Search Results
Found 1 results
510(k) Data Aggregation
(128 days)
The Intra-Lock Bone Fixation System is indication and fixation of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.
The Intra-Lock Bone Fixation System consists of titanium alloy self-tapping screws, which are tapered and have a minimum diameter of 1.5mm with lengths of 3mm, 6mm, 7mm, 8mm, 9mm, 10mm and 11mm and a maximum diameter of 2.0mm with lengths of 4mm, 5mm, 9mm, 11mm, 13mm, and 15mm. Tenting screws are also available in the 1.5 mm diameter. The spacer part of the tenting screws is available in 2mm, 6mm, 8mm and 10mm lengths. The screws are manufactured using Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes accessories used to fixate the screws, membranes or bone graft to the host bone including a tapered driver, and a cassette. The screws are designed for removal from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single-use only.
The provided text is a 510(k) summary for the Intra-Lock Bone Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting standalone performance studies or clinical trials with acceptance criteria for the new device itself.
Therefore, many of the requested elements about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not applicable and not found within this document. This is typical for 510(k) submissions where reliance on predicate device performance and non-clinical testing for equivalence is key.
However, I can extract information regarding non-clinical performance data and the reason for the absence of clinical data.
Section 1: Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate, the document does not present "acceptance criteria" in the traditional sense of a performance study for the new device with specific statistical targets (e.g., sensitivity, specificity). Instead, the performance is evaluated against established standards to show that the new device is as safe and effective as the predicate.
The non-clinical performance tests conducted are:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Torsion Testing (ASTM F543) | All tested Unifix screws yielded and fractured, whereas the predicate screw head stripped. (This indicates the subject device performed acceptably, though the exact "acceptance criteria" for this comparison aren't quantified beyond observing behavior.) |
| Axial Pullout Testing (ASTM F543) | No failures of the test specimen were observed. The screw pulled out of the bone foam. |
| Driving Torque Testing (ASTM F543) | No failures were observed; the screw pulled from the foam block. |
| Cleaning and Sterilization Testing (ISO 17665-1:2006(R)2013) | The Intra-Lock Bone Fixation System Kit can be steam sterilized to a sterility assurance level of at least 10^-6. |
| Biocompatibility (ISO 10993) | Not conducted for the implant as materials and manufacturing are identical to previously cleared devices (K130140, K103194). Not conducted for instruments as patient contact materials (medical grade 455 and 7-14 stainless steel) are well-known to be biocompatible. |
Section 2: Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each mechanical test. The document mentions "All tested Unifix screws" for torsion testing, implying a sufficient number for the test.
- Data Provenance: This refers to non-clinical performance data generated by the manufacturer, Intra-Lock International, Inc. It is not patient or human-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.
Section 3: Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. For mechanical and sterilization tests, ground truth is established by engineering standards (e.g., ASTM F-543, ISO 17665-1) and internal quality control, not by human experts adjudicating clinical outcomes.
Section 4: Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader disagreement. For non-clinical, objective tests, the results of the test itself determine the outcome.
Section 5: If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study was not done. This device is a bone fixation system, not an imaging or diagnostic AI device that would typically undergo MRMC studies.
Section 6: If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical device (screws), not an algorithm or AI software. Therefore, standalone performance in the context of AI is not relevant.
Section 7: The type of ground truth used
- For mechanical tests: Engineering specifications and standards (e.g., ASTM F543).
- For sterilization: Industry standards (ISO 17665-1).
- For biocompatibility: Benchmarking against previously cleared devices and accepted biocompatibility of materials (ISO 10993-1).
Section 8: The Sample Size for the Training Set
- Not applicable. This product is a physical bone fixation system, not a machine learning or AI algorithm that requires a "training set."
Section 9: How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1