(177 days)
The dynaMX™ Compression Staple is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
Fixation of proximal tibial metaphysis osteotomy
The dynaMX Compression Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
The dynaMX Compression Staples are made of biocompatible Nitinol. The legs of the staple are designed to exhibit superelastic properties at room temperature.
Staples with a bridge length of 11mm and longer are designed with a bridge that can be bent to contour to the bone surface.
This document is a 510(k) Premarket Notification from MX Orthopedics, Corp. for their dynaMX™ Compression Staple. It declares substantial equivalence to predicate devices and describes the device, its indications for use, and the studies conducted to support its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists the types of laboratory studies conducted to "verify the suitability...establish Substantial Equivalence...and confirm reproducibility." The implication is that the device met the internal acceptance criteria for each of these tests to demonstrate substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Elastic Static Bending (Suitability for intended use) | Conducted |
| Bending Fatigue (Suitability for intended use) | Conducted |
| Staple Pull-Out Force (Suitability for intended use) | Conducted |
| Corrosion (Biocompatibility and Durability) | Conducted |
| Package Seal Strength (Reproducibility & Shelf-life) | Conducted |
| Biocompatibility (Material safety) | Well-established for Nitinol (referenced publication appended) |
| Shelf-life / Stability | Protocol appended |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "A series of laboratory studies (bench tests)" but does not specify the sample size for any of these tests. It also does not provide information on the data provenance in terms of country of origin or whether the studies were retrospective or prospective. These are bench tests, so they would not typically involve human 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 section is not applicable as the studies conducted were "laboratory studies (bench tests)" on the device itself, not studies involving human interpretation or clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the studies were bench tests and did not involve human adjudication for establishing ground truth.
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 an MRMC comparative effectiveness study involving human readers or AI in the provided document. The current submission is for a medical device (compression staple), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the submission is for a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the engineering specifications and performance targets defined for each test (e.g., a specific pull-out force, a bending fatigue limit). These are inherent properties measured directly from the device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific tests.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this submission is for a physical medical device and does not involve machine learning or AI.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
§ 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.