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MedicineLodge, Inc. (MLI) Modular Staples are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

The MLI Modular Staple is a three piece device consisting of a staple, a washer and a set screw that are designed to be used as an assembly unit. Each of the implant components are manufactured from Ti-6Al-4V ELI, per ASTM F-136 and are discussed in turn below.

The MedicineLodge, Inc. (MLI) Modular Staple is a medical device, and the provided text is a 510(k) Premarket Notification summary. This document is a pre-market submission to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device) and does not require extensive device testing based on its substantial equivalence.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense for a new AI/software medical device does not apply here. This document is essentially arguing that no new performance studies are necessary.

Here's an analysis based on the provided text, addressing your questions in the context of a 510(k) for a physical medical device relying on substantial equivalence:

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

This document does not present quantitative acceptance criteria or device performance data from a specific study designed to show the MLI Modular Staple meets those criteria. Instead, it argues for substantial equivalence to predicate devices based on design concepts, materials, manufacturing methods, and indications for use.

The closest to "reported device performance" are statements affirming that:

• "MLI Modular Staples are manufactured from proven materials"
• "equivalent in design to the selected predicate devices"
• "the staple design is virtually identical to standard bone staple design (per ASTM F-564)"
• "the set screw thread and hexagonal head drive design is in accordance with applicable ISO standards (ISO 5835, ISO 9268)"

The table (Table 1) provided in the document is a feature comparison to predicate devices, highlighting similarities and differences, rather than a performance comparison against specific acceptance criteria.

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

No test set or data provenance is mentioned because no new device performance testing was performed to support this 510(k) submission. The manufacturer explicitly states: "MedicineLodge, Inc. does not believe that device testing is necessary to demonstrate the substantial equivalence of the device."

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, as no new device performance testing or expert review of a test set was conducted for this 510(k). The ground truth for the claims of substantial equivalence relies on industry standards (ASTM, ISO) and the established safety and effectiveness of the predicate devices.

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

Not applicable, as no new device performance testing or adjudication of results was conducted for this 510(k).

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 document is for a physical orthopedic staple, not an AI or software device. Therefore, MRMC studies are irrelevant.

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

Not applicable. This is not an AI/algorithm device.

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

The "ground truth" in this context is based on:

• Established industry standards: ASTM F-136 (Ti-6Al-4V ELI material), ASTM F-564 (Bone Staples), ASTM F-116 (Hex driver), ISO 5835 and ISO 9268 (Bone Screws).
• Prior regulatory approvals: The existence and prior approval of predicate devices (Richards Fixation Staples and Linvatec Concept Staple Fixation System) which the MLI Modular Staple claims substantial equivalence to.
• General acceptance of materials and manufacturing methods: "proven implant materials and manufacturing methods."

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. No training set was used.

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

Not applicable, as this is not an AI/machine learning device. No training set was used.

Summary of the Document's Stance on "Device Testing":

The core of this 510(k) submission is the argument for substantial equivalence to existing legally marketed devices, thus circumventing the need for new clinical performance studies or extensive device testing at the time of submission. The manufacturer states:

• "MedicineLodge, Inc. does not believe that device testing is necessary to demonstrate the substantial equivalence of the device."
• They rely on "materials and vendor certifications, in-house standard operating procedures (SOP's), and applicable ASTM standards" during manufacturing.
• They do plan for "future device testing according to appropriate ASTM standards to quantitatively compare the performance of the MLI Modular Staple device to other commercially available bone staples in simulated testing," but this is future and not part of the current justification for the 510(k) clearance.

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The MedicineLodge, Inc. (MLI) - Cross Pin is used to secure soft tissue graft fixations during cruciate ligament reconstruction surgeries.

The MedicineLodge, Inc. (MLI) Cross Pin is a partially threaded metal fixation fastener used to attach soft tissue allografts or autografts to host bone.

This document describes a medical device, the MLI - Cross Pin, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence. The information provided is not from a study proving device meets acceptance criteria through clinical performance metrics, but rather a mechanical testing study aimed at demonstrating equivalence to a predicate device. Therefore, many of the requested fields cannot be directly populated as they relate to clinical efficacy and AI performance.

Here's an attempt to extract relevant information and note where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance thresholds for clinical outcomes (e.g., accuracy, sensitivity, specificity). Instead, the criterion for the mechanical testing was "no significant differences (p > 0.05)" in load to failure when compared to the predicate device.

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

• Sample Size for Mechanical Testing: Not explicitly stated. The document mentions "bending property studies on the subject and predicate device," implying multiple units were tested, but the exact number for each device type is not provided.
• Data Provenance: The tests were conducted by MedicineLodge, Inc. and are described as "non-in-vitro mode" which suggests lab-based mechanical testing, not human or animal data. The country of origin is MedicineLodge, Inc.'s location (Logan, UT, USA). The study is prospective in the sense that the tests were designed and executed to compare the devices.

