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REPAIR/RECONSTRUCTION OF COLLATERAL LIGAMENTS, FLEXOR AND EXTENSION TENDONS AT THE PIP (PROXIMAL INTERPHALANGEAL), DIP (DISTAL INTERPHALANGEAL), AND MCP (METACARPAL INTERPHALANGEAL) JOINTS FOR ALL DIGITS

The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6AI 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal anchors. The Mitek Mini anchor design was first cleared to market by US FDA in K915089 and K930892. The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an Inserter.

The provided text describes the Mitek Micro Anchor, a medical device for fixing sutures to bone. The information about the study and acceptance criteria is extracted below:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly set by the performance of the predicate device (USP Class I suture) and relevant historical data for tissue failure. The Mitek Micro Anchor's performance is presented as exceeding these values.

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

The document refers to "pull tests from cadaveric and porcine locations."

• Sample Size: Not explicitly stated as a number of samples, but the four categories tested are "Cadaver Hand," "Cadaver Skull," "Pig Metacarpals," and "Suture w/Bone Tunnels."
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: These appear to be prospective, controlled mechanical tests.

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

• This was a non-clinical test (mechanical pull tests), not involving human diagnostic interpretation or clinical ground truth as typically understood in AI/medical imaging studies. Therefore, no experts were used to establish "ground truth" in this context. The "ground truth" here is the measured failure load.

4. Adjudication Method for the Test Set:

• Not applicable as this was a non-clinical, mechanical test, not an expert-driven adjudication process.

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

• No, an MRMC study was not performed. This device is a surgical implant, not a diagnostic imaging AI tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the performance presented in the table is a standalone mechanical performance of the device (pull-out strength) without human-in-the-loop interaction in the context of diagnostic interpretation.

7. Type of Ground Truth Used:

• The ground truth for the device's performance was empirically measured failure load (mechanical strength), reported in pounds (LBS). This is compared against the known strength of sutures and historical data on suture and tissue failure.

8. Sample Size for the Training Set:

• The document does not specify a training set. This is a characteristic of engineering/mechanical testing, not typical AI/machine learning development where a training set is used to "teach" an algorithm.

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

• Not applicable, as no training set for an algorithm is mentioned or implied. The device's design is described as "similar in design to the Mitek GII Mini Anchor," suggesting a design based on prior engineering principles and existing devices, rather than an iterative machine learning training process. The "design criteria" mentioned in the conclusion refer to engineering specifications.

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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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The device is used to anchor suture into bone . The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.

The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal Anchors. The Mitek Mini Anchor design was first cleared to market by US FDA in K915089 and K930892. The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an inserter.

The provided text is a summary of safety and effectiveness for a medical device (Mitek Micro Anchor) seeking 510(k) clearance from the FDA in 1996. It details the device's design, materials, intended use, and comparison to a predicate device (suture).

However, the document does NOT contain information regarding:

• Acceptance criteria for the device's performance in a study.
• A "study that proves the device meets the acceptance criteria" in the modern sense of a clinical trial or performance evaluation with statistical metrics.
• Sample sizes for test or training sets.
• Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a regulatory submission for a medical device that predates the common expectation of detailed efficacy studies with AI elements. It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and mechanical properties, not on performance against specific, quantifiable acceptance criteria established through a clinical study with detailed statistical analysis.

Therefore, I cannot fulfill your request for the specific information points because they are not present in the provided text. The document describes a device for physical fixation, not a diagnostic or AI-driven device that would typically involve the kind of performance metrics and study details you've requested.

The "comparison to predicate device" aspect mentions "It has greater strength than USP #4/0 suture," which is a claim of superior physical performance, but it doesn't specify how this was measured, the acceptance criteria for "greater strength," or the study details.

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The device is used to anchor suture into bone . The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the lateral canthoplasty and collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture. when used to approximate soft tissue to bone during a period of rehabilitation.

The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal anchors. The Mitek Mini anchor design was first cleared to market by US FDA in K915089 and K930892. The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an Inserter.

The provided text describes a medical device, the Mitek Micro Anchor, and its non-clinical and clinical testing for FDA 510(k) clearance. However, it does not describe an AI/ML powered device or a study involving an algorithm. Therefore, many of the requested categories in your prompt are not applicable to the given input.

I will provide the information that is available from the text, indicating where information is not present or not relevant to this type of device submission.

Here's the analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

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

The acceptance criteria are not explicitly stated in a quantitative manner as "If X, then Y." Instead, the submission implies acceptance by demonstrating superior strength compared to the predicate device (suture) and by referencing historical data for the identical surgical procedure in clinical tests. The "performance" is primarily shown through pull tests.

Note: The intent is to show that the Mitek Micro Anchor's pull strength in various tissues is significantly greater than the standard #4/0 suture's pull strength (2.64 lbs), thus demonstrating its effectiveness. The specific threshold for "acceptance" is not numerically defined beyond this comparative superiority.

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

• Non-Clinical (Pull Tests): Specific sample sizes for each pull test (cadaver hand, skull, pig metacarpals, suture w/ bone tunnels) are not explicitly stated. The "average failure load" suggests multiple tests were performed for each category, but the number of samples per average is missing.
• Clinical Tests: "clinical trials" are mentioned, conducted in accordance with IDE #G880026. The number of patients or procedures in these trials is not provided.
• Data Provenance: Not specified (country of origin). The clinical tests were likely prospective as they refer to "clinical trials." The non-clinical tests are laboratory-based.

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 device is a surgical implant (anchor), not an AI/ML diagnostic tool. Ground truth in the context of expert review for image interpretation or similar AI applications is not relevant here. The "ground truth" for non-clinical testing is the measured mechanical failure load, and for clinical testing, it's patient outcomes as assessed by the surgeons.

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

• Not Applicable. See point 3.

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 not an AI/ML device. No MRMC study was conducted.

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

• Not Applicable. This is not an AI/ML device.

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

• Non-Clinical: Mechanical failure loads measured directly.
• Clinical: "Safety and effectiveness was based upon the results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure." This implies a form of clinical outcomes data (e.g., success of reattachment, absence of complications) compared against historical benchmarks.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device. There is no "training set."

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

• Not Applicable. See point 8.

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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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