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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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