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Shoulder - rotator cuff repair

Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.

The provided text describes a 510(k) summary for the Li Medical RotorBlade™ suture anchor and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through extensive clinical trials with specific acceptance criteria in the way a pharmaceutical or novel medical device might.

Therefore, the information requested for a detailed study description and acceptance criteria is not fully available or applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria in a quantitative table. The primary "criterion" for this 510(k) was to demonstrate substantial equivalence to the predicate device (Li Medical RotorBlade™ K983435 & K992938).

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

• The text mentions "Pre-clinical testing showed that the mean pullout strength of the LM Anchor was substantially equivalent..."
• Sample Size: Not specified.
• Data Provenance: Not specified, but "pre-clinical testing" typically refers to in vitro or ex vivo studies, not human clinical data. Given the device type, it's highly likely this was mechanical testing.

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

• This type of information (experts establishing ground truth) is not applicable to the pre-clinical mechanical testing described for this device. Ground truth for pullout strength would be objective measurements from testing equipment, not expert consensus.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers or experts, which is not relevant to mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is designed to assess the diagnostic performance of a device with human readers, often for image interpretation. This device is a surgical implant, and the testing described is mechanical, not diagnostic.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical surgical anchor, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI is not relevant.

7. The Type of Ground Truth Used:

• For the "pre-clinical testing" mentioned (specifically pullout strength), the ground truth would be objective engineering measurements (e.g., force in Newtons or pounds-force) obtained directly from a testing machine (e.g., a universal testing machine).

8. The Sample Size for the Training Set:

• Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device underwent pre-clinical mechanical testing, not algorithm development.

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

• Not applicable. As above, no training set for an algorithm was used.

In summary: This 510(k) submission relies on demonstrating substantial equivalence primarily through pre-clinical mechanical testing (specifically pullout strength) and by showing identical design, material, and intended use as a previously cleared predicate device, with only the sterilization method changing. The regulatory pathway of 510(k) premarket notification does not typically require the extensive clinical trials or expert consensus-based studies associated with establishing acceptance criteria and ground truth in the way described in your template.

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Shoulder - rotator cuff repair
Shoulder: rotator cuff repair

Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LM Anchor, formatted as requested:

Acceptance Criteria and Study for LM Anchor

The provided 510(k) summary for the Li Medical RotorBlade™ (LM Anchor) focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel safety and effectiveness through a rigorous performance study with predefined acceptance criteria. The primary evidence presented is preclinical testing showing substantial equivalence in pullout strength.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The summary only mentions "Pre-clinical testing."
• Data Provenance: Not explicitly stated. However, "Pre-clinical testing" typically implies laboratory or ex-vivo testing rather than in-vivo human data. It's likely conducted in a controlled lab setting, not geographically specific patient data. It is retrospective in the sense that it aims to compare against an already marketed predicate, but the testing itself would have been newly performed.

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

• This information is not applicable as the study described is a pre-clinical, mechanical comparison of pullout strength. Ground truth in this context would likely be defined by physical measurements and engineering standards, not expert medical opinion.

4. Adjudication Method for the Test Set

• This information is not applicable as the study described is a pre-clinical, mechanical comparison. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints. Physical measurements for pullout strength would be objective and not require adjudication by human experts in the medical sense.

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

• No, an MRMC comparative effectiveness study was not done. This device is a mechanical surgical anchor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, questions regarding AI assistance and human reader improvement are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this is not an AI algorithm. It is a physical medical device (suture anchor). Therefore, the concept of standalone algorithm performance is not applicable. The performance evaluated was the mechanical pullout strength of the physical device itself.

7. The Type of Ground Truth Used

• The "ground truth" for the pre-clinical pullout strength testing would have been objective physical measurement of the force required to pull the anchor out of the test substrate (likely bone or a bone substitute). This is a direct physical property measurement, not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• This information is not applicable. This is a physical device subject to mechanical testing, not a machine learning model that requires a training set.

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

• This information is not applicable as there is no training set for a physical device.

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