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Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions; and osteotomies of the femur

The subject device includes a total of 14 bones plates for internal fixation of the distal lateral femur. All LOQTEQ Distal Lateral Femur Plates 4.5 are available non-sterile.

The subject device is provided in anatomic designs in overall lengths of 153 mm, 207 mm, 243 mm, 279 mm, 314 mm, 350 mm, and 386 mm, for the left and right distal femur. The plates are provided with 4, 7, 9, 11, 13, 15, and 17 screw holes, respectively, in the shaft of the plate. Lengths of 153 mm, 207 mm, 279 mm, 279 mm, and 314 mm are identical to the plates previously cleared in K121494. Subject device plates in lengths of 350 mm and 386 mm are identical to the plates previously cleared in K121494, except for the length.

The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121494 and K072411 and K-wires, previously cleared in K131459, presently marketed as part of the LOQTEQ Distal Lateral Femur Plate 4.5 System. The compatible screws are 4.5 mm in diameter. The subject device plates also are compatible with 2.0 mm diameter aap K-Wires.

The provided document is a 510(k) summary for the LOQTEQ® Distal Lateral Femur Plate 4.5 System, a Class II medical device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. This document does NOT describe a study involving an AI/software device that requires intricate acceptance criteria related to accuracy, sensitivity, or specificity, nor does it detail a multi-reader multi-case (MRMC) study or complex ground truth establishment processes typical for such devices.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/software performance study for which your template is designed. The document explicitly states: "Clinical data were not submitted in this premarket notification." and "Any differences in the technological characteristics among the subject and predicate devices do not raise different questions of safety and effectiveness."

Instead, the "performance data" section refers to:

• Biocompatibility referenced from K121494 and K153034.
• Validation of the recommended end-user moist heat sterilization cycle.
• Mechanical testing referenced from K121494.

The "acceptance criteria" here would relate to these engineering and material standards, not to diagnostic or prognostic performance metrics of an AI.

To answer your prompt truthfully based on the provided text, I must state that the information you requested regarding acceptance criteria and studies proving the device meets them (in the context of AI/software performance) is not present in this 510(k) summary. The document is for a traditional medical device (a bone plate system) and details its substantial equivalence based on material, design, and manufacturing similarities to existing devices, supported by non-clinical engineering tests, not AI performance studies.

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The system LOQTEQ® VA Foot Plates 2.5 is intended for use in stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of bones of the feet. Implants are intended for single use on adult human bone.

LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1:

• plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure)

LOQTEQ® VA L-Fusion Plate 2.5:

• LisFranc Arthrodesis and/or Stabilization
• 2nd Tarsometatarsal (TMT) Fusions

LOQTEQ® VA Straight Fusion Plate 2.5:

• LisFranc Arthrodesis and/or Stabilization
• 3rd Tarsometatarsal (TMT) Fusions

LOQTEQ® VA Osteotomy Plate 2.5:
First metatarsal osteotomies for hallux valgus correction including:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Proximal Chevron osteotomy

LOQTEQ® VA MTP Fusion Plate 2.5:
Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Primary MTP Fusion due to hallux rigidus and/or hallux valgus

LOQTEQ® VA MTP Revision Plate 2.5:
Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant

LOQTEQ® VA Metatarsal Straight Plate 2.5/LOQTEQ® VA Metatarsal L-Plate 2.5/LOQTEQ® VA Metatarsal T-Plate 2.5

• Metatarsal or metacarpal fractures and osteotomies
• Phalanges fractures and osteotomies

LOQTEQ® VA X-Plate 2.5:

• fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including the foot

LOQTEQ® VA Hook Plate 2.5:

• internal bone fixation for bone fractures of the 5th metatarsal of the foot

LOQTEQ® VA Plantar Fusion Plate 3.5, TMT 1:

• plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure)

The LOQTEQ® VA Foot Plates 2.5 includes invasive products for the implantation on bones of the foot. The implants consist of a titanium-aluminum-vanadium alloy (TiAl6V4) and have different kind of holes that can be used for fixation with polyaxial angular stable locking screws or standard cortical screws. The DC-hole can be used for dynamic compression with a lag screw. As the case may be, the plates can be placed with a K-wire to fix the plate temporarily before the screws are tightened.

The provided text describes a 510(k) premarket notification for the LOQTEQ® VA Foot Plates 2.5. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against specific metrics. Therefore, the concept of "acceptance criteria" as applied to novel performance outcomes is not directly applicable in the same way as it would be for, say, an AI-powered diagnostic device.

Instead, the "acceptance criteria" here implicitly refer to the demonstration that the subject device performs comparably to its predicate devices in terms of mechanical safety and functionality. The study that proves the device meets these comparative acceptance criteria is primarily bench testing.

Here's the breakdown of the information requested, adapted to the context of a 510(k) submission for a metallic bone fixation appliance:

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 regarding the number of plates or screws tested. The text refers to "tests" and "test results" but does not provide specific quantities for the bench testing.
• Data Provenance: The testing was conducted by an "independent, certified and accredited test laboratory (MDD 93/42/EEC, ISO 17025): Questmed GmbH." This suggests the testing was performed in a controlled, prospective manner by a third-party laboratory. The location of Questmed GmbH is not provided in the document, but it is typically a European certification body.

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

This information is not applicable to this type of device submission. Bench testing for mechanical properties does not involve human experts establishing a "ground truth" in the same way an AI diagnostic device would require radiological expert consensus. The "ground truth" here is the physical measurement of mechanical properties against established standards and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical bench testing does not involve adjudication of results by multiple experts. The results are quantitative measurements against predefined protocols (e.g., ASTM F 382-14 for plates, ASTM F543-13 for screws).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices to compare human performance with and without AI. The LOQTEQ® VA Foot Plates 2.5 are physical metallic bone fixation appliances, not an AI or diagnostic device.

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

No, a standalone performance evaluation in the context of AI algorithms was not done. This device is a physical implant. The "standalone" performance here refers to the device's mechanical properties tested independently.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its 510(k) submission, is established through:

• Mechanical Performance Standards: Adherence to recognized industry standards such as ASTM F 382-14 for plates and ASTM F543-13 for screws.
• Predicate Device Performance: Direct comparison of the subject device's mechanical test results against "well clinically proven and equivalent benchmark products" (predicate devices). The performance of these predicate devices acts as the "ground truth" for what constitutes acceptable mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "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 this physical device.

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