(64 days)
UltraFix RC: Shoulder (rotator cuff repair)
UltraFix Mini: Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament)
UltraFix: Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are 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 text describes a 510(k) summary for the LM Anchor Products, focusing on their substantial equivalence to predicate devices, specifically Mitek Surgical Products GII QuickAnchor. However, the document does not contain the information needed to answer your specific questions about acceptance criteria and a study proving a device meets them.
The 510(k) summary mentions "Performance Data" with "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor Products were substantially equivalent to the mean pullout strength of the Mitek anchors." This statement is the closest to addressing performance, but it lacks the detailed information you requested.
Here's why I cannot provide the requested information based on the input:
- Acceptance Criteria: The document does not explicitly state any numerical or qualitative acceptance criteria for the LM Anchor Products' performance. It only states that their pullout strength was "substantially equivalent" to the predicate device.
- Reported Device Performance: While it mentions "mean pullout strength," it doesn't provide the actual numerical values for either the LM Anchor Products or the Mitek anchors.
- Sample Size (Test Set) and Data Provenance: The document states "cadaver specimen" but does not specify the number of specimens (sample size) or any details about their origin (e.g., country of origin). It is implicitly retrospective as it's pre-clinical testing.
- Number of Experts and Qualifications: This information is entirely absent. There's no mention of experts establishing ground truth for the pullout strength measurements.
- Adjudication Method: Not applicable or mentioned as there's no expert-based evaluation or scoring.
- MRMC Comparative Effectiveness Study: There is no indication of an MRMC study. This type of study is typically for evaluating a diagnostic AI device's impact on human readers, which is not relevant to a bone anchor's pullout strength.
- Standalone Performance: The pre-clinical testing mentioned is a standalone performance evaluation of the device itself (its mechanical properties), but the details are missing.
- Type of Ground Truth: For the pullout strength, the "ground truth" would be the measured physical force. However, this is not explicitly stated in the provided text.
- Sample Size for Training Set: There's no mention of a "training set" as this is not an AI/machine learning device.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided 510(k) summary is very high-level and only states that pre-clinical cadaver testing showed substantial equivalence in pullout strength to a predicate device. It does not provide the detailed scientific study design or results that your questions require.
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NOV 1 2 1996
510(K) SUMMARY
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,203-944-2800 |
|---|---|
| Contact:Date: | Rhodemann Li, Vice PresidentOctober 30, 1996 |
| Classification Name:Common Name:Proprietary Name: | Staple, Fixation, BoneBone anchorLM Anchor Products or other proprietary names |
| Predicate Devices: | Mitek Surgical Products GII QuickAnchor (K904436)Li Medical Bone Anchor (K951233), (K951472),(K953764), (K960448), (K960439), (K960825) |
| Device Description: | Made from surgical grade stainless steel (316L) or titanium(6A1-4V ELI), the LM Anchor Products are designed witha crown and a center pin through which suture is passed toprovide a means for soft tissue to bone attachment. |
| Intended Use: | |
| UltraFix RC | Shoulder (rotator cuff repair) |
| UltraFix Mini | Hand/Wrist (ulnar or lateral collateral ligamentreconstruction, radial collateral ligament, scapholunateligament reconstruction), Foot/Ankle (hallux valgusreconstruction, midfoot reconstructions, lateralstabilization, medial stabilization, achilles tendon),Elbow (biceps tendon, ulnar collateral ligament, radialcollateral ligament) |
| UltraFix | Shoulder (bankart repair, rotator cuff repair, SLAPlesion, acromio-clavicular separation, biceps tenodesis,deltoid repair, capsular shift reconstruction,capsulolabral reconstruction), Hand/Wrist (ulnar orlateral collateral ligament reconstruction, radialcollateral ligament, scapholunate ligamentreconstruction), Foot/Ankle (hallux valgusreconstruction, midfoot reconstructions, lateralstabilization, medial stabilization, achilles tendon),Elbow (biceps tendon, ulnar collateral ligament, radialcollateral ligament), Knee (medial collateral ligament,lateral collateral ligament, patellar tendon, patellar ligamentavulsions, posterior oblique ligament, joint capsule to tibia,iliotibial band tenodesis). |
| Technical Comparison: The LM Anchor Products are similar to the Mitek anchorsin its cylindrical shape, however, the bony purchase is |
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accomplished by the LM Anchor Products through cantilevered beams versus nitinol arcs with the Mitek anchors.
Performance Data:
Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor Products were substantially equivalent to the mean pullout strength of the Mitek anchors.
§ 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.