(37 days)
Apex® Pins are intended for use in conjunction with external fixators in children and adults. Specific indications include, but not limited to the following conditions: bone fracture fixation for open, closed and/or unstable fractures, osteotomies, arthrodeses, deformity correction including bone transport, revision procedures where other treatments or devices have been unsuccessful or bone reconstruction procedures. The pins will be available with and without hydroxylapatite (HA) coating.
This submission is a line extension to the Apex® Pin product line to include fixation pins coated with hydroxylapatite (HA) to improve purchase in osteoporotic bone and for use in long-term fixation to reduce the incidence of pin loosening by enhancing the fixation at the pin-bone interface. The Apex® Pins are external fixation pins used with external fixators for fracture fixation. They are intended to be used with the other components in Howmedica Osteonics' external fixation systems.
The provided text is a 510(k) Summary for the Apex® Pins with HA Coating. This summary describes a medical device and its intended use, but it does not contain the results of a study designed to demonstrate device performance against specific acceptance criteria in the way a clinical or in-vitro diagnostic study would.
Instead, this document focuses on demonstrating Substantial Equivalence to a predicate device based on design, materials, intended use, and operational principles. For a Class II device like this, the primary "study" referred to is mechanical testing and characterization of the HA coating to show equivalence in strength.
Therefore, many of the requested fields cannot be filled as they pertain to clinical performance studies, which are not detailed in this 510(k) summary. I will fill in the applicable information and note when the requested information is not available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | The Apex® Pins with HA coating must be substantially equivalent in strength to the predicate (uncoated Apex® Pins) and other commercially available uncoated and HA coated pins. (Implied: The HA coating should not compromise the pin's mechanical integrity). | "Testing was conducted to compare the subject HA coated pins to its uncoated predicate for mechanical strength... The results demonstrate that the subject pins are substantially equivalent in strength to the predicate pins with and without HA coating." (Specific values not provided in this summary). |
| HA Coating Characterization | The HA coating must be characterized to ensure its properties are consistent with its intended function (to improve purchase in osteoporotic bone and reduce pin loosening). | "Testing was conducted... to characterize the HA coating." (Specific characterization results or pre-defined acceptance metrics for the coating itself are not detailed in this summary). |
| Substantial Equivalence | The device must demonstrate substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and operational principles. | The FDA concluded, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. The summary only mentions "Testing was conducted."
- Data Provenance: Not specified. It can be inferred that the mechanical testing was likely conducted in a lab setting by the manufacturer (Howmedica Osteonics Corp.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The study mentioned (mechanical testing) does not involve expert review or "ground truth" in the clinical sense.
4. Adjudication method for the test set
- This information is not applicable and not provided. The study mentioned (mechanical testing) does not involve adjudication.
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
- No, a multi-reader multi-case comparative effectiveness study was not done. This device is a physical medical implant (an external fixation pin), not an AI-assisted diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used
- The concept of "ground truth" as typically used in diagnostic or AI studies (e.g., pathology, expert consensus, outcomes data) does not directly apply here. Instead, the "truth" for this device's performance relies on:
- Mechanical Test Standards and Measurements: Objective measurements of mechanical properties (e.g., strength, stiffness, fatigue resistance) according to recognized engineering standards.
- Material Characterization Techniques: Analytical methods to confirm the composition and properties of the HA coating.
- Comparison to Predicate: Performance is assessed against a legally marketed predicate device to demonstrate substantial equivalence, rather than an absolute clinical "ground truth."
8. The sample size for the training set
- This information is not applicable. Mechanical testing and material characterization studies do not typically involve a "training set" in the context of machine learning or statistical modeling.
9. How the ground truth for the training set was established
- This information is not applicable. (See #8).
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.