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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

1955763

MAR - 4 1996

K 455X8

510(k) SUMMARY

BIOSCIENCE, INC. BIOFIX® Biodegradable Meniscus Arrow System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910 as Regulatory Counsel to Bioscience, Inc.

Contact Person: same as above

Date Prepared: December 20, 1995

Name of Device and Name/Address of Sponsor

BIOFIX® Biodegradable Meniscus Arrow System

Bioscience, Inc. 279 B Great Valley Parkway Malvern, PA 19355

Classification Name

Bioabsorbable orthopedic fixation device

Predicate Devices

Davis & Geck Maxon Monofilament Polyglyconate Synthetic Absorbable Surgical Sutures (PMA G840051) (Maxon sutures)
Acufex Microsurgical, Inc. T-Fix Suture Bar (K925573) and implantation instruments (K942442) (T-Fix Meniscus Fixation System)

{1}------------------------------------------------

Intended Use

Technological Characteristics and Substantial Equivalence

BIOFIX® Meniscus Arrows are bioabsorbable orthopedic fixation devices composed of self-reinforced poly-L-lactide (SR-PLLA). They possess physical and chemical properties necessary for secure 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 combination with suitable immobilization. The surgically implanted BIOFIX® Meniscus Arrows lose strength over 20 to 50 weeks in vivo; within a corresponding period of time, the meniscus rupture is healed. The implant material degrades by hydrolysis rather than by enzymatic action. The degradation product is lactic acid, a normal body metabolite, that is readily eliminated as carbon dioxide during respiration.

The BIOFIX® Meniscus Arrow System is substantially equivalent to two predicate devices: (1) Davis & Geck's Maxon sutures, approved under PMA

{2}------------------------------------------------

G840051; and (2) Acufex Microsurgical's T-Fix Suture Bar and implantation instruments (T-Fix Meniscus Fixation System), cleared under K925573 and K942442. The BIOFIX® Meniscus Arrow System is substantially equivalent to these predicate devices in that its intended use is a use subsumed within the broader indication of the Maxon sutures for soft tissue approximation and within the broader indication of the T-Fix Meniscus Fixation System for meniscal repair, and in that BIOFIX® Meniscus Arrows and its predicate devices are designed to stabilize the meniscus during the healing period.

The BIOFIX® Meniscus Arrow System, like the two predicate devices, uses standard arthroscopic portals for implantation. Both the BIOFIX® Meniscus Arrow System and the T-Fix Meniscus Fixation System are implanted with precise delivery instruments. Both BIOFIX® Meniscus Arrows and Maxon sutures are absorbed by the body, unlike the T-Fix device which is permanent unless removal is necessary because of an adverse situation.

BIOFIX® Meniscus Arrows, like the predicate devices, are supplied sterile and require good surgical technique and proper postoperative immobilization.

Although there are some differences in materials and implantation instruments and technique between the BIOFIX® Meniscus Arrows and its predicate devices, no new issues of safety and efficacy have been raised.

Nonclinical and Clinical Testing

Nonclinical Testing

Mechanical testing was carried out to determine the initial separation force between the head and shaft of the arrow and the initial pull-out force of the barbs on the arrow shaft, and these same properties under in vitro hydrolytic conditions that simulate the hydrolytic degradation of the BIOFIX® Meniscus Arrow in vivo. These results and the results of the clinical study described below demonstrated that the arrows possess sufficient strength for the period needed for healing and stabilization of the fixation site.

{3}------------------------------------------------

Clinical Testing

Arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) with BIOFIX® Meniscus Arrows was compared in a prospective, randomized, controlled trial to inside-out arthroscopic suturing with the Acufex Double Barrel System using Maxon-0 sutures. Patients returned for evaluation at two weeks, five weeks, nine weeks, 12 weeks, six months, and at one year following surgery. Complete healing was defined as healing in the full length of the former rupture, while partial healing was defined as a residual rupture of less than 10 mm in an otherwise stable meniscus.

Thirty-four patients were enrolled in each treatment group. Of the 32 patients in the BIOFIX® Meniscus Arrow group for whom 12 week healing assessment results were available, 26 were found to have healed lesions, three to have partially healed, stable lesions. two to have partially healed, unstable lesions, and one to have an unhealed lesion. Of the 31 patients in the suture group for whom 12 week healing assessment results were available, 17 were found to have healed lesions, seven to have partially healed, stable lesions, two to have partially healed, unstable lesions, and five to have an unhealed lesion. Results were also analyzed for each treatment group by length of tear, distance from joint capsule to lesion, and operative location of meniscal tear. When the "healed" versus "not healed" results were grouped, there was a statistically significant difference in favor of the BIOFIX® Meniscus Arrow group (p == ().032).

Knee function scores were analyzed for each treatment group at the 12 week, six month, and one year visits; scores were comparable in the two groups at each assessment. In addition, patients evaluated their own status at the follow-up visits and rated their status as "excellent," "acceptable," or "unacceptable." There were no significant differences in the number of excellent or acceptable assessments at any visit in the two groups, nor in the number of unacceptable assessments.

{4}------------------------------------------------

There were no deep or superficial infections related to meniscal repair in the BIOFIX® Meniscus Arrow group, nor were there any serious neurological problems. There were two deep infections in the suture group and two cases of superficial infection related to meniscal repair in the suture group; no serious neurological problems were reported in this group.

In summary, BIOFIX® Meniscus Arrows were shown to be at least as good as sutures in the treatment of bucket-handle lesions. In this study, operative time was considerably less, more lesions were healed 12 weeks postoperatively, and there were fewer meniscal repair-related complications in the BIOFIX® Meniscus Arrow group than in the suture group, while functional results were comparable.

Regulation Number and Section

§ 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.