(56 days)
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), 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.
Let's break down the information provided about the K981755 device, "LM Anchor," in relation to your request.
Acceptance Criteria and Device Performance for LM Anchor (K981755)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Mitek Surgical Products GII Anchor, K915889) in terms of pullout strength. | The mean pullout strength of the LM Anchor was substantially equivalent to or exceeded the mean pullout strength of the Mitek anchor. |
Explanation: The K981755 submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. In this context, the "acceptance criteria" are implicitly tied to demonstrating that the new device performs at least as well as, or equivalently to, the predicate device in relevant performance characteristics. For a bone anchor, pullout strength is a critical mechanical property.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Pre-clinical testing in cadaver specimen," implying a certain number of cadaver specimens were used, but the exact count of anchors tested or specimens involved is not provided.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but "Pre-clinical testing" generally implies a prospective study design conducted for the purpose of the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This device is a bone anchor, and the performance assessment (pullout strength) is a physical, objective measurement, not typically subject to interpretation by human experts to establish "ground truth" in the way a diagnostic imaging device would be.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since the "ground truth" is a direct physical measurement (pullout strength), there's no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret medical images. The LM Anchor is a medical implant, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? This question is generally relevant for AI/ML algorithms. The LM Anchor is a mechanical device, so the concept of an "algorithm only" performance study does not apply. The performance data presented (pullout strength) is the standalone performance of the device.
7. Type of Ground Truth Used
- Type of Ground Truth: Objective physical measurement: Pullout Strength. This is a direct, quantifiable mechanical property of the device when implanted in bone.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The LM Anchor is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The engineering design and manufacturing processes are based on established biomechanical principles and material science, not machine learning.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no "training set." The performance characteristics of the device are validated through pre-clinical testing, comparing its physical properties to those of an established predicate device.
§ 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.