(277 days)
The BioSorbFX O/M 2.0/2.4 System is intended for use in trauma and reconstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes bone during healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).
The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for:
- Mandibular tumor resection.
- Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
- Significant comminuted fractures, including significant bone loss; of the mandible.
- Intermaxillary fixation without an appropriate external fixation by other means.
The BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation Systems consists of various place configurations, which are attached to the bone by 2.0, 2.4 and 2.8mm/threaded fasteners (i.c., screws) of various lengths. The specifications for the BioSprbFXTM O/M 2.0/2.4 System plates and fastencrs will require a self-reinforced copolymer derived from Llactide and D/L-lactide ("PLA copo."), which consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide, with strength retention time 18-36 weeks.
Properly used, in the presence of adcquate immobilization, absortuble BioSprtFX'"> O/M 2.0/2.4 System implants stabilize bone during healing. The BioSorbFX™ O/M 2.0/2.4 System implants gradually lose their strength during 18-36, weeks. Biodegradation takes place within two to three years. The BioSorbFX™ Ont 2.0/2.4 System includes an instrument set containing bone drills, bone taps, screwdrivers, plate benders and cheek retractors.
Here's an analysis of the provided text regarding the BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific, novel acceptance criteria through extensive clinical trials for efficacy and safety. Therefore, much of the requested information (like detailed acceptance criteria and standalone study results, detailed ground truth establishment for a training set, or MRMC studies) is generally not found in a 510(k) summary for this type of device. The focus is on demonstrating that the new device is as safe and effective as existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary for a bone fixation system, the "acceptance criteria" are primarily related to material specifications, mechanical properties, and equivalence in intended use and operating principles to predicate devices. The document does not explicitly state quantitative "acceptance criteria" in the way one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance is implicitly "accepted" if found substantially equivalent to the predicate devices.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Material Composition: Self-reinforced copolymer of L-lactide and D/L-lactide. | Consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide. |
| Strength Retention Time: Adequate for stabilization during healing. | Strength retention time: 18-36 weeks. Stabilizes bone during healing in conjunction with appropriate postoperative immobilization. |
| Biodegradation Time: Complete absorption within a reasonable timeframe. | Biodegradation takes place within two to three years. |
| Intended Use: Similar to predicate devices (midface, maxilla, mandible trauma/reconstruction). | Intended for use in trauma and reconstructive procedures in the midface, maxilla, and mandible. Specifically, for surgical repair in trauma and orthognathic/reconstructive procedures. This is the same intended use as the predicate device BioSorbFX™ 2.0/2.4 System (K982721) and similar to other cited predicates. |
| Operating Principles: Same as predicate devices. | Uses the same operating principles as BioSorbFX 2.0/2.4 System (K982139) and other specified predicate devices (Biomet LactoSorb, Synthes, Lorenz, Macropore). |
| Basic Design: Same as predicate devices. | Incorporates the same basic design as BioSorbFX 2.0/2.4 System (K982139) and same design principles as other specified predicate devices. Consists of various plate configurations and 2.0, 2.4, and 2.8mm threaded fasteners. |
| Manufacturing/Packaging/Sterilization: Same as predicate devices. | Manufactured, packaged, and sterilized using the same machinery and processes as BioSorbFX 2.0/2.4 System (K982139). |
| Instrument Set: Identical/Substantially equivalent to predicate devices. | Instrument set is identical with previously cleared BioSorbFX™ 2.0/2.4 System (K982721) and substantially equivalent with BioSorbFX™ 1.5/2.0 System (K982139) and BioSorb™ Endobrow Screw™ (K972919). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an AI/software algorithm evaluation. Instead, the submission relies on:
- Engineering/Bench Testing: Implied by the discussion of material properties (strength retention, biodegradation). No specific sample sizes for these tests are provided in this summary.
- Comparison to Predicate Devices: The primary "test" is to demonstrate substantial equivalence to previously cleared devices. This involves comparing specifications, intended use, operating principles, and materials. The "sample" in this case is the new device itself, being compared element-by-element to the predicate devices.
- Data Provenance: Not applicable in the context of human data. The "data" here refers to the device's design, material properties, and intended function.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a bioabsorbable fixation system, not a diagnostic AI system requiring expert-established ground truth from medical images or patient data. The "ground truth" for this submission is whether the device's characteristics (material, strength, design, intended use) are substantially equivalent to legally marketed predicate devices, which is assessed by the FDA based on the submission's technical details.
4. Adjudication Method for the Test Set
Not applicable. There's no "adjudication method" in the sense of resolving discrepancies in expert interpretations, as there's no expert labeling task described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a surgical implant designed to stabilize bone, not a diagnostic tool, and therefore an MRMC study is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the evaluation of the device's physical and mechanical properties (material composition, strength retention, biodegradation time) can be considered a "standalone" assessment of the device's intrinsic characteristics. However, this is not an "algorithm-only" standalone performance as typically discussed for AI/software. The device itself (the implant) is the "standalone" subject of the evaluation, separate from its use in a patient (human-in-the-loop). No specific study in this format is detailed beyond the general statements of properties.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices already on the market. The BioSorbFX™ O/M 2.0/2.4 System is deemed safe and effective because it is substantially equivalent to these predicate devices. The factual basis for this substantial equivalence includes:
- Material Science/Engineering Data: Data on the polymer composition, strength, and degradation characteristics.
- Design Specifications: Detailed blueprints and specifications of the plates, screws, and instrument set.
- Previous FDA Clearances: The regulatory history and clearance (510(k) numbers K982139, K982721, K981666, etc.) of the predicate devices serve as the "ground truth" for what is considered safe and effective for this product type.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
§ 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.