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510(k) Data Aggregation
(142 days)
Metric Medical Devices, Inc.
The LINK™ External Fixator is indicated for 1) hand and foot bone fragment and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude LINK™ Bone Pin placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
The LINK™ External Fixator is a single use External Fixator consisting of a stainless steel flat spring formed into a box shape so that when released it applies forces and moments to Bone Pins, K-wires or Steinmann pins embedded in bone to actively pull together and compress or distract bone.
In clinical use the LINK™ External Fixator is held with its holes aligned using surqical needle drivers while wires or pins are advanced through the LINK™ External Fixator, skin and into bone. Once pins are placed the needle drivers are released, the LINK™ External Fixator bridge shortens to apply forces and the LINK™'s side elements swing outward to create moments on the wires or pins.
The LINK™ External Fixator uses spring heat treated 17-7 stainless steel which is uniquely formed from a flat plate to create a shape changing spring. The Bone Pins in this kit are formed with 316 Stainless Steel. The LINK™ External Fixator has a separate removable silicon elastomer cover to protect the LINK™ External Fixator and the patient from the pin ends. Only the Bone Pins are in contact with the patient while the LINK™ External Fixator and its cover are external to the body and not intended for patient contact.
The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "LINK™ External Fixator." This document details the device, its intended use, comparison to a predicate device, and the basis for its substantial equivalence determination.
However, the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document.
The text focuses on mechanical bench testing to demonstrate the device's physical performance characteristics, such as:
- Construct pull out
- 4-point bending for bone pin
- 4-point bending for fixator construct in a bone analog
- Static ultimate strength in tension bending
- Fatigue in tension bending
- LINK™ force applied to bone
It explicitly states: "Performance Data: Bench testing included construct pull out, 4-point bending for bone pin, 4-point bending for fixator construct in a bone analog, static ultimate strength in tension bending, fatigue in tension bending and the LINK™ force applied to bone."
This is a physical medical device, not an AI or software-based diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, clinical accuracy, MRMC studies, human reader improvement with AI assistance, independent algorithm performance) are not applicable here.
In summary, based only on the provided text, I cannot fill out the requested table or answer the questions related to clinical study performance, AI component validation, or expert-based ground truth because the document describes a traditional mechanical medical device cleared based on bench testing and comparison to a predicate device, not clinical validation of diagnostic performance.
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(120 days)
METRIC MEDICAL DEVICES, INC.
The IFS Fixation Scaffold is indicated for small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes.
The IFS is a hollow fenestrated cylinder fabricated from nitinol with a section that increases the implants diameter to lock into the medullary compartment of bone while shortening its length. The nitinol's transition temperatures are set so that the material is in the austenitic state when released at room temperature. Features on the cylinder's surface, such as bulges and prongs, lock into bone.
The IFS is pre-loaded onto an insertion instrument and held elongated in position by a lock plate. During insertion, the IFS is released by turning a knob on its instrument while the lock plate both releases the IFS and limits the depth of implant insertion.
The IFS implants range in diameter from 2.5 to 4.5 mm and up to 9.3 mm when expanded and range in length from 21 to 27 mm depending on size and extent of contraction.
The provided document is a 510(k) premarket notification for the Intramedullary Fixation Scaffold (IFS) System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be done for a software or AI/ML-driven device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not relevant or available in this type of submission.
However, I can extract the relevant performance data that serves as the "acceptance criteria" and the "study" demonstrating the device meets these in the context of a 510(k) submission, which focuses on comparison to predicate devices.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
In a 510(k), "acceptance criteria" are often implicitly defined by the performance of the predicate device, with the new device needing to perform "equivalently or better."
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (IFS Fixation Scaffold) |
|---|---|
| Corrosion Susceptibility (equivalent or better than predicate per ASTM F2129) | "The corrosion behavior of the IFS was equivalent or better than the predicate device to which it was compared and presented high corrosion breakdown potentials for all IFS devices tested." |
| Contraction Force (equivalent to or less than predicate bone staple implants K123363 9x9 mm and 11x10 mm) | "Contraction tests showed that the IFS contraction force causing bone segments to be put into compression was equivalent to or less than the 9x9 mm and 11x10 mm bone staple implants of K123363." |
| Expansion Force (equivalent or superior to predicate K133520) | "...the expansion force causing retention in the medullary canal was equivalent or superior to the K133520 predicate device." |
| Ultimate Strength in Bending (equivalent or superior to predicates K133520 and K863734) | "Ultimate strength in bending was measured for the IFS, K133520 and K863734 and the IFS was found equivalent or superior in strength to the predicate devices tested." |
| Bone Fixation Strength (equivalent or superior to predicates K133520 and K863734) | "Bone fixation strength was measured for the IFS, K133520 and K863734 and the IFS was found equivalent or superior to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices or "test set" size. The document refers to "all IFS devices tested" for corrosion and "the IFS" (implying a set of IFS devices) for mechanical tests. For the predicates, it refers to specific models (e.g., "9x9 mm and 11x10 mm bone staple implants of K123363"). The exact number of units tested for each metric is not disclosed.
