(18 days)
The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a plate and screw system, intended to treat fractures osteotomies and non-unions of various bones, including but not limited to, the radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic bone.
The Swiss Orthopedic Solutions Inc. Small Fragment Locking Set is a plate and screw system. The available plate selection consists of straight, reconstruction, tubular, and various "T" and "L" shapes. The screws with the system are 3.6mm locking screws. The plates in the system can also accept standard spherical 2.7mm, 3.5mm and 4.0mm bone screws and cannulated bone screws. The plate features a hole that is fully threaded, allowing the use of any screw in a variety of positions. The system is available in either stainless steel or titanium.
The provided document, K031609, is a 510(k) Summary for a medical device (Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria as one would find for a novel device requiring extensive clinical trials or AI/software-as-a-medical-device (SaMD) evaluations.
Therefore, many of the requested categories (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
Here's the information that can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Materials are biocompatible. | Manufactured from biocompatible materials commonly used in the orthopedic industry. |
| Strength characteristics are comparable to predicate devices. | The plates were shown to exhibit strength characteristics comparable to the predicate devices. |
| No new indications are introduced. | No new indications have been introduced with these devices. |
Explanation of "Acceptance Criteria" for this Device:
For a 510(k) submission like this for a mechanical orthopedic implant, "acceptance criteria" is not typically stated as explicit numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC) as they would be for diagnostics or AI/SaMD. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to a predicate device. This involves showing:
- Similar Materials: The device uses materials known to be safe and effective for the intended use and similar to the predicate.
- Comparable Mechanical Performance: The device performs mechanically (e.g., strength, fatigue) equivalently or better than the predicate device under relevant testing conditions.
- Similar Intended Use and Indications: The proposed device is intended for the same clinical purpose and indications as the predicate.
- No new Safety or Effectiveness Concerns: No new questions of safety or effectiveness are raised.
If these criteria are met, the device is considered "safe and effective" by virtue of its similarity to a device already deemed safe and effective.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document refers to mechanical testing, not a clinical test set of patient data. The specific number of plates or screws tested mechanically is not provided in the summary.
- Data Provenance: Not applicable. This refers to mechanical testing data, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for diagnostic or AI/SaMD devices (e.g., using expert consensus) is not relevant for this mechanical device's 510(k) summary. The "ground truth" for the mechanical performance is established through standardized engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of clinical cases or images by experts.
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
- Not applicable. This device is a bone plate and screw system, not an AI or diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance, in terms of safety and effectiveness, is established through the mechanical performance testing demonstrating comparability to the predicate device and the biocompatibility data of the materials. There is no biological "ground truth" like pathology or outcomes data presented in this summary because it's based on substantial equivalence to an existing implant.
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set as this is not an AI/machine learning device.
§ 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.