(73 days)
The BIOFIX® Meniscus Arrow System is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., "red-red" and "red-white" area) in conjunction with appropriate immobilization.
The BIOFIX® Meniscus Arrow consists of a cylindrical shaft with barbs in one end and a T-shaped head at the other end. The barbs assure that the shaft is kept in place in the capsule and the peripheral part of the meniscus, while the T-shaped head keeps the loose part of the meniscus in close proximity to the periphery. The device has a shaft diameter of 1.1 mm and is available in lengths of 10 mm, 13 mm, and 16 mm. The dimensions of the T-shaped head are 1.0 mm x 1.1 mm x 3.5 mm. A specially designed set of application instruments, made of medical grade stainless steel, are required for implantation of BIOFIX® Meniscus Arrows. The set consists of six cannulae, a blunt obturator a small drill or needle, and a piston.
The provided text describes a clinical study for the BIOFIX® Biodegradable Meniscus Arrow System. However, it does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for success. Instead, the study aims to demonstrate that the BIOFIX® Meniscus Arrow System is "at least as good as sutures" and highlights certain favorable outcomes.
Here's an attempt to structure the information based on your request, identifying what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from study design) | Reported Device Performance (BIOFIX® Meniscus Arrow Group) |
|---|---|
| Non-inferiority or superiority to sutures in healing longitudinal vertical meniscus lesions at 12 weeks. | Healing at 12 Weeks: 26 healed lesions, 3 partially healed stable lesions, 2 partially healed unstable lesions, 1 unhealed lesion (out of 32 patients). When grouped as "healed" vs. "not healed," there was a statistically significant difference in favor of the BIOFIX® group (p = 0.032) compared to the suture group (17 healed, 7 partially healed stable, 2 partially healed unstable, 5 unhealed out of 31 patients). |
| Comparable knee function scores to sutures at 12 weeks, 6 months, and 1 year. | Knee function scores were comparable in the two groups at each assessment period (12 weeks, 6 months, 1 year). |
| Comparable patient-reported status ("excellent," "acceptable," or "unacceptable") to sutures at follow-up visits. | No significant differences in the number of excellent or acceptable assessments at any visit, nor in the number of unacceptable assessments, compared to the suture group. |
| Acceptable safety profile, with no increase in serious complications (e.g., deep or superficial infections, neurological problems) compared to sutures. | No deep or superficial infections related to meniscal repair, and no serious neurological problems. The suture group had two deep infections and two superficial infections. |
| Reduced operative time compared to sutures. | Operative time was considerably less than in the suture group. |
| Fewer meniscal repair-related complications compared to sutures. | Fewer meniscal repair-related complications than in the suture group. |
Note on Acceptance Criteria: The document does not explicitly list quantitative acceptance criteria in a pass/fail format. The study's conclusion, "BIOFIX® Meniscus Arrows were shown to be at least as good as sutures," implies a non-inferiority or superiority objective.
2. Sample Size and Data Provenance
- Test Set Sample Size:
- BIOFIX® Meniscus Arrow group: 34 patients enrolled (32 with 12-week healing assessment results).
- Suture group: 34 patients enrolled (31 with 12-week healing assessment results).
- Data Provenance: Prospective, randomized, controlled trial. The country of origin is not specified in the provided text.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. Healing assessment was likely performed by the clinicians involved in the study, but their specific role in establishing "ground truth" and their qualifications are not detailed.
4. Adjudication Method for the Test Set
- The adjudication method is not explicitly mentioned. It's unclear if a blinded independent adjudication panel was used for healing assessment or if it was based on the operating surgeon's findings, etc.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study compared two surgical techniques (BIOFIX® vs. sutures) in patients, not the performance of human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not performed. This device is a physical medical implant, not an AI algorithm.
7. Type of Ground Truth Used
- Clinical Assessment: The ground truth for healing was based on clinical assessment during follow-up visits, with specific definitions:
- Complete healing: "healing in the full length of the former rupture"
- Partial healing: "a residual rupture of less than 10 mm in an otherwise stable meniscus"
- Knee function scores and patient-reported status ("excellent," "acceptable," or "unacceptable") also served as outcome measures contributing to the overall assessment.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here as this is a study evaluating a physical medical device, not a machine learning algorithm.
9. How Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for a machine learning algorithm.
§ 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.