulated with a highly filled paste that combines with a unique primer to produce a bond strength to etched enamel that virtually eliminates bonding failures. The catalyst insures that the material reaches maximum bond strength within five minutes. The paste is comprised of a high percentage of small particles that result in a tacky consistency. Bracket flotation is said to be totally eliminated with Rely A.BOND. The paste flows easily onto the bracket pad and spreads evenly under the pad upon placement.
DESCRIPTION OF APPLICANT PRODUCT
ORTHO-ONE™
ORTHO-ONE is identical to the Predicate Device (Rely A.Bond). Bisco, Inc. manufacturers both products in the sam facility using the same Device Master Record. The comments noted above for the IDENTIFICATION OF THE PREDICATE DEVICE pertain to the applicant product. That is, the applicant product has solved one of the major complaints with one-step orthodontic adhesive systems, namely bond strength. It is formulated with a highly filled paste that combines with a unique primer to produce a bond strength to etched enamel that virtually eliminates bonding failures. The catalyst insures that the material reaches maximum bond strength within five minutes. The paste is comprised of a high percentage of small particles that result in a tacky consistency. Bracket flotation is said to be totally eliminated with Relv.A. The paste flows easily onto the bracket pad and spreads evenly under the pad upon placement.
INTENDED USES OF APPLICANT DEVICE
ORTHO-ONE is indicated for the adhesion of orthodontic brackets to acid etched enamel.
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS
ORTHO-ONE and RELY . A.BOND (K875143) are identical products manufactured in the same facility using the same Device Master Record. 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.
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BISCO, INC., 1500 W. Thorndate Ave., Itasca, IL 60143 510(k) submission for ORTHO-ONE
510(k) SUMMARY (continued) As Required By the Safe Medical Devices Act of 1990
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS (continued)
ORTHO-ONE, unlike conventional dental adhesives, does not require mixing in the traditional sense. That is, one is not required to mix a base and a catalyst on a mixing pad and deliver the mixed material to the mouth. 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 physical data and performance characteristics of ORTHO-ONE are statistically identical to RELY . A BOND as would be expected. The flexural modulus (4.2 GPa), diametral tensile strength (39 MPa), and compressive strength (266 MPa) are statistically indistinguishable for the predicate and applicant product.
BIOCOMPATIBILITY of APPLICANT DEVICE
Agarose diffusion method for cytotoxicity using L-929 mouse fibroblast cells was used to assess cytotoxicity: results were negative relative to a negative and a positive control. That is, ORTHO ONE was found to be non-toxic for L-929 mouse fibroblast cells under the described test parameters.
Jamu L. Sandise
James L. Sandrik, Ph.D Bisco, Inc. Itasca, IL 60143
July 25, 1996
§ 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.