(55 days)
Shoulder - bankart repair
Hand/wrist - ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment
Skull - lateral canthoplasty
Foot/ankle - hallux valgus reconstruction, midfoot reconstructions
Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
The provided document is a 510(k) summary for the Li Medical LM Anchor, a bone fixation device. It describes the device, its intended use, and its comparison to a predicate device, along with performance data. However, it is not a study that contains detailed acceptance criteria or extensive performance data suitable for a detailed table as requested in the prompt.
Here's an analysis based on the available information, with significant limitations due to the nature of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a formal table. Instead, it makes a qualitative comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to or exceeding the mean pullout strength of the Mitek anchor (predicate device). | "The mean pullout strength of the LM Anchor was substantially equivalent to or exceeded the mean pullout strength of the Mitek anchor." |
Limitations: The document does not provide specific numerical values for pullout strength for either the LM Anchor or the Mitek anchor, nor does it define the threshold for "substantially equivalent" in terms of a specific percentage or statistical margin.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "cadaver specimen" but does not quantify the number of specimens or anchors tested.
- Data Provenance: "Pre-clinical testing in cadaver specimen." This implies the data is retrospective as the tests were completed before the 510(k) submission. The country of origin is not specified, but the applicant is a US company (Shelton, CT).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This type of study (mechanical pullout strength in cadaver specimens) does not typically involve human experts establishing a "ground truth" in the way clinical studies with diagnostic devices might. The "ground truth" is the measured mechanical property (pullout strength).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 for consensus) are relevant for studies involving human interpretation or subjective assessments, which is not the case for a mechanical pullout strength test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where multiple readers interpret clinical cases, often to assess the impact of AI assistance. The LM Anchor is a medical device for bone fixation, and its performance is evaluated through mechanical testing, not diagnostic interpretation.
6. Standalone (Algorithm Only) Performance
Not applicable. The LM Anchor is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this study was mechanical measurements of pullout strength. This is an objective, quantitative physical property.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning algorithm, so there is no "training set" in the computational sense. The "training" for the device would be its design and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set as it pertains to AI/ML.
§ 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.