(183 days)
The ODRC-DHS System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
The ODRC-Dynamic Hip Screw System consists of non-sterile ODRC-DHS Plate, ODRC-DHS Screw, ODRC-DHS Blades, compression screw, and 4.5 mm cortex screw. The ODRC-DHS Plate is a straight with an angled barrel portion that accepts ODRC-DHS Screw and ODRC-DHS Blades. The barrel angle is 135° and length of 36 mm. The plates are available in multiple lengths (lengths ranging from 46 mm to 206 mm) to accommodate differing patient anatomy. The plate accepts DHS Helix Screw (lengths ranging from 75 mm to 130 mm) and 4.5 mm cortex screws.
Here's an analysis of the provided text regarding the ODRC-Dynamic Hip Screw System, focusing on acceptance criteria and performance study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static Four-Point Bending Test (ASTM F382)
- Dynamic Four-Point Bending Test (ASTM F382)
- Static Axial Compression Bending Test (ASTM F384)
- Dynamic Axial Compression Bending Test (ASTM F384) | The ODRC-Dynamic Hip Screw System performs as well as or better than the predicate device (SYNTHES DHS System K981757) in all conducted mechanical tests. (Specific quantitative results are not provided in the summary). |
| Material: - Medical grade 316L stainless steel | Meets ASTM F138 & ASTM F139/lSO 5832-1. |
| Technical Characteristics: - Plate barrel angle: 135°
- Plate barrel length: 36 mm
- Plate lengths: 46 mm to 206 mm
- DHS Helix Screw lengths: 75 mm to 130 mm | The device meets these specified technical characteristics. (Implicitly, as it forms part of the device description and is compared to the predicate). |
| Intended Use: - Fixation of fractures of the proximal femur (femoral neck, trochanteric, pertrochanteric, or Intertrochanteric zones). | The device's indications for use are consistent with those of the predicate device, indicating it meets the intended use criteria. |
| Substantial Equivalence: | Demonstrated to be substantially equivalent to the predicate system with respect to technical characteristics, performance, and intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "Mechanical testing... was conducted," but does not provide details on the number of components or systems tested.
- Data Provenance: The testing was conducted by the "ORTHOPAEDIC DEVICE RESEARCH CENTER" at "National Yang-Ming University, Taipei 11221, Taiwan." This suggests the tests were performed in Taiwan. The study appears to be retrospective in the sense that it's a comparison to an existing predicate device, and the bench testing itself is a controlled laboratory study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study involves mechanical bench testing of a medical device, not a diagnostic or clinical study requiring expert consensus for ground truth. The "ground truth" here is objective physical measurements and material specifications.
4. Adjudication method for the test set
Not applicable. As this is mechanical testing, there is no human adjudication process involved in establishing results. The results are obtained directly from test equipment based on established ASTM standards.
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 is a submission for a mechanical fixation device, not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The performance evaluated is the physical, mechanical behavior of the hip screw system itself.
7. The type of ground truth used
The ground truth for the acceptance criteria and performance assessment is based on objective mechanical properties and material specifications as defined by relevant ASTM and ISO standards (ASTM F382, ASTM F384, ASTM F138, ASTM F139/lSO 5832-1). The performance is measured against these established engineering standards and compared directly to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" in this type of submission for a mechanical device. The device's design and manufacturing are based on established engineering principles and materials science, not machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this query is irrelevant to the provided information.
§ 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.