(84 days)
Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screws are not intended for interference or soft tissue fixation.
Acutrak 3 Headless Compression Screw System is a set of screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Acutrak 2 Headless Compression Screw Systems, per K930834, K944330 and K221333.
Acutrak 3 Headless Compression Screw System screws are designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The system provides screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.
The AT3 System screws are an extension of the Acutrak family with new lengths and the addition of a new smaller screw size. AT3 System screws include 4 sizes, which are referred to as Nano, Micro, Mini and Standard. The screw naming scheme is not to imply the presence of any additional features in the screws. Screws are intended for single patient use only. The AT3 System introduces a modified variable pitch screw design designed to accommodate various fracture patterns for which the AT3 System can be used.
Instruments supplied with the AT3 System are intended to aid in the screw insertion and removal. Instruments are supplied sterile, to be sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.
The provided text is a 510(k) summary for a medical device (Acumed Acutrak 3 Headless Compression Screw System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing.
Crucially, this document does not describe a study involving an AI/Machine Learning (AI/ML) powered device that would have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance improvement.
The "device" in this context is a physical medical implant (a bone screw system), not a software or AI-powered diagnostic/analytic tool. Therefore, the questions related to AI/ML device performance metrics (such as acceptance criteria for AI algorithms, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and material performance of the physical screw system, through non-clinical bench testing.
However, to directly answer your request based on the provided text, and to clarify that the nature of the device means many of your specific questions are not relevant, here's what can be extracted:
Device: Acumed Acutrak 3 Headless Compression Screw System
Type of Device: Physical medical implant (bone screw system)
Study Focus: Non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices and ensure safety and performance of the physical screw system.
1. A table of acceptance criteria and the reported device performance:
The document lists the non-clinical tests performed, implying that the device "passed" or "met" the performance requirements for these tests to be deemed substantially equivalent. The specific acceptance criteria values (e.g., minimum torsional yield strength in Nm) and reported performance values for each test are not explicitly provided in this summary. They would typically be in the full submission, but not in the public 510(k) summary.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance (Implied Result) |
|---|---|
| Meet Torsional Yield Strength per ASTM F543 Annex A1 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet Driving Torque per ASTM F543 Annex 2 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet Axial Pullout Force per ASTM F543 Annex 3 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet Self-Tapping Performance per ASTM F543-17 Annex 4 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Sterilization per ISO 17665-1 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Sterilization per ISO 11137-1 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Packaging integrity per ISO 11607-1 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Biocompatibility per ISO 10993-1 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet Screw Lifetime Verification Testing | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet Self-Drilling Verification Testing | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet Magnetically Induced Displacement Force per ASTM F2052 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet Magnetically Induced Torque per ASTM F2213 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Meet MR Image Artifact per ASTM F2119 | Performance data demonstrate equivalence to predicate; safe and effective. |
| Allow MRI Safety Labeling per ASTM F2503 | Performance data demonstrate equivalence to predicate; 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):
- Sample Size for Test Set: Not specified in the summary. For mechanical tests like these, sample sizes are typically determined by the relevant ASTM standards or internal validation protocols.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing related to the manufacturer (Acumed LLC, based in Hillsboro, Oregon, United States). These are laboratory bench tests, not clinical data from patients. The terms "retrospective" or "prospective" are not applicable to this type of device testing.
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 question is not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not established for this type of non-clinical, mechanical device testing. The "ground truth" for these tests are the objective measurements against
established engineering and material science standards (e.g., precise force measurements, torque values, etc.).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. Adjudication methods are relevant for cases where human experts interpret data (e.g., medical images) to establish a ground truth. For mechanical testing of a medical implant, the results are measured directly against predefined engineering and material standards.
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 question is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic aids where human readers are involved in interpreting medical cases. This device is a surgical implant, not an AI diagnostic tool. The document explicitly states: "Clinical testing was not necessary."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This device is a physical screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device testing relies on adherence to international and national engineering standards (e.g., ASTM, ISO) for material properties and mechanical performance. The device's performance is measured directly against the specifications and requirements outlined in these standards, and in comparison to predicate devices.
8. The sample size for the training set:
This question is not applicable. This device is a physical product, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This question is not applicable. As above, there is no "training set" for a physical medical implant.
§ 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.