(75 days)
The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibularly in osteopenic bone.
Washers are intended to be used in conjunction with bone screws.
The A.L.P.S.® Small Fragment System is a titanium alloy (Ti-6Al-4V) plate and screw system that fuses locking screw technology with conventional plating techniques.The subject device consists of plates, The devices are available in sterile and nonsterile options, and vary by sizes and number of holes, making the device suitable for a wide range of patient anatomy and needs.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification summary for a medical device called the "A.L.P.S. Small Fragment Plating System." As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific study designed to "prove" the device meets those criteria in the way a clinical trial for an AI diagnostic might.
Key takeaway: The document confirms that for this type of device (metallic bone fixation system), clinical data and conclusions were not needed. The substantial equivalence is based on technological comparison and non-clinical tests related to MRI compatibility. Therefore, many of the questions related to acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert adjudication, or MRMC studies are not applicable in this context.
Here's the information that can be extracted or inferred from the provided text, with clarifications where questions are not applicable:
1. A table of acceptance criteria and the reported device performance
For this device, the "acceptance criteria" are related to established standards for materials and non-clinical performance, primarily demonstrating MR compatibility and structural integrity through existing test methods. The document doesn't provide specific quantitative acceptance criteria or performance metrics in a table format for this specific device's novel performance. Instead, it states that the device's technological characteristics are similar to predicates and that non-clinical tests were conducted.
| Acceptance Criteria (Inferred from device type and testing) | Reported Device Performance (Summary from document) |
|---|---|
| Material Composition: Titanium alloy | Ti-6Al-4V (Same as predicates) |
| Functional Principle: Locking screw technology with conventional plating | Fuses locking screw technology with conventional plating techniques (Same as predicates) |
| MR Compatibility - RF Heating: Conforms to ASTM F2182 | Evaluation performed to support MR Conditional labeling. |
| MR Compatibility - Displacement Force: Conforms to ASTM F2052 | Evaluation performed to support MR Conditional labeling. |
| MR Compatibility - Magnetic Torque: Conforms to ASTM F2119 | Evaluation performed to support MR Conditional labeling. |
| MR Compatibility - Image Artifact: Conforms to ASTM F2213 | Evaluation performed to support MR Conditional labeling. |
| Intended Use/Indications: Alignment with predicates | Identical indications to predicate devices. |
| Safety and Effectiveness: No new questions raised by differences from predicates | No different questions of safety and effectiveness; at least as safe and effective as predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. The submission states: "Clinical data and conclusions were not needed for this device." The tests performed are non-clinical (e.g., MRI compatibility on a device, not on patient data).
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)
- Not Applicable. As no clinical data or test sets requiring expert ground truth were used for this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As no clinical data or test sets requiring expert adjudication were used for this 510(k) submission.
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 metallic bone fixation system, not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a metallic bone fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. Clinical ground truth was not required for the non-clinical tests performed. The "ground truth" for the device's properties would be based on engineering specifications, material standards, and physical testing outcomes against those standards.
8. The sample size for the training set
- Not Applicable. This device is a physical medical device, not an AI/ML algorithm. There is no training set in this context.
9. How the ground truth for the training set was established
- Not Applicable. This device is a physical medical device, not an AI/ML algorithm. There is no training set or ground truth for such a set in this context.
§ 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.