(100 days)
The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.
The Alpha-Bio Bone Fixation Screw System consists of titanium alloy Gr-5 screws with 1.2mmd and 1.6mmd diameter, and with 4mm-12mm lengths. This system includes drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure
The provided document is a 510(k) premarket notification for a medical device, the Alpha-Bio Tec® Bone Fixation Screw System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is largely not applicable to this type of submission.
Here's an explanation based on the provided text:
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Table of acceptance criteria and reported device performance: Not applicable. For a 510(k) submission, especially for a device like a bone fixation screw system, "acceptance criteria" are generally related to demonstrating substantial equivalence in terms of materials, intended use, and mechanical performance, rather than clinical performance metrics. The document states "No performance standards have been established for such devices under Section 514 of the Federal Food, Drug, and Cosmetic Act." and instead refers to compliance with recognized standards for biocompatibility, materials, and resistance (see point 1 below for details).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This submission does not describe a clinical study with a "test set" in the context of AI/diagnostic device evaluation. The "performance and safety testing" mentioned (Section J) refers to bench testing to demonstrate physical properties and biocompatibility, not clinical outcomes from patient data.
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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 clinical "ground truth" or expert review of clinical data is described in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical "test set" requiring adjudication is described.
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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 bone fixation screw system, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical surgical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a device like this relates to its physical and biological properties.
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The sample size for the training set: Not applicable. There is no AI component or "training set" for this device.
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How the ground truth for the training set was established: Not applicable.
However, the document does contain information relevant to the device's "acceptance" based on recognized standards and equivalence to a predicate device:
Here's a breakdown of the relevant information from the provided text, re-framed to address the spirit of the request where possible:
1. Table of "Acceptance Criteria" (Standards Compliance) and Reported Device Performance (as implied by equivalence):
| "Acceptance Criteria" (Standards Complied With) | Reported Device Performance (Implied by Equivalence and Testing) |
|---|---|
| ISO 7405:1997: Dentistry Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental | Biocompatibility: The device is considered biocompatible, as demonstrated by compliance with ISO 7405:1997. Specific test results are not detailed in this summary but are implied to be satisfactory. |
| ASTM F136-02a: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) | Material Composition (Screws): The titanium alloy screws conform to this standard for surgical implant applications, ensuring appropriate material properties for strength, corrosion resistance, and biocompatibility. |
| ASTM F1350-02: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) | Material Composition (Implied for other components/instruments or previous versions): Although the screws are Titanium Gr-5, compliance with this standard suggests other components (or potentially the drill instrument, or for general material quality understanding for the submission) meet standards for surgical stainless steel, ensuring appropriate material properties. (Note: The document explicitly states screws are Titanium Gr-5, so this standard might apply to other system components, though not explicitly stated for the screws themselves). |
| ISO 13402:1995: Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure | Instrument Durability and Sterilization Resistance: The surgical and dental hand instruments (e.g., drill instrument) in the system meet standards for resistance to autoclaving, corrosion, and thermal exposure, ensuring their reusability and integrity during sterilization processes. |
| UL 544 (1998): Standard for Medical and Dental Equipment - Ed. 4.0 | Electrical Safety (if applicable): While a bone screw system often doesn't have electrical components, if the drill instrument or associated equipment is electrical, compliance with UL 544 ensures electrical safety standards are met. |
| Substantial Equivalence to Predicate Devices (Straumann K050515; K011698) | Overall Safety and Effectiveness: The device is demonstrated to be substantially equivalent to previously cleared predicate devices in terms of intended use, indications for use, technological characteristics, performance, and user interface. This implies a comparable safety and effectiveness profile to already-marketed devices. Specific "safety and performance testing" (Section J) was conducted, presumably bench tests to confirm physical and mechanical equivalency. |
Summary of the Study (or Basis for Acceptance):
The "study" presented here is a 510(k) Premarket Notification designed to demonstrate substantial equivalence to legally marketed predicate devices, not to prove meeting specific clinical performance acceptance criteria in the manner of an AI diagnostic device.
- Basis for Acceptance: The device is accepted because it has been shown to be substantially equivalent to predicate devices (Straumann K050515; K011698) in terms of intended use, indications for use, technological characteristics (Titanium alloy Gr-5, specific diameters and lengths), and performance. This equivalence is supported by compliance with recognized international and ASTM standards for biocompatibility, material composition, and instrument durability, as well as general "safety and performance testing" (likely bench testing) that confirmed comparable physical and mechanical properties.
- Key points from the submission:
- Device Description: Consists of titanium alloy Gr-5 screws (1.2mmd and 1.6mmd diameter, 4mm-12mm lengths) and a drill instrument for fixation in oral cavity bone regeneration procedures.
- Intended Use/Indications for Use: Stabilize and fixate bone grafts, bone filling materials, and/or barrier membranes for bone regeneration in the oral cavity.
