(48 days)
The OUESTUSTM Polyester Suture Soft Tissue Anchor System is indicated for the following:
- ownig. lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- repair of elbow instability secondary to biceps tendon detachment, tennis elbow, of ulnar or radial collateral ligament tear/separation;
- repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments
The OUESTUSTM Polyester Suture Soft Tissue Anchor System, size 7.5mm, is a single use, sterile, preassembled kit consisting of a bone anchor, a suture, and a disposable instrument driver, and is an additional size offering to the QUESTUSIM Polyester Suture Soft Tissue Anchor System. The anchor is manufactured from titanium alloy and threaded into bone. Soft tissue is secured to the implant site with suture.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (OUESTUS™ Polyester Suture Soft Tissue Anchor System) and primarily describes the device, its intended use, and a high-level summary of testing.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in a quantifiable manner (e.g., minimum tensile strength, maximum displacement). The document mentions "can be expected to meet or exceed the in vivo performance of the 5.0mm anchor" but doesn't define specific thresholds for performance.
- Reported Device Performance: No specific numerical performance metrics are provided for the 7.5mm anchor or the 5.0mm anchor.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only states "The 7.5mm QUESTUS™ Polyester Suture Soft Tissue Anchor System was tested...". It does not give the number of samples used in this testing.
- Data Provenance: Not specified. It doesn't mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This section of the document describes a mechanical device and its performance, not a diagnostic or AI-driven system that would require expert-established ground truth for a test set. The testing described is physical performance testing (likely biomechanical).
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an MRMC study. It is mechanical performance testing of a soft tissue anchor system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Not explicitly stated in the context of 'ground truth' for an AI/diagnostic system. For mechanical testing, the "ground truth" would be the physically measured properties and behavior of the device under test conditions. The document implies compliance with a "Draft Guidance Document for Testing Bone Anchor Devices, April 1, 1993," which would presumably define the methods for establishing these physical truths.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
In summary, the provided text describes a 510(k) summary for a physical medical device and primarily focuses on its description, intended use, and a general statement about performance testing, rather than detailed acceptance criteria and study results for an AI or diagnostic device as implicitly requested by the structure of your questions.
§ 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.