(395 days)
The restor3d Utility Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal Cuneiform osteotomies
- · Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
- · Hindfoot osteotomies such as Ankle fusion and Subtalar fusion
The restor3d Utility Wedges are intended for use with supplemental fixation. The restor 3d Utility Wedges are not intended for use in the spine.
The proposed Utility Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for opening and lengthening osteotomy procedures of the foot, including Lapidus and Subtalar.
The provided text is a 510(k) Summary for the restor3d Utility Wedge. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by benchtop performance testing. However, it does not contain the detailed information necessary to answer all parts of your request, particularly regarding acceptance criteria and study details that would typically be found in a clinical study report or a more comprehensive validation summary for a device involving AI or human interpretation.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions three benchtop performance tests:
- Static Compressive Strength
- Dynamic Compressive Strength
- Expulsion
It states, "No new questions of safety or effectiveness were identified during device testing." However, specific acceptance criteria (e.g., minimum compressive strength in Newtons, or maximum displacement under dynamic load) and the reported device performance against these criteria are not provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The summary refers to "benchtop performance tests" rather than tests involving 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)
This information is not applicable as the summary describes benchtop tests, not tests involving expert interpretation or medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the summary describes benchtop tests, not tests involving expert interpretation or medical imaging.
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
There is no mention of a multi-reader multi-case (MRMC) study, AI assistance, or human readers. This device is a physical implant, not an AI-enabled diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is a physical medical device (an osteotomy wedge), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the benchtop tests, the "ground truth" would be the engineering specifications and relevant testing standards (e.g., ASTM or ISO standards for mechanical testing of implants), but these specific standards or criteria are not detailed in this summary.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI model.
In summary: The provided document is an FDA 510(k) summary for a physical orthopedic implant. It outlines the device's indications for use and states that substantial equivalence was supported by benchtop mechanical testing. However, it does not provide the detailed acceptance criteria, specific performance results, or study methodologies that would be relevant for an AI/software device or a clinical study involving human interpretation. The questions regarding AI, human readers, ground truth establishment for training/test sets, and expert qualifications are not applicable to the information contained within this specific 510(k) summary.
§ 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.