(176 days)
The Unity Alpha PLLA System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
The Unity Alpha PLLA System is designed for the fixation of tissue, ligament, tendon. and bone. Absorbable poly-1.-lactic acid (PLLA) implant materials are ultrasonically welded to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon. and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management.
The provided text describes the Unity Alpha PLLA System (medical device) and its 510(k) submission. It does not include detailed information regarding acceptance criteria, specific performance metrics, sample sizes for testing/training sets, expert qualifications, or adjudication methods for a study. The document primarily focuses on establishing substantial equivalence to a predicate device.
However, based on the text, here's what can be extracted and what cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The general acceptance criterion implied is "substantial equivalence" to predicate devices. | "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Alpha PLLA System to predicate devices." No specific quantitative performance metrics are provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal design verification.
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/Not specified. The "ground truth" for this device appears to be comparison against predicate devices' mechanical properties, not expert-adjudicated clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- No. This is a medical device for fixation of tissue, ligament, tendon, and bone, not an AI or imaging diagnostic device requiring an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is not an algorithm. Performance is likely assessed through mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference standard for comparison was the mechanical strengths and failure modes of predicate devices. This suggests a comparative engineering/mechanical testing approach.
8. The sample size for the training set
- Not applicable/Not specified. There is no mention of a "training set" in the context of this device's approval process, as it is not an AI or machine learning product.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
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Koba820 page 14
MAR 1 5 2007
fingham, IL 62401
Phone: 217 342 34 217,342,3460 http://www.bonuttitec.com
Bonutti Research, Inc. Unity Alpha PLLA System 510(k) Premarket Motification
510(k) SUMMARY
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Patrick Balsmann, MBA, MS, RAC Contact Person: Director, Regulatory/Clinical Affairs & QA Bonutti Research, Inc., P.O. Box 1367 Effingham, Illinois 62401 Phone: (217) 342-3412, ext. 321 Fax: (217) 342-1043
Date Prepared: March 13, 2007
Proprietary Name: Unity Alpha PLLA System
Common Name: Fixation Device
Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
Device Description: The Unity Alpha PLLA System is designed for the fixation of tissue, ligament, tendon. and bone. Absorbable poly-1.-lactic acid (PLLA) implant materials are ultrasonically welded to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon. and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management.
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Bonutti Research, Inc. - Unity Alpha PLLA System 510(k) Summary -- March 13, 2007 Page 2
Indications for Use: The Unity Alpha PLLA System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the lixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
Predicate Device(s): The Unity Alpha PLLA System is similar in design and intended use to existing Bonutti Research, Inc., fixation products and various other suture anchors determined to be substantially equivalent and that are commonly used in tissue and bone fixation.
Predicate Comparison: Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Alpha PLLA System to predicate devices.
Submitted by:
A. A. Peterson?
Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bonutti Research, Inc. % Patrick G. Balsmann, M.B.A., M.S., R.A.C. Director, Regulatory/Clinical Affairs and Quality Assurance P.O. Box 1367 Effingham, Illinois 62401
MAR 1 5 2007
Re: K062820 Trade/Device Name: Unity Alpha PLLA System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II
Product Code: HWC Dated: March 8, 2007 Received: March 9, 2007
Dear Mr. Balsmann:
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.
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.
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Page 2 - Patrick G. Balsmann, M.B.A., M.S., R.A.C.
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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Bochum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K062820
Device Name: Unity Alpha PLLA System
Indications For Use: The Unity Alpha PLLA System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
Prescription Use_ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Oarbaea bucuup
(Division Sign-Off) Division of General, Bostorative, and Neurological Devaces
510(k) Number K0612820
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.