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The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

The provided text describes the 510(k) summary for the Apex Kirschner Wires and Steinmann Pins. It does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in performance testing sections for AI/ML-driven devices. Instead, it focuses on substantial equivalence to predicate devices based on design and materials.

However, I can extract the relevant information that is present and explain where the requested details are absent.

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

   This information is not provided in the document. The submission is a 510(k) for orthopedic fixation devices (Kirschner Wires and Steinmann Pins), which typically rely on material properties, mechanical strength, and biocompatibility rather than "performance" in the sense of an algorithm's output metrics like sensitivity or specificity.
   The document states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This implies that the 'acceptance criteria' are implicitly met if these characteristics are equivalent to legally marketed predicate devices, which are presumed safe and effective.

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

   This information is not applicable/provided for this type of device submission. There is no 'test set' in the context of an algorithm or diagnostic device. The evaluation is based on engineering specifications and comparison to predicate devices, not data from a clinical trial or dataset.

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)

   This information is not applicable/provided. There is no ground truth established by experts for a test set, as this is a medical device (orthopedic pins) and not a diagnostic or AI-based product.

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

   This information is not applicable/provided. No adjudication method for a test set is mentioned because there is no such test set.

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/provided. An MRMC study is relevant for AI-assisted diagnostic devices. This submission concerns orthopedic hardware, not an AI system.

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

   This information is not applicable/provided. This device is a physical medical implant, not an algorithm.

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

   This information is not applicable/provided. Ground truth, as defined for algorithm performance, is not relevant here. The "truth" for this device lies in its material properties, manufacturing quality, and successful physical fixation as per its intended use, established through engineering standards and comparison to predicate devices.

8. The sample size for the training set

   This information is not applicable/provided. There is no 'training set' for this physical medical device.

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

   This information is not applicable/provided. There is no ground truth or training set for this device.

Summary of available information regarding the "study" proving device meets "acceptance criteria":

Based on the provided document, the "study" demonstrating the device meets "acceptance criteria" is a substantive equivalence comparison with legally marketed predicate devices.

• Study Design: A comparison of physical dimensions, materials, and technological characteristics of the Apex Kirschner Wires and Steinmann Pins to identified predicate devices:

  • Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215)
  • DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385)
  • OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555)
  • Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912)

• Acceptance Criteria (Implied): The device is considered to meet acceptance criteria if its physical dimensions, materials, and technological characteristics are "similar" or equivalent to the identified predicate devices, thereby establishing substantial equivalence in terms of safety and effectiveness for its intended use.

• Reported Device Performance: The document explicitly states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This statement serves as the 'reported performance' for the 510(k) process, indicating that the device design and materials are comparable to existing, approved devices.

• Data Provenance/Sample Size: Not applicable in the context of an AI/ML study. The 'data' consists of the specifications and characteristics of the Apex device and the predicate devices.

The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets regulatory requirements based on the comparative assessment.

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The Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.

Mahe Fixation Plate and Screw System consists of various shape and sizes plates featuring compression and locking or non-locking holes, fullthreaded-cortical, short threaded-cancellous, locking or non-locking, cannulated, self-tapping or non-self-tapping screws, compression and dynamic screws, implantable K-wires, pins, washers, and appropriate instrumentation. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The plates and screws are fabricated from stainless steel and titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in following models available: Tubular Plates, Reconstruction Plates, Cloverleaf Plates, Calcaneus Plates, Anatomical Plates, Clavicula Hook Plates, Small Fragment, Locking Plates, and DHSP/DCSP Screw Plates. The thickness of the plates varies from 1.2mm to 10mm; the length varies from 26mm to 317mm; and the number of the holes varies from 2 to 22. The screw implants are in three different diameter sizes (2.7mm, 3.5mm, and 4.0mm) and the K-wire implants are in various lengths (from 70mm to 310mm) and diameter sizes (from 0.8 to 3mm) available. The system is sold non-sterile, the products have to be sterilized prior to use.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance for the non-clinical performance data. It mentions that "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures," suggesting real-world data from Europe, but this is not a formal "test set" in the context of a controlled study.

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

This information is not provided in the document. The data presented is primarily non-clinical "performance data" such as testing against industry standards, biocompatibility, and mechanical properties, rather than data requiring expert-established ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical performance data (e.g., mechanical testing against standards).

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

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data and a comparison of technological characteristics to predicate devices.

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

This is not applicable as the device is a medical implant (plates, screws, and pins), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" is established by:

• Industry Standards: Compliance with established international and national standards (ISO 5838, ASTM F366-04, ASTM F0543-07, ASTM F 382-99).
• Predicate Device Performance: Direct comparison of functional and mechanical properties against legally marketed predicate devices.
• Biocompatibility Testing: Results of established biocompatibility tests.

There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus) in the context of a clinical study for this 510(k) summary.

8. The Sample Size for the Training Set

This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.

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

This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.

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