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510(k) Data Aggregation
(97 days)
The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are 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 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodesis of the carpals and phalanges, steochnondritis dissecans, and ligament fixation.
The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The OsteoCentric 6.5mm to 8.0mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments, long bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and iliosacral joints, 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 (e.g. syndesmosis) as long as there is not increased morbidity associated with the insertion of a nutand-bolt system, as discussed above.
The OsteoCentric Technologies Cannulated Fasteners and Nuts 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 purpose of this submission is to modify the indications for use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
Regarding Acceptance Criteria and Supporting Study:
The document does not contain any explicit acceptance criteria or a study that proves the device meets those criteria.
Instead, the document is a 510(k) Premarket Notification for OsteoCentric Technologies' Cannulated Fasteners and Nuts. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria through new testing.
The key statement that clarifies this is:
"No performance testing was required, as no physical changes were made to the devices, the ranges of sizes are comparable to predicate devices with the same indications, and no additional testing is required for the indications modifications proposed."
Therefore, most of the requested information regarding acceptance criteria, performance data, sample sizes, and expert reviews is not applicable or not present in this specific regulatory submission. The substantial equivalence argument relies on the existing clearance of predicate devices and the lack of significant changes to the subject device that would warrant new performance testing.
However, based on the information provided, we can infer some details related to the regulatory pathway and the basis for clearance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material Composition: | |
| Stainless Steel per ASTM F138 | Device is manufactured from Stainless Steel per ASTM F138 |
| Titanium per ASTM F136 or F1295 | Device is manufactured from Titanium per ASTM F136 or F1295 |
| Technological Characteristics: | |
| Indications for Use identical to predicates | Asserted to be identical to predicates with minor modifications not raising new safety/effectiveness issues. |
| Materials of manufacture identical to predicates | Asserted to be identical to predicates. |
| Principles of operation identical to predicates | Asserted to be identical to predicates. |
| Sizes comparable to predicates | Asserted to be comparable to predicate devices with the same indications. |
| Safety and Effectiveness: | |
| Not raise new issues of safety and effectiveness compared to predicates | Concluded that minor differences do not raise new issues of safety and effectiveness. |
| No physical changes made to the devices | No physical changes were made to the devices. |
| No additional testing required for proposed indications modifications | No additional testing was required for the proposed indications modifications. |
Important Note: The "acceptance criteria" here are inferred from the substantial equivalence argument. The document explicitly states "No performance testing was required," meaning there are no new, specific quantitative performance metrics or studies reported in this submission to meet new acceptance criteria. The criteria for clearance are met by demonstrating equivalence to devices that already met prior acceptance criteria.
2. Sample size used for the test set and the data provenance
- Not Applicable. The document explicitly states: "No performance testing was required." Therefore, there was no 'test set' in the context of new performance data for this submission. The substantial equivalence is based on the characteristics of the device being analogous to already cleared predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no new performance testing was conducted, there was no test set requiring ground truth established by experts within the scope of this submission. The ground truth for the predicate devices' original clearances would have been established, but that information is not part of this document.
4. Adjudication method for the test set
- Not Applicable. No new test set or performance study was conducted.
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. This device is a medical implant (cannulated fasteners and nuts), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a medical implant, not an algorithm or software. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No new ground truth was established for this submission, as no new performance testing was conducted. The clearance is based on substantial equivalence to predicate devices, which would have had their performance and safety established through various means (including historical usage, engineering principles, and potentially prior testing) during their initial clearance processes.
8. The sample size for the training set
- Not Applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As explained above, there is no training set for this device.
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