(68 days)
The Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE: Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components are used for: Stabilization of soft tissues and fractures, Polytrauma/multiple orthopedic trauma, As treatment adjunct for vertically unstable pelvic fractures, Arthrodeses and osteotomies with soft tissue problems; failures of total joints, Treatment of fractures stabilized with limited internal fixation, Non-unions/septic non-unions, Intra-operative reductions/stabilization tool to assist with indirect reduction, Unilateral rectilinear bone segment transport or leg lengthening.
MEDIUM: Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
SMALL: Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, and foot. Specifically, the components can be used for: Preliminary fixation before ORIF, Unstable fractures of the distal radius (both intra and extra-articular), Open and/or comminuted bilateral fractures, Open and or combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement, Fracture dislocations, Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations), Pediatric open fractures with bone loss and osteotomies.
MINI: Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for: Comminuted fractures of phalanges and metacarpals, Displaced intra-articular fractures, Segmental bone loss, Fractures that do not allow stable internal fixation, Fractures with associated complex soft tissue injuries, Tumor resections.
The Reprocessed External Fixation Device consists of the standard bridge elements (rods, articulating and telescoping components), and connection elements (clamps) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Anchorage elements are not included in the Reprocessed External Fixation Device.
The provided document describes a 510(k) premarket notification for a Reprocessed External Fixation Device. This is a regulatory filing for a medical device that aims to demonstrate its substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.
As such, the document does not contain the typical information regarding acceptance criteria and a study design that demonstrates the device meets those criteria in the way a new device would. Instead, the "study" described is primarily focused on demonstrating functional equivalence to existing devices through bench testing and process validation.
Here's an analysis of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Characteristics: Reprocessed devices must demonstrate appropriate functional characteristics. | "Functional and Representative samples of Reprocessed External Fixation Devices underwent bench testing to demonstrate appropriate functional characteristics." (No specific quantitative metrics or results are provided, simply that they "demonstrate appropriate functional characteristics.") |
| Cleaning Procedure Validation: The reprocessing cleaning procedure must be validated. | "Process validation testing was done to validate the cleaning procedure." (No specific validation criteria or results are provided.) |
| Visual and Functional Testing: All reprocessed products must pass visual and functional inspection prior to release. | "In addition, the manufacturing process includes visual and functional testing of all products prior to release." (This describes an internal quality control step rather than specific performance data from a study.) |
| Substantial Equivalence: The reprocessed device must be substantially equivalent to the predicate device in functional design, materials, and indications for use. | "The External Fixation Device reprocessed by SterilMed is substantially equivalent to counterpart devices originally manufactured by Synthes. This conclusion is based upon the devices' similarities in functional design, materials and indications for use." (This is the overarching conclusion of the 510(k) submission, not a specific performance outcome against a metric.) The predicate devices are listed as Synthes Reprocessed External Fixation Devices (K033158), Synthes Large External Fixation Clamps MR Safe (K031428) and Synthes Medium External Fixation System MR Safe (K040258). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states "Functional and Representative samples" were used for bench testing. The exact number of samples is not specified.
- Data Provenance: The data is likely from retrospective bench testing conducted by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. The country of origin of the data would therefore be the USA. This is not a clinical study involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The concept of "ground truth" as typically understood in AI/medical imaging studies (e.g., pathology, expert consensus on disease presence) does not apply directly here. The "ground truth" for this type of submission is the functional and material specifications of the original, new devices and established regulatory standards for reprocessing.
- The document does not mention any external experts establishing ground truth for the test set. The validation would have been performed by SterilMed's internal engineering and quality personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable here. Adjudication methods like 2+1 are used in clinical studies where conflicting expert opinions need to be resolved for ground truth labeling. This submission relies on objective bench test results and process validation.
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
- No MRMC comparative effectiveness study was done. This is a submission for a physical medical device (external fixation device, reprocessed), not an AI algorithm for diagnostic imaging. Therefore, the question of human readers improving with AI assistance is not relevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. Again, this is for a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional and material testing, the "ground truth" would be considered the established engineering specifications and performance characteristics of the originally manufactured (new) devices, as well as relevant industry standards for mechanical properties and material integrity, and regulatory requirements for device reprocessing and sterility. This is not ground truth in the sense of a medical diagnosis.
8. The sample size for the training set
- This device is a reprocessed physical medical device, not an AI model. Therefore, the concept of a "training set" for an algorithm is not applicable.
9. How the ground truth for the training set was established
- As mentioned above, there is no training set for an AI algorithm in this context.
In summary:
This 510(k) submission establishes substantial equivalence for a reprocessed external fixation device. The "study" involves bench testing of representative samples to confirm functional characteristics and process validation for the cleaning procedure. The core argument is that the reprocessed device performs comparably to the original, new device and other legally marketed reprocessed predicate devices. It does not involve clinical trials, expert consensus on patient data, or AI algorithm validation.
§ 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.