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The Acumed Pelvic Bone Plate System includes plates, screws, and accessories designed to provide fixation during fractures, fusions, and osteotomies for the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions. Plates are available in a variety of shapes and sizes which can be used "as is" or additionally contoured and/or trimmed intraoperatively to accommodate varying injury patterns and/or patient anatomy. All plates are made of titanium per ASTM F67 and are designed to accommodate the 3.5mm screws included in the system. Plates range in length from 30mm to 250mm, have a width of 4mm to 17mm, and a thickness of 1.5mm to 4mm. The system includes 3 families of screws with different diameters: 2.7mm, 3.5mm, and 4.3mm. All screw families can be used for fixation independent of the plates. Screws are made of titanium alloy per ASTM F136. All implants are provided sterile and non-sterile.

The provided document is a 510(k) summary for the Acumed Pelvic Bone Plate System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study in the way a new drug or novel high-risk device might.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets is not applicable to this specific type of regulatory submission (510(k) for a Class II metallic bone fixation appliance).

Here's why and what information is available in the document:

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

• Not Applicable. The 510(k) process for this device type typically relies on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and performance through non-clinical bench testing, rather than setting and meeting specific clinical performance acceptance criteria. The document does not define such criteria or report on device performance against them.

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

• Not Applicable. No clinical "test set" and associated data provenance are mentioned because clinical studies are generally not required for this type of 510(k) submission.

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):

• Not Applicable. As no clinical test set requiring ground truth establishment is described, this information is not relevant.

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

• Not Applicable. No clinical test set to adjudicate is mentioned.

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:

• Not Applicable. The device is a physical bone plate system, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effect sizes are irrelevant.

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

• Not Applicable. The device is a physical bone plate system, not an algorithm.

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

• Not Applicable. No clinical ground truth is established for this type of submission.

8. The sample size for the training set:

• Not Applicable. The device is a physical bone plate system, not a machine learning model that requires a training set.

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

• Not Applicable. Not a machine learning model.

What the document does provide regarding device performance and equivalence:

The document states:

• "The non-clinical testing included in this submission includes testing to ASTM F382 and F543." These are industry standards for:

  • ASTM F382: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) (While the F382 mentioned in the document is likely referring to a test method, the common ASTM standards for implant materials are F67 for commercially pure titanium and F136 for titanium alloy, both of which are listed in the material comparison table.)
  • ASTM F543: Standard Specification for Metallic Medical Bone Screws (This standard specifies requirements for metallic bone screws, including mechanical properties and test methods.)

• The purpose of this testing is to demonstrate that the Acumed Pelvic Bone Plate System performs mechanically similarly to the legally marketed predicate devices. The conclusion in the 510(k) summary is: "There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Pelvic Bone Plate System is substantially equivalent to the predicate devices."

In summary, for a traditional 510(k) for a Class II orthopedic implant, the "acceptance criteria" are typically the demonstration of substantial equivalence through design comparisons, material compliance to ASTM standards, and non-clinical mechanical testing that shows the device meets the performance characteristics expected of such devices and is comparable to predicate devices. Clinical performance studies with detailed acceptance criteria and expert reviews are generally not required at this stage unless there are significant differences in technology or intended use that raise new questions of safety or effectiveness.

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