Search Results

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 document describes a 510(k) submission for Apex Kirschner Wires and Steinmann Pins, focusing on changing the offering from "sterile" to "non-sterile" with validated sterilization instructions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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

The document does not explicitly state the sample size used for the sterility validation study, nor does it specify the data provenance (country of origin, retrospective or prospective). It only mentions that "a sterility validation study was performed."

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 and not provided in the document. The device is a physical medical instrument (Kirschner Wires and Steinmann Pins), and its performance in this context relates to sterilization effectiveness, not diagnostic interpretation requiring expert medical review.

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

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective medical interpretations (e.g., image reading), which is not relevant for a sterility validation study of a medical device.

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

There was no MRMC comparative effectiveness study done. This type of study relates to diagnostic aids, particularly AI-assisted ones, which is not relevant for Kirschner Wires and Steinmann Pins.

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

This information is not applicable and not provided in the document. A standalone algorithm performance study is relevant for AI or diagnostic software, not for basic medical instruments like Kirschner Wires and Steinmann Pins.

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

The ground truth for the sterility validation study would be the absence of viable microorganisms after the sterilization process, meeting the defined Sterility Assurance Level (SAL) of 10^-6. This is established through microbiological testing.

8. The sample size for the training set

This information is not applicable and not provided in the document. The concept of a "training set" is relevant for machine learning or AI models, not for traditional medical device manufacturing and sterilization validation.

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

This information is not applicable and not provided in the document. As mentioned above, "training set" and its associated ground truth establishment are not relevant to this type of device and study.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that a sterility validation study was performed to support the change from "sterile" to "non-sterile" Kirschner Wires and Steinmann Pins. The acceptance criterion for this study was achieving a Sterility Assurance Level (SAL) of 10^-6 with the recommended sterilization instructions. The study successfully confirmed that this SAL was achieved.

The specific details of the sterility validation study, such as the protocol, the number of samples tested, or the methods used to determine the SAL, are not provided in this summary. However, the FDA's acceptance of the 510(k) submission indicates that the agency found the validation study results sufficient to demonstrate that the device, when sterilized according to instructions, meets the required sterility standards.

Ask a specific question about this device

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.

Ask a specific question about this device