(90 days)
The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures
Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament Reconstruction
The EXTREMITY MEDICAL Suture Anchor
The provided text is a 510(k) summary for the EXTREMITY MEDICAL Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study for meeting specific acceptance criteria derived from device performance.
Therefore, the requested information regarding acceptance criteria, device performance testing, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving the device meets acceptance criteria cannot be found in the provided document.
This type of 510(k) submission generally relies on a comparison of design, materials, and intended use to existing legally marketed devices, rather than extensive clinical performance studies with specific statistical acceptance criteria. The "study" here is essentially the comparison to predicate devices, and the "acceptance criterion" is substantial equivalence.
Here's what can be extracted based on the nature of the document:
While the document doesn't present traditional "acceptance criteria" and a "study" to meet them in the context of device performance metrics (like sensitivity, specificity, accuracy for an AI device, or specific mechanical thresholds for a medical device), it does present the implicit acceptance criteria for its regulatory pathway: Substantial Equivalence to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit for 510(k) Pathway) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Substantial Equivalence to Predicate Devices: - Same indications for use - Similar design - Similar materials - Similar principles of operation | The EXTREMITY MEDICAL Suture Anchor is substantially equivalent to its predicate devices (TwinFix Ti 2.8 Suture Anchor K972326, TwinFix PK FP Suture Anchor K073509) based on: - Same indications for use - Similar design - Similar materials - Similar principles of operation |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This 510(k) summary does not describe a performance study with a "test set" in the traditional sense of clinical or technical data. The "test set" here is conceptually the comparison of the new device's characteristics against the predicate devices.
- Data Provenance: Not applicable. The data is descriptive of the device itself and its comparison to existing devices, not empirical performance data from patients or laboratory tests for this specific device in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment by experts for a test set is not described in this 510(k) summary, as it's not a performance study.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
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:
- Not applicable. This device is a physical suture anchor, not an AI or imaging device, and therefore an MRMC study with human readers assisting AI is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the context of a performance study. The "ground truth" for the 510(k) substantial equivalence claim is the established legal marketing status and characteristics of the predicate devices.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not a study involving machine learning or statistical modeling.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory submission for substantial equivalence of a physical medical device, not a report on a performance study with quantitative acceptance criteria and a test set.
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510(k) Summary of Safety and Effectiveness:
JAN 2 2 2009
EXTREMITY MEDICAL Implant System
| Submitter | EXTREMITY MEDICAL LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Jamy GannoePresidentPhone 973-588-8980Email jgannoe@extremitymedical.com |
| Date Prepared | December 18, 2008 |
| Trade Name | EXTREMITY MEDICAL Suture Anchor |
| Classification Nameand Number | Smooth or threaded metallic bone fixation fastener21 CFR 888 3040 |
| Product Code | MBI |
| Predicate Devices | 1 Orthopaedic Biosystems Ltd, Inc (Smith & Nephew)TwinFix Tı 2 8 Suture Anchor K9723262 Smith & Nephew TwinFix PK FP Suture AnchorK073509 |
| Device Description | The EXTREMITY MEDICAL Suture Anchor |
| Indications for use | The Extremity Medical Suture Anchor is intended for thefixation of suture and/or soft tissue to bone in the shoulder,foot/ankle, knee, hand/wrist, elbow in the following proceduresShoulder Rotator Cuff Repairs, Bankart Repair, SLAP LesionRepair, Biceps Tenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift of CapsulolabralReconstructionFoot/Ankle Lateral Stabilization, Medial Stabilization, AchillesTendon Repair, Hallux Valgus Reconstruction, Mid-foot |
| reconstruction, Metatarsal Ligament Repair/Tendon Repair,Bunionectomy | |
| Knee Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Patellar Tendon Repair, Posterior ObliqueLigament Repair, Iliotibial Band Tenodesis | |
| Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar orRadial Collateral Ligament Reconstruction | |
| Elbow Biceps Tendon Reattachment, Tennis Elbow Repair,Ulnar or Radial Collateral Ligament Reconstruction | |
| Statement ofTechnologicalComparison | The EXTREMITY MEDICAL Suture Anchor and its predicatedevices have the same indications for use have a similar designand are made of the similar materials |
| Conclusion | The EXTREMITY MEDICAL Suture Anchor is substantiallyequivalent to its predicate devices This conclusion is basedupon the fact that this device is substantially equivalent in termsof indications for use, materials, design and principles ofoperation |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Extremity Medical, LLC % Mr Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
JAN 2 2 2009
Re K083151
Trade/Device Name EXTREMITY MEDICAL Suture Anchor Regulation Number 21 CFR 888 3040 Regulation Name Smooth or threaded metallic bone fixation fastener Regulatory Class II Product Code MBI Dated October 22, 2008 Received October 24, 2008
Dear Mr Gannoe
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 adultcration
It 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 In tound 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 - Mr Jamy Gannoe
This letter will allow you to begin marketing your device as described in your Section 510(k) This lefter will allow you to begin makemily of substantial equivalence of your device to a legally
promatics notification The FDA finding of substance and thus, permits vo prematication - The PDA miding of Substantial squar device and thus, permits your device 10 proceed to the market
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please at if you desire specific advice for your device on our car as a this (CDRH's) Office of Complance at
contact the Center for Devices and Radiological Health is (CDRH) adapo by r Colliact the Content for Doviets and the regulation entitled, "Misbranding by reference to (240) 276-0120 Also, prease note the regulation regulations regarding postmarket surveillance, premarket nothcation (21CPK Pat 067 97) please contact CDRF's Office of Burvemance and the reportung of device adverse events.
Surveillance at 240-276-3474 For questions regarding the reportung of developes at 24 (Medical Device Reporting (MDR)), please contact the Division of Survelliance Systems at 240-(Medical Device Reporting (MDX)); production on your responsibilities and the Act from
276-3464 You may obtain other general information on your responsibilities and the Ac 270-5404 - You may obtain other general michiner and Consumer Assistance at its toll-free the DIVATOR OF Small Mar (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sıncerely yours,
Mark N Mulkerson
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 Suture Anchor EXTRE
510(k) Number (if known) Device Name Indications for Use•
The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures
Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament
| Reconstruction |
|---|
| ---------------- |
| Prescription Use X AND/OR Over-the-counter |
|---|
| ---------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division of General Restorative.
and Neurological Devices
| 21 510(k) Number | K083157 |
|---|---|
| ------------------ | --------- |
§ 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.