- Predicate Devices: Straumann K050515; K011698.
- Equivalence Justification: No unique applications, indications, materials, or specifications compared to the predicate. Intended use and indications were previously cleared for the predicate. Technical characteristics are similar. Safety and performance testing (bench-level) was conducted.
- Conclusion: The Alpha-Bio Tec® is substantially equivalent to its predicate devices and "raises no new safety and/or effectiveness issues."
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K06 3769
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| Alpha Bio | MAR 3 0 2007 | |||
|---|---|---|---|---|
| Alpha-Bio Tec03/06 | RA Department | FDA Traditional 510k | Page 28 of 32 | |
| 510(K) SUMMARY | ||||
| Alpha-Bio Tec® Bone Fixation Screw System | ||||
| 510(k) Number K | ||||
| A. Applicant's Name: | Alpha-Bio Tec Ltd | |||
| 7, Embar st. | ||||
| Industrial Zone Kiryat Arie | ||||
| POB 3936 ZIP 49130 | ||||
| Petach-Tikva, Israel | ||||
| Tel: +972-3-9291000 / 9390668 | ||||
| Fax: +972-3-9235055 | ||||
| e-mail: ophir@alpha-bio.net; Daniela@alpha-bio.net | ||||
| Web site: www.alpha-bio.net | ||||
| B. Contact Person: | Daniela Ben Shabat | |||
| Alpha-Bio Tec Ltd | ||||
| 7, Embar st. | ||||
| Industrial Zone Kiryat Arie | ||||
| POB 3936 ZIP 49130 | ||||
| Petach-Tikva, Israel | ||||
| Tel: +972-3-9291000 / 9390668 | ||||
| Fax: +972-3-9235055 | ||||
| e-mail: Daniela@alpha-bio.net | ||||
| Web site: www.alpha-bio.net | ||||
| C. Date Prepared: | March 2006 | |||
| D. Trade Name: | Alpha-Bio Tec® | |||
| E. Classification: | Name: | Screw, Fixation, Intraosseous | ||
| Product Code: | DZL | |||
| Regulation No: | 872.4880 | |||
| Class: | II | |||
| Panel: | Dental | |||
| F. Predicate Devices: | The Alpha-Bio Bone Fixation Screw System is substantially equivalent to Straumann K050515; K011698; in terms of intended use, indications for use, technological characteristics, performance and user interface. | |||
| The predicate device is Class II medical devices. | ||||
| A discussion of substantial equivalence is provided in Section 3 of this submission. |
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Alpha Bio
| Alpha-Bio Tec 03/06 | RA Department | FDA Traditional 510k | Page 29 of 32 |
|---|---|---|---|
| --------------------- | --------------- | ---------------------- | --------------- |
בס"ד
- G. Device Description: The Alpha-Bio Bone Fixation Screw System consists of titanium alloy Gr-5 screws with 1.2mmd and 1.6mmd diameter, and with 4mm-12mm lengths. This system includes drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure
- H. Intended Use / Indication for Use: The Alpha-Bio Bone Fixation Screw System is indicated for stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.
- Performance Standards: No performance standards have been established for I. such devices under Section 514 of the Federal Food, Drug, and Cosmetic Act.
The device complies with the following recognized standards:
- ISO 7405:1997, Dentistry Preclinical Evaluation of . Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental
- F136-02a: 2004 Standard Specification for Wrought . Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
- ASTM F1350-02, 2002 Standard Specification for . Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673).
- . ISO 13402:1995. Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
- UL 544 (1998):, Standard for Medical and Dental . Equipment - Ed. 4.0.
- J. Substantial Equivalence: There are no unique applications, indications, materials or specifications presented below. Evidence of equivalence has been demonstrated through:
- . The Alpha-Bio Tect intended use and indications for use were previously cleared by FDA for the predicate device.
- · The technical characteristics of the Alpha-Bio Tec® are similar to those of the predicate device.
- · Safety and performance testing.
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| Alpha-Bio Tec 03/06 | RA Department | FDA Traditional 510k | Page 30 of 32 | רס"ד |
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Therefore, the Alpha-Bio Tec® is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alpha-Bio Tec Limited C/O Mr. Daniel J. Manelli Attorney Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue, NW Suite 440 Washington, DC 20015
MAR 3 0 2007
Re: K063769 Trade/Device Name: Alpha Bio Tec® Bone Fixation Screw System Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: December 19, 2006 Received: December 20, 2006
Dear Mr. Manelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Manelli
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sydtte y. Michael md.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Alpha-Bio Tec03/06 | RA Department |
|---|---|
| FDA Traditional 510k | Page 32 of 32 |
INDICATIONS FOR USE
510(k) Number (if known): KO (03769
Device Name: Alpha Bio Tec® Bone Fixation Screw System
Indications for Use:
The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.
Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
. . . ം വ് Anestheshology
Dentrol, Dental Devices ു (k) Number:
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.