(30 days)
The OsteoCentric 2.4mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The OsteoCentric Trauma 7.0mm and 8.0mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.
The OsteoCentric Technologies Cannulated Fasteners and Nuts within the product line of the SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295.
The provided text describes a 510(k) premarket notification for "Cannulated Fasteners and Nuts" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for a novel AI/ML-based medical device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.
However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.
Here's a summary based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it states that "OsteoCentric Technologies has conducted mechanical testing with engineering analyses and geometric comparisons to demonstrate that the modifications to the SMV Scientific Cannulated Screws provide adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use." This implies the acceptance criteria were based on demonstrating mechanical performance comparable to the predicate devices.
The reported performance is qualitative, stating that the device provides "adequate and substantially equivalent mechanical performance" for the tested parameters.
Performance Testing Summary
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|---|
| Mechanical Strength | Performance comparable to legally marketed predicate devices for their intended use, demonstrating substantial equivalence. (Specific thresholds are not provided in the document). | "adequate and substantially equivalent mechanical performance (torsional strength, driving torque, and pullout strength) for their intended use." |
| Torsional Strength | (Implied: Engineering analysis supports substantial equivalence to predicates.) | Engineering analysis conducted. (Specific values or comparison results are not provided). |
| Pullout Resistance | (Implied: Engineering analysis supports substantial equivalence to predicates.) | Engineering analysis conducted. (Specific values or comparison results are not provided). |
| Driving Torque | Per ASTM F543 (Implied: Results meet or are comparable to predicate performance and standard requirements). | Testing completed per ASTM F543. (Specific values or comparison results are not provided). |
| Cleaning Validation | Per AAMI TIR12:2010 and ANSI/AAMI TIR30:2011 (Implied: Validation demonstrates effective cleaning). | Validation completed. (Specific results or acceptance criteria for cleaning are not detailed). |
| Sterilization Validation | Per AAMI TIR12:2010 (Implied: Validation demonstrates effective sterilization). | Validation completed. (Specific results or acceptance criteria for sterilization are not detailed). |
| Geometric Comparison | Device characteristics (e.g., sizes) are nearly identical to predicates. | "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates: - Indications for Use - Materials of manufacture - Principles of operation - Sizes" |
Other Requested Information (Not Applicable or Not Provided in this Document)
The document is a 510(k) summary for a standard orthopedic implant (cannulated fasteners and nuts), not an AI/ML-based device. Therefore, the following information is not present or not relevant in this context:
- Sample size used for the test set and the data provenance: Not applicable. The testing described is mechanical, not based on a "test set" of patient data in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert radiologists assessing images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" would be the results obtained from standardized mechanical tests (e.g., peak torque, ultimate tensile strength) and comparison to established engineering specifications or predicate device performance.
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable.
§ 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.