(84 days)
The 3.9mm pelvic screw is indicated for fracture fixation of the pelvis as well as for periacetabular osteotomies.
The Synthes 3.9 mm Pelvic Screw is a machined metallic screw with a hex drive head.
This submission (K013044) for the Synthes 3.9 mm Pelvic Screw does not contain a study demonstrating that the device meets specific acceptance criteria in the way a diagnostic AI/ML device would. Instead, this is a 510(k) premarket notification for a medical device (a bone screw), which focuses on demonstrating substantial equivalence to legally marketed predicate devices.
Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, ground truth establishment for AI, MRMC studies, etc.) are not applicable to this type of device submission.
Here's a breakdown of the relevant information provided in the document in response to your request, indicating where information is not applicable:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
| Acceptance Criteria (Implied by Substantial Equivalence Pathway) | Reported Device Performance (Synthes 3.9 mm Pelvic Screw) | Explanation/Context |
|---|---|---|
| Material Composition Must be biocompatible and suitable for implantation. | Stainless Steel | The device is made of stainless steel, a commonly used and accepted material for bone fixation devices. Substantial equivalence implies that this material is suitable given its use in predicate devices. |
| Mechanical Properties Must provide stable fixation for indicated uses. | "machined metallic screw with a hex drive head" | While specific mechanical properties (e.g., tensile strength, torsion resistance) are not explicitly detailed in this summary, the "substantial equivalence" claim means that the device's design and mechanical characteristics are comparable to legally marketed predicate devices, which are presumed to have acceptable performance for their intended use. |
| Indications for Use Must be safe and effective for its stated purpose. | Fracture fixation of the pelvis and periacetabular osteotomies. | The stated indications are for fracture fixation of the pelvis and periacetabular osteotomies. Substantial equivalence confirms that these indications are appropriate for a device of this type, aligning with the indications of predicate devices. The FDA's clearance implies they found the device safe and effective for these indications based on the comparison to predicates. |
| Device Design/Form Must be similar in design and principle of operation to predicate devices. | "manufactured in various lengths as threaded screws" | The device is described as a "machined metallic screw with a hex drive head." The submission states that "Documentation was provided which demonstrated the Synthes 3.9 mm Pelvic Screw to be substantially equivalent to other legally marketed devices," indicating design similarity. |
| Sterilization & Packaging (Not explicitly detailed in this summary but required for all implants) | (Not explicitly detailed) | Expected to be sterile and appropriately packaged for an implantable device, in line with predicate devices and general controls. |
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Sample size used for the test set and the data provenance: Not applicable. This is a medical device (bone screw) submission based on substantial equivalence, not a diagnostic AI/ML device requiring a test set of data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of medical device. "Ground truth" in the context of substantial equivalence for a bone screw refers implicitly to the established safety, effectiveness, and performance of legally marketed predicate devices, which have been proven through clinical use and regulatory review over time.
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Adjudication method for the test set: Not applicable for this type of medical device submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are typically for diagnostic imaging devices or software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implantable device, not an algorithm.
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The type of ground truth used: For this device, the "ground truth" for demonstrating substantial equivalence is based on the established safety and efficacy profiles of legally marketed predicate devices, which implies:
- Clinical history of similar devices.
- Performance standards met by similar devices.
- Regulatory acceptance of similar designs and materials.
- Bench testing (mechanical, material, biocompatibility) demonstrating comparability to predicates (though specific results are not in this summary).
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The sample size for the training set: Not applicable for this type of medical device.
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How the ground truth for the training set was established: Not applicable for this type of medical device.
Summary of the Study (Substantial Equivalence Demonstration):
The "study" referenced in this document is not a clinical trial or an AI/ML algorithm validation study. Instead, it is the submission of documentation to the FDA (510(k) premarket notification) demonstrating that the Synthes 3.9 mm Pelvic Screw is substantially equivalent to other legally marketed predicate devices.
The FDA's decision letter (K013044) states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...".
This means that Synthes (USA) provided data and analysis to convince the FDA that their new device is as safe and effective as existing devices on the market. This typically involves:
- Comparing the device's design, materials (Stainless Steel), and fundamental scientific technology to predicate devices.
- Comparing the intended use and indications (fracture fixation of the pelvis, periacetabular osteotomies) to predicate devices.
- Likely, performing bench testing (e.g., mechanical strength, fatigue, biocompatibility) to show equivalent performance to predicates, though these specific test results are not detailed in the provided summary.
- Addressing any differences and demonstrating they do not raise new questions of safety or effectiveness.
In summary, for a traditional medical device like a bone screw, "acceptance criteria" are generally met by demonstrating equivalence to a device that has already been accepted as safe and effective by the regulatory body. This is a different pathway than proving performance against a specific ground truth for a diagnostic AI/ML system.
§ 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.