(263 days)
The Bionx Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach ligaments to the shoulder bone, i.e., for repair of Bankart lesions or rotator cuff tears. The device may be attached to either the articular facet surface or to metaphyseal region of the bone, provided that the thickness of the cortex is less than 1.5 mm.
The Bionx Suture Anchor is a threaded screw with a square head which is 15 mm in length and 3.8 mm in diameter. The design of the screw incorporates two channels which are cut transversely through the threads on opposite sides of the device to create a groove to hold the suture. To use the suture anchor, the surgeon first prepares the implantation site by drilling a 3.5 mm hole through the cortical bone into the cancellous bone. The surgeon then inserts the square head of the anchor into the square recess on the end of the insertion tool; an interference fit securely holds the anchor in place. A suture is then placed into the channels on either side of the anchor, threaded through a groove in the insertion tool's shaft, and held in place in a slot on the insertion tool's handle. The surgeon rotates the driver to screw the anchor into the hole and uses the suture to secure the ruptured ligament to the bone at the site of the anchor insertion. The ligament remains secured to the bone throughout the healing period. after which the anchor gradually degrades and is completely absorbed by the body. Thus, there is no need to surgically remove the anchor.
The provided text is a 510(k) summary for the Bionx Biodegradable Threaded Suture Anchor from 1998. This type of regulatory document is used to demonstrate substantial equivalence to previously marketed devices and does not typically include detailed studies of the device's performance against specific acceptance criteria in the same way a clinical trial or a modern AI/software device would.
Based on the provided text, the "acceptance criteria" and "study" described are focused on proving substantial equivalence to predicate devices through technical characteristic comparison and performance testing for mechanical properties, rather than effectiveness in a clinical setting with human readers or AI.
Here's an analysis based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable table format, but are implied by the comparison to predicate devices and the required mechanical properties for a suture anchor. The "performance" is a qualitative statement of adequacy for intended use.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Similar indications for use | The Bionx Suture Anchor is intended for use to anchor the suture to the bone in orthopedic procedures to reattach soft tissue to bone in the shoulder, similar to predicate devices. |
| Substantial Equivalence: Similar principles of operation | Similar principles of operation to predicate devices. |
| Substantial Equivalence: Similar technical characteristics | The Bionx Suture Anchor possesses similar technical characteristics to predicate devices. Minor differences in configuration (e.g., screw anchor vs. barbed/wedge) and materials (biodegradable polymer vs. titanium/polyglyconate) do not raise new safety/effectiveness questions as confirmed by performance testing. |
| Mechanical Strength: Adequate pullout strength for intended use | Performance data confirms adequate pullout strength. |
| Mechanical Strength: Adequate torsional strength for intended use | Performance data confirms adequate torsional strength. |
| Biocompatibility: Established for materials used | Polylactide materials are substantially the same as those used in other cleared implantable devices, and their biocompatibility is established in medical literature. |
| Degradation/Absorption: Complete absorption over time | Gradually degrades and is completely absorbed by the body. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the text. The document refers to "performance data" and "performance testing" but does not detail the methodology, sample sizes, or provenance of the data. It's likely these details would have been in the confidential 510(k) submission, not the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable and not provided. This document describes a medical device (implantable suture anchor), not a diagnostic or AI device where expert ground truth establishment for a test set would be relevant. The "ground truth" for the device's performance is its mechanical integrity and biocompatibility, likely assessed through laboratory testing.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-reader studies or for evaluating AI diagnostic performance.
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
This information is not applicable and not provided. This document pertains to a physical implantable medical device, not an AI or software device that would assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. "Standalone" performance testing in this context refers to laboratory mechanical testing (pullout strength, torsional strength), not an algorithm's performance. The document states "performance data confirms that the Bionx Suture Anchor possesses adequate pullout strength and torsional strength for its intended use," which indicates standalone mechanical testing was performed.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" is established through:
- Laboratory-based mechanical testing: Verifying pullout strength and torsional strength.
- Material characterization and literature review: Ensuring biocompatibility and degradation properties align with established knowledge for similar materials (polylactide).
- Comparison to predicate devices: Establishing substantial equivalence based on technical characteristics and indications for use.
8. The Sample Size for the Training Set
This information is not applicable and not provided. "Training set" refers to data used to train AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As above, this concept relates to AI/machine learning.
Summary of Study Referenced:
The study referenced is the performance testing mentioned in the "Technical Characteristics" and "Summary Basis for the Finding of Substantial Equivalence" sections. This testing confirmed that:
- The Bionx Suture Anchor possesses adequate pullout strength.
- The Bionx Suture Anchor possesses adequate torsional strength.
- The differences in technical characteristics (configuration, materials) from predicate devices do not raise new questions of safety or effectiveness as confirmed by this performance testing.
The specific details of these performance tests (e.g., number of samples, test conditions, quantitative results) are not included in this 510(k) summary, as it primarily focuses on demonstrating substantial equivalence to pre-existing cleared devices.
§ 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.