(27 days)
The Magnum MP bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction. ITB tenodesis: patellar ligament and tendon avulsions
The Magnum MP device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text is a 510(k) premarket notification for a medical device (Magnum MP Fixation Device) and a clearance letter from the FDA. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about a specific study designed to prove the device meets acceptance criteria or detailed performance metrics.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document focuses on substantial equivalence to a predicate device, rather than specific performance metrics against pre-defined acceptance criteria for a new study. | Not provided. The document does not present quantitative performance data for the Magnum MP Fixation Device against specific acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not applicable, as no specific study data is presented. The submission discusses the device's design and materials in comparison to a predicate device.
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)
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not provided.
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
- MRMC study: Not performed or reported. This type of study is typically related to diagnostic AI devices, and the Magnum MP is a fixation device.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This concept is relevant for AI algorithms, not for a physical fixation device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable, as no "ground truth" in the context of diagnostic accuracy is discussed for this physical device. The submission relies on demonstrating substantial equivalence in design, materials, and intended use as evidence of safety and effectiveness.
8. The sample size for the training set
- Sample size for training set: Not applicable, as this device is a physical medical device, not an AI or algorithmic system requiring a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Summary of available information from the provided text:
The provided document is a 510(k) summary, which aims to demonstrate that the new device (Magnum MP Fixation Device) is "substantially equivalent" to an already legally marketed predicate device (Magnum PI Knotless Fixation Device, K070227). The core argument is based on:
- Same intended use: "fixation of soft tissue to bone."
- Similar technical characteristics: The document states, "The Magnum MP design and technology is substantially equivalent to the existing Magnum PI Knotless Fixation Device." It also mentions "The materials are well characterized and have been used in predicate devices with similar indications."
- No new questions of safety or effectiveness: "The differences between the Magnum MP and the predicate device do not raise any questions regarding the safety and effectiveness of the implant."
In essence, the "study" for this 510(k) is the comparison and argument for substantial equivalence to a device already cleared by the FDA, rather than a de novo clinical or performance study with defined acceptance criteria and performance results for the new device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.