- Data Provenance: The studies are described as "Corrosion testing per ASTM F2129" and various mechanical tests conducted on the IFS and predicate devices. No information on country of origin of data or retrospective/prospective nature is provided, as these are in vitro engineering tests of the device itself, not clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This relates to clinical data interpretation or ground truth establishment for AI/ML algorithms, which is not the subject of this 510(k) for a physical medical device. The "ground truth" here is the physical measurement of the device's mechanical and material properties.
4. Adjudication method for the test set
- Not applicable. This is for clinical data review or AI/ML ground truth, not for in vitro material and mechanical testing. The results are from direct physical measurements.
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 device is a physical scaffold, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical scaffold, not an AI/ML algorithm.
7. The type of ground truth used
- For the performance data mentioned (corrosion, contraction/expansion force, ultimate strength, bone fixation strength), the "ground truth" is established through objective, standardized engineering and material science measurements according to recognized ASTM standards (e.g., ASTM F2129 for corrosion) or similar biomechanical testing protocols. These are direct physical properties of the device and its interaction with simulated bone.
8. The sample size for the training set
- Not applicable. This refers to AI/ML algorithms. The IFS System is a physical device.
9. How the ground truth for the training set was established
- Not applicable. This refers to AI/ML algorithms.
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(63 days)
METRIC MEDICAL DEVICES, INC.
The Super™ Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
The Super Staple™ is a two leg U-shaped staples fabricated from nitinol alloy with an S-shaped bridge design. These U-shaped compressive staples range in width from 9 to 30 millimeters. Staple prong length ranges from 7 to 30 mm and staples have prongs of equal and unequal length.
This is a summary of the performance data for the Super Staple™ Classic, based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Corrosion Testing (ASTM F2129) | Acceptable corrosion behavior, substantially equivalent to predicate devices. | The corrosion behavior of the Super Staple™ was acceptable for all samples tested and substantially equivalent to the predicate devices. |
| Staple Compression | Substantially equivalent compression force compared to predicate staples. | Compression tests showed that the Super Staple™ has a substantially equivalent compression force when compared to the predicate staples tested. |
| Pull-out | Substantially equivalent pull-out force compared to predicate staples. | Pull-out tests showed that the Super Staple™ had a substantially equivalent pull-out force when compared to the predicate staples tested. In this test, the performance of the Super Staple™ meets the performance of the predicate devices. |
| Ultimate Strength (Failure Load, Stiffness, Deflection) | Substantially equivalent to the predicate device. | Strength of the Super Staple™ in failure load, stiffness, and deflection was measured and found substantially equivalent to the predicate device tested. |
| Fatigue Strength (S-N curves) | Substantially equivalent or better load at run-out compared to the predicate device. | Fatigue testing S-N curves and their characteristic equations showed that the Super Staple™ withstands substantially equivalent load at run-out when compared to the tested predicate device. Thus, the fatigue performance of the Super Staple™ is substantially equivalent or better than the predicate devices. |
2. Sample Size and Data Provenance
The document does not specify the exact sample sizes (number of staples) used for each individual test. It refers to "all samples tested" for corrosion and "predicate staples tested" for other mechanical tests. The data provenance is not explicitly mentioned (e.g., country of origin). Based on the nature of the tests (mechanical and corrosion), this would be laboratory-generated data, not human patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a mechanical implant, and its performance evaluation relies on objective physical and mechanical testing, not a ground truth established by human experts.
4. Adjudication Method for the Test Set
Not applicable. The performance evaluation is based on objective measurements from physical tests, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a medical device (surgical staple) and not an AI/imaging diagnostic device. Therefore, a multi-reader multi-case comparative effectiveness study with human readers assisting with AI is not relevant.
6. Standalone (Algorithm Only) Performance Study
No. This is a mechanical medical device, not an algorithm or software. Therefore, a standalone performance study in the context of AI algorithms is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective physical and mechanical measurements against defined engineering standards and comparison to legally marketed predicate devices. This includes:
- Corrosion resistance specified by ASTM F2129.
- Measured compression force.
- Measured pull-out force.
- Measured ultimate strength parameters (failure load, stiffness, deflection).
- Measured fatigue strength (S-N curves and load at run-out).
8. Sample Size for the Training Set
Not applicable. This device is a mechanical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical device.
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