Search Results

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.

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.

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Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).

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.

Let's break down the information provided about the K981755 device, "LM Anchor," in relation to your request.

Acceptance Criteria and Device Performance for LM Anchor (K981755)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The K981755 submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. In this context, the "acceptance criteria" are implicitly tied to demonstrating that the new device performs at least as well as, or equivalently to, the predicate device in relevant performance characteristics. For a bone anchor, pullout strength is a critical mechanical property.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "Pre-clinical testing in cadaver specimen," implying a certain number of cadaver specimens were used, but the exact count of anchors tested or specimens involved is not provided.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified, but "Pre-clinical testing" generally implies a prospective study design conducted for the purpose of the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. This device is a bone anchor, and the performance assessment (pullout strength) is a physical, objective measurement, not typically subject to interpretation by human experts to establish "ground truth" in the way a diagnostic imaging device would be.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the "ground truth" is a direct physical measurement (pullout strength), there's no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret medical images. The LM Anchor is a medical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? This question is generally relevant for AI/ML algorithms. The LM Anchor is a mechanical device, so the concept of an "algorithm only" performance study does not apply. The performance data presented (pullout strength) is the standalone performance of the device.

7. Type of Ground Truth Used

• Type of Ground Truth: Objective physical measurement: Pullout Strength. This is a direct, quantifiable mechanical property of the device when implanted in bone.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The LM Anchor is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The engineering design and manufacturing processes are based on established biomechanical principles and material science, not machine learning.

9. How the Ground Truth for the Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set." The performance characteristics of the device are validated through pre-clinical testing, comparing its physical properties to those of an established predicate device.

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Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis), Bladder Neck Suspension.

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 a medical device called the "LM Anchor" (K960825). This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and performance metrics in the way that would typically be described for an AI-powered diagnostic device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this particular type of regulatory submission for a physical medical device like a bone anchor.

However, I can extract the information related to performance data as presented in the summary, which serves as the "study" demonstrating the device meets the implied acceptance criteria of being substantially equivalent to predicate devices.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Narrative on Acceptance Criteria and Study:

The primary acceptance criterion for the LM Anchor, as presented in this 510(K) summary, is substantial equivalence to predicate devices in terms of safety and effectiveness. For mechanical performance, this translates to demonstrating that its pullout strength is comparable to established devices like the Mitek anchors. The study performed to meet this criterion was "Pre-clinical testing in cadaver specimen."

Details that cannot be extracted from the provided 510(K) Summary:

2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "cadaver specimen" for the pre-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device performance test, not an image-based diagnostic test requiring expert ground truth for interpretation.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images. It's not applicable to a bone anchor.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This applies to AI algorithms.
7. The type of ground truth used: For pullout strength, the "ground truth" would be the measured force at which the anchor dislodges from the bone. This is a direct measurement, not an interpreted "ground truth" from experts or pathology.
8. The sample size for the training set: Not applicable. This device does not use machine learning with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is known from the document regarding the study:

• Study Type: Pre-clinical mechanical strength testing.
• Study Subject: Cadaver specimens.
• Measurement: Mean pullout strength.
• Comparison: Compared against Mitek Surgical Products GII Anchor and SuperAnchor.
• Conclusion: The LM Anchor's mean pullout strength was "substantially equivalent" to the Mitek anchors.

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Shoulder (bankart repair), Hand (ulnar or lateral collateral ligament reconstruction), Wrist (scapholunate ligament reconstruction), Foot (hallux valgus reconstruction), and Ankle (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.

This document is a 510(k) summary for a medical device (LM Anchor) and does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as typically found in submissions for AI/ML-driven imaging or diagnostic devices.

The provided text describes a bone anchor and its pre-clinical testing, which focuses on mechanical performance (pullout strength). It lacks any mention of:

• Acceptance criteria (quantitative metrics like sensitivity, specificity, AUC)
• Studies involving test sets, ground truth, experts, or comparative effectiveness with AI.
• Training sets or how their ground truth was established.
• Any AI or machine learning component.

The "Performance Data" section simply states: "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the Mitek Mini Anchor." This is a comparison of mechanical properties, not diagnostic or interpretive performance.

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