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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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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) submission for a medical device (Li Medical RotorBlade™) and an FDA clearance letter. It does not contain information about an AI/ML powered device, nor does it detail acceptance criteria and a study to prove the device meets these criteria in the context of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

The "Performance Data" section merely 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 anchors." This is a general statement of equivalence for the physical device, not an AI/ML performance metric.

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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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Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.

Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.

This 510(k) summary describes a device, the LM Anchor Products, not an AI/ML powered device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert qualifications, and MRMC studies, are not applicable.

However, I can extract the available performance information from the provided text for the medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a number of devices or subjects. The document mentions "cadaver specimen," implying human cadaveric tissue was used.
• Data Provenance: "Pre-clinical testing in cadaver specimen." This indicates a laboratory study using cadavers, not live human subjects. The country of origin is not specified.

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 mechanical performance test, not a diagnostic or interpretative one that would require expert ground truth establishment in the traditional sense. The "ground truth" here is the measured pullout strength.

4. Adjudication method for the test set

Not applicable. This is a direct measurement of pullout strength. No adjudication method typically applies to such biomechanical testing.

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

Not applicable. This is a non-AI mechanical device.

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

Not applicable. This is a non-AI mechanical device. The test measures the device's inherent mechanical property.

7. The type of ground truth used

The "ground truth" in this context is the measured pullout strength of both the LM Anchor Products and the predicate Mitek anchors, obtained through pre-clinical cadaveric testing.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

Not applicable. There is no training set. The "ground truth" (measured pullout strength) for the performance evaluation was established through direct experimental measurement on cadaveric specimens.

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UltraFix RC: Shoulder (rotator cuff repair)
UltraFix Mini: 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)
UltraFix: 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) or titanium (6A1-4V ELI), the LM Anchor Products are 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 text describes a 510(k) summary for the LM Anchor Products, focusing on their substantial equivalence to predicate devices, specifically Mitek Surgical Products GII QuickAnchor. However, the document does not contain the information needed to answer your specific questions about acceptance criteria and a study proving a device meets them.

The 510(k) summary mentions "Performance Data" with "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor Products were substantially equivalent to the mean pullout strength of the Mitek anchors." This statement is the closest to addressing performance, but it lacks the detailed information you requested.

Here's why I cannot provide the requested information based on the input:

• Acceptance Criteria: The document does not explicitly state any numerical or qualitative acceptance criteria for the LM Anchor Products' performance. It only states that their pullout strength was "substantially equivalent" to the predicate device.
• Reported Device Performance: While it mentions "mean pullout strength," it doesn't provide the actual numerical values for either the LM Anchor Products or the Mitek anchors.
• Sample Size (Test Set) and Data Provenance: The document states "cadaver specimen" but does not specify the number of specimens (sample size) or any details about their origin (e.g., country of origin). It is implicitly retrospective as it's pre-clinical testing.
• Number of Experts and Qualifications: This information is entirely absent. There's no mention of experts establishing ground truth for the pullout strength measurements.
• Adjudication Method: Not applicable or mentioned as there's no expert-based evaluation or scoring.
• MRMC Comparative Effectiveness Study: There is no indication of an MRMC study. This type of study is typically for evaluating a diagnostic AI device's impact on human readers, which is not relevant to a bone anchor's pullout strength.
• Standalone Performance: The pre-clinical testing mentioned is a standalone performance evaluation of the device itself (its mechanical properties), but the details are missing.
• Type of Ground Truth: For the pullout strength, the "ground truth" would be the measured physical force. However, this is not explicitly stated in the provided text.
• Sample Size for Training Set: There's no mention of a "training set" as this is not an AI/machine learning device.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided 510(k) summary is very high-level and only states that pre-clinical cadaver testing showed substantial equivalence in pullout strength to a predicate device. It does not provide the detailed scientific study design or results that your questions require.

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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, 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).

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 text describes a medical device, the "LM Anchor," and its performance compared to predicate devices. However, the information DOES NOT contain the level of detail required to answer your specific questions regarding acceptance criteria, study design, expert qualifications, and ground truth establishment for an AI/ML-based device.

The provided document is a 510(k) summary for a bone anchor, which outlines its design, intended use, and pre-clinical performance. It describes a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, the questions about AI/ML-specific study design elements (e.g., test set, training set, ground truth experts, adjudication methods, MRMC studies) are not applicable to this document.

Here's an attempt to answer the relevant questions based on the provided text, while highlighting the absence of AI/ML-specific information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The document mentions "cadaver specimen" but does not provide the number of specimens or anchors tested.
• Data Provenance: Not specified, but the data is from "pre-clinical testing in cadaver specimen," implying a controlled laboratory environment rather than patient data. No country of origin is mentioned. The study is prospective in nature for a pre-clinical assessment.

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)

• Not applicable. This relates to an AI/ML diagnostic device where experts establish ground truth for image or data interpretation. For a physical bone anchor, the "ground truth" is measured physical properties (e.g., pullout strength) determined by mechanical testing, not expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are used in AI/ML performance studies to resolve discrepancies in expert labeling or diagnoses. For mechanical testing of a physical device, the outcome is a measurable physical property, not subject to expert interpretation disputes in the same way.

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

• Not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document describes a physical surgical implant.

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

• Not applicable. This question pertains to the performance of an AI algorithm operating independently. The LM Anchor is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Mechanical Measurement: The "ground truth" for the LM Anchor's performance is its mean pullout strength as measured in pre-clinical cadaveric testing. This is a direct physical measurement.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model and therefore does not have a "training set."

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

In summary, the provided K960439 document is for a physical medical device (bone anchor) and does not contain the information requested for AI/ML device evaluation.

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