(57 days)
The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Bankart lesion repairs - S.L.A.P. lesion repairs - Acromio-clavicular Repairs - Capsular Shift/Capsulolabral Reconstruction - Deltoid Repair - Rotator cuff tear repairs - Biceps tenodesis; Foot and Ankle - Medial/lateral repairs, reconstructions 1 - Achilles tendon repairs - Midfoot and forefoot repairs - Hallux Valgus reconstruction; Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment; Knee - Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repair - -VMO advancement - Joint capsule closure; Hand/Wrist - Collateral ligament repair (Gamekeeper's Thumb) - -Scapholunate ligament reconstruction - Tendon transfers in phalanx - Volar plate reconstruction
The anchor is cylindrical in shape and is preassembled threaded with USP size 2-0 I he anchor is cynnurear in shape and if production Device holds the anchor and through 2 braided poryester suture. The mass of the sutures can then be used to secure the soft tissue to the bone.
The provided document describes a 510(k) premarket notification for a medical device called the "Multitak Suture System." This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to establish acceptance criteria and performance against those criteria.
Therefore, much of the requested information, specifically regarding detailed acceptance criteria, study methodologies (test set, ground truth, expert involvement, MRMC studies, standalone performance, training set details), and specific performance metrics in numerical terms, is not available in the provided text.
The document primarily focuses on:
- Identifying the device and its intended use.
- Listing predicate devices.
- Stating that performance data was collected (pullout testing).
- Concluding that the device is substantially equivalent to predicate devices based on this testing.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in numerical terms within the document. | "The Multitak Suture System was compared in pullout testing to the predicate device... the Multitak Suture System demonstrated pullout strength equal to or better than the predicate device(s)." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "pullout testing," which implies laboratory or bench testing rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as this was likely bench testing, not an expert-driven ground truth assessment.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable, as this was likely bench testing.
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
- MRMC Study: No. This device is a surgical anchor, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the "pullout testing," the ground truth would inherently be against a quantitative measurement of the mechanical property (pullout strength) of the device itself and its predicate. It's not a clinical "ground truth" derived from patient outcomes or pathology.
8. The sample size for the training set
- Sample Size: Not applicable. This device is a physical medical device, not an AI model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
Summary of the "Study" (Per the Document):
The document states that the Multitak Suture System underwent pullout testing. The "proof" that it meets acceptance criteria (which are implied to be "equal to or better than the predicate device's pullout strength") is the conclusion that the device "demonstrated pullout strength equal to or better than the predicate device(s)." This is a comparative biomechanical study, not a clinical trial with human subjects. The full details of this testing (e.g., specific test methods, number of samples, statistical analysis) are not provided in this summary.
§ 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.