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

Not applicable. This was a mechanical engineering test on physical devices, not a study requiring expert clinical interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable. This was a mechanical engineering test, not a study requiring clinical adjudication. The comparison was based on statistical analysis (Students t-test) of physical properties.

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 document describes a medical device (a fixation pin) and its mechanical properties. It does not involve AI or human readers.

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

Not applicable. This document describes a medical device (a fixation pin) and its mechanical properties. It does not involve AI algorithms.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured mechanical load to failure performance of the predicate device (DePuy Cross Pin) which the new device (MLI Cross Pin) aimed to be equivalent to.

8. The Sample Size for the Training Set

Not applicable. Mechanical testing does not typically involve "training sets" in the same way machine learning models do.

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

Not applicable. See point 8.

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The MedicineLodge, Inc. (MLI) - Set Screw is used to secure graft fixations during cruciate ligament, tendon or other soft tissue reconstruction surgeries.

The MedicineLodge, Inc. (MLI) Set Screw is a threaded, cannulated bone screw used to attach bone-tendon-bone allografts or autografts to host bone.

To begin, the design is similar in design to currently marketed endosteal set screws. The spiral threads are designed to firmly grasp the bone and graft during screw insertions, and the tapered proximal nose allows the set screw to hold the bone end of the graft upon insertion of the set screw. MLI Set Screws are designed to be manually inserted using a standard cannulated 3.5mm (cannulation of 0.096") hex driver, per ASTM F-116-85.

The MLI Set Screw will be available in 9mm and 11mm outer diameters, each offered in lengths of 20mm, 25mm, 30mm, 35mm and 40mm. The table below lists the various set screw combinations along with corresponding part numbers.

All MLI Set Screws are manufactured from Ti-6Al-4V ELI material (ASTM F-136) and are anodized per AMS 2488C for a smoother and more uniform surface finish. The anodized layer additionally provides an inert coating which helps to prevent galling and corrosion by providing a passive surface.

As mentioned previously, the MLI Set Screw possesses a central cannulation to allow the use of guide wires for accurate placement of the screw in the host bone. In application, the use of guide wires reduces the chances of tunnel screw divergence. All MLI Set Screws are designed for use with a 0.093 inch diameter guide wire, which is also provided by MedicineLodge, Inc.

The provided text describes a 510(k) submission for the MLI - Set Screw, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a traditional clinical study with defined acceptance criteria and statistical performance metrics typically seen in diagnostic or AI device submissions.

Therefore, many of the requested categories related to medical device performance metrics, such as sensitivity, specificity, MRMC studies, and ground truth establishment, are not applicable to this submission. The "acceptance criteria" here is primarily about demonstrating mechanical equivalence and performance comparable to the predicate device.

Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here is implicitly defined by the chosen statistical threshold for non-inferiority or equivalence in mechanical testing. The goal was to show that the MLI Set Screw's fixation strength was not statistically different from the predicate device.

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

• Sample Size: Not explicitly stated. The text mentions "fresh frozen porcine knee specimens" and "the test results... were compared," implying multiple specimens were used, but the exact number for statistical analysis is not provided.
• Data Provenance:
  • Country of origin: Not explicitly stated, but the testing was conducted by "MedicineLodge, Inc." (located in Logan, UT, USA).
  • Retrospective or Prospective: Not explicitly stated, but the description of the testing procedure ("The fixation strength testing was conducted on fresh frozen porcine knee specimens") suggests a prospective, experimental study design on biological models.

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

• Not Applicable. For a mechanical device like a set screw, "ground truth" typically refers to objective physical measurements rather than expert interpretations. The "truth" for this test was the measured fixation strength.

4. Adjudication Method for the Test Set

• Not Applicable. This concept is relevant for studies involving human interpretation or classification, not for direct mechanical 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

• No. This is not an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant.

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

• Not Applicable. This is not an algorithmic or AI device.

7. The Type of Ground Truth Used

• Mechanical Fixation Strength Data. The "ground truth" for this study was the quantified "Fixation strength" measured in the pig model through tensile testing.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not a machine learning or AI device. The testing described is a direct mechanical comparison.

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

• Not Applicable. See point 8.

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MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

The MLI Soft Tissue Screw and Washer System is an assembly unit consisting of MLI Soft Tissue Anchoring Screws and MLI Washers. The screws are provided in standard sizes (4.5 mm Cortical and 6.5 mm Cancellous) and conform to ISO 5835. They are self-tapping and inserted manually with a 3.5 mm hex driver. The washers are universally compatible with both screw sizes and come in three design configurations (Round, Triangular, Oval) with spikes on the distal side to penetrate bone and anchor the graft.

