(55 days)
Shoulder - bankart repair
Hand/wrist - ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment
Skull - lateral canthoplasty
Foot/ankle - hallux valgus reconstruction, midfoot reconstructions
Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
The provided document is a 510(k) summary for the Li Medical LM Anchor, a bone fixation device. It describes the device, its intended use, and its comparison to a predicate device, along with performance data. However, it is not a study that contains detailed acceptance criteria or extensive performance data suitable for a detailed table as requested in the prompt.
Here's an analysis based on the available information, with significant limitations due to the nature of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a formal table. Instead, it makes a qualitative comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to or exceeding the mean pullout strength of the Mitek anchor (predicate device). | "The mean pullout strength of the LM Anchor was substantially equivalent to or exceeded the mean pullout strength of the Mitek anchor." |
Limitations: The document does not provide specific numerical values for pullout strength for either the LM Anchor or the Mitek anchor, nor does it define the threshold for "substantially equivalent" in terms of a specific percentage or statistical margin.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "cadaver specimen" but does not quantify the number of specimens or anchors tested.
- Data Provenance: "Pre-clinical testing in cadaver specimen." This implies the data is retrospective as the tests were completed before the 510(k) submission. The country of origin is not specified, but the applicant is a US company (Shelton, CT).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This type of study (mechanical pullout strength in cadaver specimens) does not typically involve human experts establishing a "ground truth" in the way clinical studies with diagnostic devices might. The "ground truth" is the measured mechanical property (pullout strength).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 for consensus) are relevant for studies involving human interpretation or subjective assessments, which is not the case for a mechanical pullout strength test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where multiple readers interpret clinical cases, often to assess the impact of AI assistance. The LM Anchor is a medical device for bone fixation, and its performance is evaluated through mechanical testing, not diagnostic interpretation.
6. Standalone (Algorithm Only) Performance
Not applicable. The LM Anchor is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this study was mechanical measurements of pullout strength. This is an objective, quantitative physical property.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning algorithm, so there is no "training set" in the computational sense. The "training" for the device would be its design and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set as it pertains to AI/ML.
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JUL 1 3 1998
510(K) SUMMARY
:
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,203-944-2800 |
|---|---|
| Contact: | Rhodemann Li, Vice President |
| Date: | May 18, 1998 |
| Classification Name: | Staple, Fixation, Bone |
| Common Name: | Bone anchor |
| Proprietary Name: | LM Anchor or other proprietary name |
| Predicate Device: | Mitek Surgical Products Mini Anchor (K930892) |
| Device Description: | Made from surgical grade stainless steel (316L), theLM Anchor is designed with a crown and a center pinthrough which suture is passed to provide a means forsoft tissue to bone attachment. |
| Intended Use: | Shoulder (bankart repair), Hand/Wrist (ulnar or lateralcollateral ligament reconstruction, scapholunate ligamentreconstruction, PIP collateral ligament, profundus tendonreattachment), Skull (lateral canthoplasty), Foot/Ankle(hallux valgus reconstruction, midfoot reconstructions. |
| Technical Comparison: | The LM Anchor is similar to the Mitek anchors in itscylindrical shape, however, the bony purchase isaccomplished by the LM Anchor through cantileveredbeams versus nitinol arcs with the Mitek anchors. |
| Performance Data: | Pre-clinical testing in cadaver specimen showed thatthe mean pullout strength of the LM Anchor wassubstantially equivalent to or exceeded the mean pulloutstrength of the Mitek anchor. |
:
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
Mr. Rhodemann Li ·Vice President Li Medical Technologies, Inc. 4 Armstrong Road 06484 Shelton, Connecticut
Re: K981764 Trade Name: LM Anchor Requlatory Class: II Product Codes: MBI, HWC, and GAT Dated: May 18, 1998 Received: May 19, 1998
Dear Mr. Li:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Rhodemann Li
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
Ph.D., M.D. M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K981764
LM Bone Anchor Device Name:
Indications For Use:
Shoulder - bankart repair
Hand/wrist - ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment
Skull - lateral canthoplasty
Foot/ankle - hallux valgus reconstruction, midfoot reconstructions
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pcoolo
(Divest Sign Off)
D general
510(k) number K9821764
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
: |
(Optional Format 1-2-96)
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§ 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.