(52 days)
The INION ANCHRON™ PLUS BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows:
A. Open procedures:
- Shoulder:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site
- Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
- Biceps tenodesis
- Acromio-clavicular separation
- Elbow:
- Biceps tendon reattachment
- Ankle:
- Achilles tendon repair/reconstruction
- Lateral stabilization
- Medial stabilization at the medial talus site
- Knee:
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Joint capsule closure to anterior proximal tibia
- Posterior oblique ligament or joint capsule to tibia repair
- Extra capsular reconstruction / ITB tenodesis
- Patellar ligament and tendon avulsion repairs
B. Arthroscopic procedures:
- Shoulder:
- Bankart repair
- SLAP lesion repair
- Rotator cuff repair
- Capsule shift repair (glenoid rim)
Inion Anchron™ Plus Biodegradable Anchor System is intended to allow secure fixation of soft tissue to bone in conjunction with appropriate immobilization. The system consists of degradable suture anchor made of co-polymers PLDLA, non-degradable braided polyblend surgical suture with stainless steel needles, and a single-use suture anchor inserter. The suture anchors are dyed green. Based on in vitro testing: the suture anchors retain most of their strength up to 16 weeks and gradually loose their strength thereafter; and bioresorption takes place within three years.
Inion Anchron™ Plus Biodegradable Anchor system is provided sterile to the user. The shelf life of the device is 3 years.
This document is a 510(k) summary for the Inion Anchron™ Plus Biodegradable Anchor System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | "secure fixation of soft tissue to bone in conjunction with appropriate immobilization." |
| Material Composition | Made of co-polymers PLDLA. Same as predicate device. |
| Degradation Profile | Retains most of its strength up to 16 weeks; bioresorption within three years. Indicated as substantially equivalent to predicate. |
| Mechanical Properties | Indicated as substantially equivalent to predicate. |
| Sterility | "provided sterile to the user" |
| Shelf Life | 3 years |
Explanation of the "Acceptance Criteria": The document performs a substantial equivalence assessment. This means the "acceptance criteria" are primarily based on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data presented (degradation profile, mechanical properties) are to establish this equivalence, rather than meeting a specific numerical target for a new, novel characteristic.
2. Sample size used for the test set and the data provenance:
- The document mentions "in vitro testing" for the degradation profile. It does not provide specific sample sizes for this testing.
- The data provenance is implied to be from the manufacturer, Inion Oy, in Finland.
- The study is likely prospective in nature, as it involves testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The substantial equivalence assessment relies on internal testing and comparison to the predicate device, not on external expert consensus for a "ground truth" derived from patient data.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging, clinical outcomes reviewed by multiple experts), which is not the primary focus of this 510(k) submission for a medical device.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biodegradable anchor system, not an AI-assisted diagnostic or monitoring tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "degradation profile" and "mechanical properties," the "ground truth" would be established by direct measurement in laboratory settings according to established scientific and engineering principles (e.g., measuring strength over time, analyzing material composition).
- For the overall "equivalence" claim, the ground truth is the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- This question is not applicable as the device is not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- This question is not applicable as the device is not an AI model requiring a training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.