This is a premarket notification for a medical device (MLI Soft Tissue Screw and Washer System), not an AI/ML-powered device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the MLI Soft Tissue Screw and Washer System to predicate devices through mechanical testing. Here's a breakdown of the relevant information provided:

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

The document does not explicitly state numerical "acceptance criteria" for the MLI device. Instead, it aims to demonstrate substantial equivalence by showing that the MLI screw/washer constructs performed "as well or better than" the predicate screw/washer construct in yield load tests.

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

• Sample size: Not explicitly stated. The document mentions "a variety of screw/washer configurations" (four specific tests are listed) and compares them to "the currently marketed screw/washer construct." It does not specify the number of individual tests or samples conducted for each configuration.
• Data provenance: The testing was conducted by MedicineLodge, Inc. (manufacturer). The data is from prospective in-house mechanical testing. The "country of origin" is not specified but is implied to be within the US, given the FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. Ground truth, in the context of this document, refers to the physical measurement of mechanical properties (yield load and mode of failure) from the testing. These are objective measurements, not subjective evaluations requiring expert consensus for ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods are typically used for subjective assessments where there might be disagreement among reviewers, which is not the case for mechanical testing results.

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:

This information is not applicable. This is a non-AI/ML device.

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

This information is not applicable. This is a non-AI/ML device.

7. The type of ground truth used:

The ground truth used was mechanical testing results and observed modes of failure.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/ML device. The testing was conducted to demonstrate the performance and substantial equivalence of the physical device.

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

This information is not applicable. There is no "training set." The ground truth for the performance evaluation was established through controlled mechanical testing as described in the "DEVICE TESTING" section.

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The EXPANDED BODY suture is indicated for use in soft-tissue approximation and/or ligation in rotator cuff repair procedures.

The EXPANDED BODY suture is a braided, nonabsorbable, sterile, surgical suture composed of Poly(ethylene terapthalate) intended for use in rotator cuff soft-tissue repair procedures. This device is prepared from fibers of high molecular weight, fong-chain, linear polyesters having recurrent aromatic rings as an integral component.

The EXPANDED BODY suture is identical to currently marketed polyester sutures within this device class with the exception of the following:

1. a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
2. a new design which incorporates an expanded midsection equidistant from both ends of the suture possessing a larger outer diameter (two to four times) than the standard USP size.

The outer diameter of the expanded midsection thus has a cross-sectional area equal to or greater than the cross-sectional area of the needle or drill used to create the hole in the tissue. This ensures that the expanded midsection firmly engages the hole created by the drill or needle in the tissue.

Acceptance Criteria and Device Performance Study for EXPANDED BODY Suture

This document describes the acceptance criteria and the study conducted to demonstrate that the EXPANDED BODY Suture meets these criteria, as detailed in the provided 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For USP Compliance Testing (USP #871 and #881): A representative USP #5 EXPANDED BODY suture was used.
  • For Comparative Testing (pull-out strength): A representative USP #5 EXPANDED BODY design configuration was used, compared against a USP #5 TI•CRON nonabsorbable, polyester suture.
• Data Provenance: The studies were conducted by MedicineLodge, Inc. and are described as internal testing to verify conformance and comparative performance. This indicates a prospective nature, with data generated specifically for this submission. The country of origin of the data is not explicitly stated but can be inferred as the United States, given the manufacturer's location and FDA submission.

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

This submission does not rely on expert consensus or human interpretation for its performance evaluation. The "ground truth" for the test set is based on established, quantitative engineering and material standards, specifically the United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Suture and direct comparative physical testing against a predicate device. Therefore, no human experts were explicitly used to establish a subjective "ground truth" for the performance tests described.

4. Adjudication Method

Not applicable. The tests performed are objective, quantitative physical tests comparing against specified standards (USP) or direct comparison in a simulated environment, not clinical studies requiring adjudication of outcomes or interpretations.

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

No. A MRMC comparative effectiveness study was not performed. This device is a surgical suture, and its performance is evaluated through biomechanical and material property testing, not through human interpretation of images or clinical data where MRMC studies would be relevant.

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

This question is not applicable to the device under review. The EXPANDED BODY Suture is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here. All performance testing described is for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" used for testing the EXPANDED BODY Suture is based on:

• Established Industry Standards: Specifically, the United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Suture for tests like suture needle attachment and tensile strength.
• Comparative Performance to a Predicate Device: For pull-out strength, the "ground truth" for comparison was the performance of a legally marketed predicate device (TI•CRON) under identical simulated conditions.
• Material Science and Biocompatibility Data: The material composition (poly(ethylene terephthalate), color additives, stainless steel) is accepted as "ground truth" based on prior FDA approvals and established biocompatibility for predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device. The concepts of "training set" and "validation set" are relevant to machine learning or AI algorithm development, which is not applicable here. The device's design and manufacturing processes are based on established engineering principles and material science, not statistical training from a data set.

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

Not applicable, as there is no "training set" for a physical medical device of this nature.

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