(90 days)
The Modified Mitek 3.5mm Absorbable Suture Anchor System is intended for use in soft tissue to bone fixation in association with adequate post-operative immobilization.
The Mitek PANALOK 3.5mm Absorbable Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4. a. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation ELBOW: 1. Biceps tendon/reattachment ANKLE: 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site KNEE: 1. Medial collateral ligament repair 2. Lateral collateral ligament repair 3. Join capsule closure to anterior proximal tibia 4. Posterior oblique ligament or joint capsule to tibia repair 5. Extra capsular reconstruction/ITB tenodesis 6. Patellar ligament and tendon avulsion repairs ARTHROSCOPIC PROCEDURES SHOULDER: - Bankart repair 1. - 2. SLAP lesion repair - 3. Rotator cuff repair - Capsule shift repair (glenoid rim) 4.
The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System is designed to implant within a pre-drilled bone hole site and provide a means for firmly securing soft tissue to bone using sutures. The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System includes a PLL (homopolymer poly (L(-)-lactide) anchor pre-threaded with ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed, two pre-attached surgical needles, and a pre-assembled disposable inserter. The system is supplied sterile and ready for use. Mitek instruments, drill and drill guide, are to be used to install the Mitek PANALOK 3.5mm Absorbable Suture Anchor. The drill bit creates a hole 3.5mm in diameter by 18mm deep. Poly (L(-)-lactide) polymer is nonpyrogenic.
This submission describes a medical device, the Modified Mitek 3.5mm Absorbable Suture Anchor System, and its substantial equivalence to a predicate device, the Mitek 3.5mm Absorbable Suture Anchor System.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a table of acceptance criteria or specific quantitative performance metrics for the modified device. It makes a general statement about substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Nonclinical laboratory testing was performed to assess the in vitro and in vivo strength and failure modes." However, it does not specify the sample size for this testing, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not mentioned in the provided document. The study described is non-clinical laboratory testing, not a study involving human expert assessment of a test set in the context of AI or diagnostic imaging.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is non-clinical laboratory testing and does not involve human readers or adjudication processes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. The device is a surgical anchor, not an AI or diagnostic imaging system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the device described. The "device" is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical laboratory testing would be the measured physical properties and performance characteristics of the Suture Anchor System (e.g., strength, failure modes) under specific experimental conditions. It's based on engineering and biomechanical principles, not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic or AI studies.
8. Sample Size for the Training Set
There is no mention of a training set in this document. The device is a physical product, not an AI model that requires training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned, this information is not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on Provided Text):
The provided text states:
- "Nonclinical laboratory testing was performed to assess the in vitro and in vivo strength and failure modes."
- "The modified device has the same technological characteristics as the predicate device. There are no changes in chemistry, material or composition. When compared to the predicate device, it only differs in that the ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed is being attached to its anchor system."
- "Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the predicate device under the Federal Food, Drug. and Cosmetic Act."
Interpretation:
The "acceptance criteria" appear to be broadly defined by the performance of the legally marketed predicate device. The study performed was non-clinical laboratory testing to evaluate the in vitro and in vivo strength and failure modes of the modified device. The conclusion of substantial equivalence is based on:
- The modified device having the same technological characteristics (chemistry, material, composition) as the predicate.
- The only difference being the specific suture being attached.
- The results of the non-clinical laboratory testing demonstrating comparable strength and failure modes.
Therefore, the study proves substantial equivalence by showing that despite a minor modification (the specific suture), the core performance characteristics (strength, failure modes) are maintained through laboratory testing, aligning with the predicate device's established safety and effectiveness. The specific quantitative results of this testing, which would form the basis of the "reported device performance" against implied acceptance criteria, are not detailed in this summary.
§ 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.