BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM

• K Number: K982721
• Device Name: BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
• Manufacturer: BIONX IMPLANTS, INC.
• Date Cleared: 1999-02-17 ( 197 days)
• Product Code: JEY
• Regulation Number: 872.4760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K972783 , K972919 , K971870 , K982139

Intended Use

The BioSorbFX 2.0/2.4 Bioabsorbable Fixation System ("BioSorbFX 2.0/2.4 System") is intended for use in trauma and reconstructive procedures in the midface and maxilla. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface and maxilla, and in orthognathic and reconstructive procedures of the midface or maxilla. An instrumentation set which is used to implant the fasteners to secure the plates to bone is included with the BioSorbFX 2.0/2.4 System. The BioSorbFX 2.0/2.4 System is not intended for use in mandibular applications.

Device Description

The BioSorbFX O/M System is a system of bone plate and mesh configurations affixed to bone by 2.0 mm and 2.4 mm screws. The system also includes a 2.8 mm emergency screw and accessory instrumentation for implantation of the screws. The 2.0 mm screw has a minor (shaft) diameter of 1.45 mm and is available in lengths of 4, 6, 8, 10, 12, 14, 16, 18 mm. The 2.4 mm screw has a minor diameter of 1.55 mm and is provided in lengths in 4, 6, 8, 10, 12, 14, 16, 18, 20 ,24 mm. The 2.8 mm emergency screw has a minor diameter of 1.95mm and lengths of 4, 6, 8, 10, 12, 14, 16, 18, 20 ,24 mm. The 2.8 mm screw is intended to serve as an emergency screw for the 2.4 mm screw and the 2.4 mm screw can be used as an emergency screw for the 2.0 mm screw. The accessory instrumentation set contains bone drills, bone taps, a screwdriver and a plate bender. The accessory instruments are fabricated from stainless steel (400 series). The bone plates will be available in 1.2 mm and 1.4 mm thick plates of various shapes. The thickness of the mesh plates is 1 mm. The bone plates may be cut or bent at room temperature with being heated. The BioSorbFX O/M System stabilizes bone during healing in conjunction with postoperative immobilization. The system also includes 5x5 hole and 5x10 hole rectangular meshes. The BioSorbFX O/M System will be provided sterile and pyrogen free. The components are to be sterilized via gamma radiation. The components of the system are made from poly-L/DL-lactide {P(L/DL)LA} copolymer. The P(L/DL)LA copolymer is a blend of 70 molar percent L-lactide and 30 molar percent D,L-lactide and maintains its strength for 12 to 22 weeks. The P(L/DL)LA copolymer is a self-reinforced copolymer. The P(L/DL)LA copolymer degrades in vivo by hydrolysis into lactate and glutate monomers. The polymer matrix is reinforced with P(L/DL)LA fibers that are oriented axially. The surface of the BioSorbFX O/M System plates is smooth, with an average roughness (Rg) of 2 - 8 pm. The BioSorbFX O/M System is sold sterile and is for single use only. The devices are sterilized by gamma irradiation with a minimum dose of 25 kGy. The SAL is 10°. Each plate is packaged in an individual paper board holder. One to six screws are packaged in a paper board holder. Both the plates and screws are sealed in an aluminum foil pouch, which is then sealed in a Tyvek® pouch and placed in cardboard boxes.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:

Acceptance Criteria and Device Performance (Based on Clinical Study)

The document primarily discusses a clinical study to support the safety and effectiveness of the BioSorbFX O/M System. The "acceptance criteria" are implicitly derived from the positive outcomes observed in this study, demonstrating that the device performed as expected for its intended use (maxillofacial fixation).

