(83 days)
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.
The device consists of two units, the force sensing unit and an electronic display. The eLIBRATM Force Sensing Tibial Unit is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The electronic signal represents the relative medial and lateral compartment forces generated from the soft tissue structures surrounding the knee joint during a total knee arthroplasty (TKA). The LIBRA Dynamic Knee Balancer eLIBRATM Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRATM Force Sensing Tibial Unit. The unit displays a number from 0-19 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
The provided text describes the eLibra Dynamic Knee Balancer, an orthopedic manual surgical instrument used in total knee arthroplasty (TKA). It outlines the device's description, intended use, and technological characteristics. However, it does not contain specific acceptance criteria, detailed performance metrics, or a comprehensive study plan with the information requested.
Here's an analysis of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The submission mentions "results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices," but this is a general statement, not quantified acceptance criteria.
- Reported Device Performance:
- Bench Testing: Included "mechanical testing, radio frequency, and sterility testing, including EO residues." The results were deemed "satisfactory."
- Clinical Testing: Performed to determine "adequacy of instructions for use, the range of patient population, performance characteristics, and reliability." The results were "satisfactory."
- Conclusion: "The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance | Comments |
|---|---|---|
| (e.g., Accuracy of force readings: X% within predicate) | "Satisfactory" for mechanical, radio frequency, sterility tests | No specific quantitative performance metrics are provided for the force sensing or display. |
| (e.g., Clinical reliability: Y% of cases without issue) | "Satisfactory" for clinical testing regarding instructions for use, patient population range, performance characteristics, and reliability | No specific quantitative performance metrics are provided from clinical testing. |
| (e.g., Equivalent safety profile to predicate) | "As safe... as compared to predicate devices" | No specific adverse event rates or safety comparisons are provided. |
| (e.g., Equivalent effectiveness to predicate) | "As effective... as compared to predicate devices" | No specific clinical outcome measures or effectiveness comparisons are provided. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The text only mentions "clinical tests were performed" without detailing the number of patients or cases.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only states "clinical testing was performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It only mentions aiding "the surgeon in balancing soft tissue structures."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- MRMC Study: Not applicable. The device is a force-sensing instrument for surgical assistance, not an imaging or diagnostic AI tool that would involve human readers.
- Effect Size: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense for an AI algorithm. The device itself (eLibra Dynamic Knee Balancer) provides a direct reading (numbers 0-19) for the surgeon to interpret and act upon. It's an instrument providing information to a human operator, not a standalone diagnostic or assistive AI system. Its "standalone" performance would be its accuracy and reliability in measuring force and displaying it. However, no specific details on this are provided beyond "satisfactory."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: Not explicitly stated or defined. For a force-sensing device, the "ground truth" would likely involve comparison to established methods or calibrated force measurement systems in bench testing, and potentially clinical outcomes or successful soft tissue balancing assessed intra-operatively by surgeons in clinical testing. However, the document does not specify how this "ground truth" was established or measured for the clinical tests.
8. The sample size for the training set
- Not applicable. The device is a hardware instrument with a display, not a machine learning model that undergoes a "training set" in the context of AI.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
Summary of Missing Information:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, as well as general safety and effectiveness through satisfactory bench and clinical testing. It lacks detailed quantitative performance data, specific acceptance criteria, sample sizes for testing, and methodologies for ground truth establishment or expert involvement, which are typically found in more comprehensive study reports for AI/diagnostic devices. This is common for predicate-based medical devices that are not complex AI systems.
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APR 4 - 2007
K 070108
510(K) Summary Synvasive Technology, Inc. 4925 Robert J. Mathews Pkwy El Dorado Hills, CA 95762 Phone: 916-939-3913 Contact: Michael G. Fisher Date prepared: December 20, 2006
- Trade Name: eLibra Dynamic Knee Balancer 1. Common Name: Orthopedic manual surgical instrument Classification Name: Orthopedic manual surgical instrument, product code LXH, Regulation: 888.4540 Class of device: Class I.
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : The 2. Libra Dynamic Knee Balancer (510(k) exempt) manual orthopedic surgical instrument set.
- Description of device: The device consists of two units, the force sensing unit and an 3. electronic display. The eLIBRATM Force Sensing Tibial Unit is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The electronic signal represents the relative medial and lateral compartment forces generated from the soft tissue structures surrounding the knee joint during a total knee arthroplasty (TKA). The LIBRA Dynamic Knee Balancer eLIBRATM Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRATM Force Sensing Tibial Unit. The unit displays a number from 0-19 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
- Intended use: For use as a tool for adjustment of the femoral knee implant to reduce 4. instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.
- Technological characteristics: The subject device differs from the predicate manual ડ. orthopedic device in that it employs a WIRELESS connection to the digital display unit.
- Performance: Both bench and clinical tests were performed. Bench testing included 6. mechanical testing, radio frequency, and sterility testing. including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synvasive Technologies. Incorporated % Michael G. Fisher President and Chief Executive Officer 4925 Robert J. Mathews Pkwy. El Dorado Hills, California 95762
JUL 2 2009
Synvasive Technologies, Incorporated
% Michael G. Fisher
President and Chief Executive Officer
4925 Robert J. Mathews Pkwy.
El Dorado Hills, California 95762
Re: K070108
Trade/Device Name: eLibra Dynamic Knee Balancer Regulation Number: 882.4560 Regulation Name: Sterotaxic instrument Regulatory Class: II Product Code: ONN Dated (Date on orig SE itr): April 4, 2007 Received (Date on orig SE ltr): April 4, 2007
Dear Mr. Fisher:
This letter corrects our substantially equivalent letter of April 4, 2007.
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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21
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Page 2-Mr. Michael G. Fisher
CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Karbenbuchus
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.
Prescription Use _ X AND/OR (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Berbare Buchmo
(Division Sign-Off)
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510(k) Number K070108
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).