Acceptance Criteria (Implied from favorable clinical outcomes)	Reported Device Performance (Clinical Study)
Sufficient strength and stability despite plate bending.	None of the plates broke during bending for surgical placement, even with internal delamination. They functioned with sufficient strength and stability.
Good screw fit and integrity.	293 (96.1%) of 305 screws had good fit. Damage to screw head slits in 18 cases did not influence fit.
No delayed bone union.	No cases of delayed bone union.
Clinical stability of operated jaws.	At six weeks, all operated jaws were clinically stable.
Absence of chronic inflammatory reaction, wound dehiscence, or plate exposure.	At six weeks, no evidence of chronic inflammatory reaction, wound dehiscence or plate exposure.
Stable occlusion without need for hardware removal.	Six weeks postoperatively, occlusion was stable; no need to remove plates and screws because of malocclusion. Minimal changes between 6 weeks and 3 months.
Comparable short-term stability to established methods.	Short-term stability appeared better than wire osteosynthesis and similar to metal devices.
Low incidence and manageability of adverse events related to infection.	One patient developed an infection (3 weeks post-op) that resolved with intraoral incision and antibiotics.
Acceptable screw failure rate and successful remediation.	12 screws deficient in fit (6 broke, 6 insufficient fit); all were replaced or addressed with new screw insertion, with no other adverse effects.
Material properties (chemical composition, biocompatibility, degradation rate, strength retention) meet established characteristics for bioabsorbable devices.	Material (P(L/DL)LA copolymer) well-characterized, used in other cleared devices, degrades within 2-3 years (completely resorbed in 4 years), maintains strength for 12-22 weeks, equivalent to other bioabsorbable polylactide materials. Mechanical strength, bending, shear, and pull-out tests performed and deemed "acceptable."

Study Details:

1. Sample Size used for the Test Set and the Data Provenance:

   • Clinical Study Sample Size: 10 patients (5 female, 5 male).
   • Devices Used: 62 plates (40 in maxilla, 20 in mandible, 2 in chin) and 305 screws.
   • Data Provenance: The document does not explicitly state the country of origin for the clinical study. It is a prospective clinical study as it involved patients undergoing specific surgical procedures and follow-up.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • The document describes a clinical study, implying that the "ground truth" (e.g., bone union, stability, absence of complications) was established by the treating surgeons and specialists involved in the follow-up of the 10 patients.
   • The specific number and qualifications of these experts (e.g., "radiologist with 10 years of experience") are not explicitly stated in the provided text.

3. Adjudication Method for the Test Set:

   • The document describes a clinical study where patient outcomes were observed and reported. It does not mention any specific adjudication method (e.g., 2+1, 3+1 consensus) for assessing the outcomes of the clinical study. The results appear to be direct observations and clinical assessments by the medical team.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (fixation system) not an AI-based diagnostic or imaging device used by readers.
   • The study did compare short-term stability to "wire osteosynthesis" and "metal devices," indirectly assessing comparative effectiveness, but not in the context of human readers + AI vs. human readers alone.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No, a standalone algorithm-only performance study was not done. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • For the clinical study, the ground truth was clinical outcomes data (e.g., clinical stability, absence of infection, bone union, occlusion stability), expert clinical assessment, and direct observation by medical professionals during follow-up visits (6 weeks and 3 months).
   • For the material and mechanical testing, the ground truth was laboratory measurements and scientific testing against established specifications and prior knowledge of the material.

7. The Sample size for the training set:

   • The concept of a "training set" is not applicable here as this is a traditional medical device, not a machine learning model. The study described is a clinical validation study for the device itself.
   • However, the material used (P(L/DL)LA copolymer) had a history of use in "other Bionx, Inc. predicate implant devices" which could be considered analogous to a "training" or prior experience set for the material's properties. No specific sample size for this prior experience is given, other than the general statement of prior use.

8. How the ground truth for the training set was established:

   • As "training set" doesn't directly apply, we refer to the material's prior use. The ground truth for the material's suitability was established through:
     • Chemical characterization (component analysis, impurity levels, molecular weight, intrinsic viscosity).
     • Toxicological biocompatibility testing.
     • FDA Master File 357 reference (by Boehringer Ingleheim), indicating established regulatory acceptance of the material.
     • Performance in other cleared devices (e.g., Biodegradable Threaded Suture Anchor (K972783), BioSorb Endobrow Screw (K972919), BioSorbFX 1.5/2.0 Bioabsorbable Fixation System (K982139)). This suggests that the material had already demonstrated acceptable clinical performance and safety in previous applications.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.