(30 days)
The LactoSorb® Tibial L-15 Screw and Washer is indicated for the following procedures:
- ACL and PCL reconstruction
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Posterior oblique ligament repair
- Iliotibial band tenodesis reconstruction
- Patellar ligament and tendon repair
This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.
The device description of the LactoSorb® Tibial L-15 Screw and Washer is as follows:
- Resorbable screw in varying diameters
- Screw pre-assembled with a washer
- Fixation achieved by sandwiching the soft tissue between the two washers and screwing into the bone
- 85% L-Lactide/15% Glycolide copolymer
Here's an analysis of the provided information regarding the LactoSorb® Tibial L-15 Screw and Washer, focusing on the absence of information related to acceptance criteria and a study proving those criteria:
Explanation of Missing Information:
The provided document is a 510(k) Summary for a medical device. For devices seeking 510(k) clearance, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a standalone performance study.
Therefore, the document explicitly states: "Clinical Testing: None provided" and describes "Non-Clinical Testing: Mechanical testing demonstrated pull-out testing comparable to the predicate device." This means the manufacturer did not conduct a study to establish specific acceptance criteria and then demonstrate the device meets them in the way described in your request (e.g., in terms of sensitivity, specificity, accuracy, or human reader performance).
Instead, the "acceptance criteria" here are implicitly tied to demonstrating performance similar to the predicate device. The "study" proving this is the non-clinical mechanical testing that showed comparable pull-out strength.
Given this context, I cannot provide the detailed information requested in points 1-9 as it directly relates to a type of performance study that was explicitly not provided or required for this 510(k) clearance.
However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study" in the context of a 510(k) submission focused on substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent pull-out strength to the predicate device. | "Mechanical testing demonstrated pull-out testing comparable to the predicate device." |
| Material Composition: Use of similar resorbable copolymer (85% L-Lactide/15% Glycolide). | "85% L-Lactide/15% Glycolide copolymer." (Same as predicate - inferred from "similarities" abstract) |
| Overall Design/Processing: Similar to predicate device. | "The overall design, materials and processing methods are similar to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Non-Clinical Mechanical Testing): Not specified in the provided summary.
- Data Provenance: Not specified, but generally, mechanical testing for 510(k) submissions is conducted by the manufacturer or a contracted lab. It is not clinical human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This pertains to clinical studies often involving expert review of images or patient outcomes, which were not conducted for this submission. The "ground truth" for mechanical testing would be the physical properties measured by engineering instruments.
4. Adjudication method for the test set:
- Not applicable. This refers to consensus among multiple human reviewers for clinical data, which is not relevant here.
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:
- No. This type of study (MRMC, AI-assisted performance) is completely irrelevant to the submission for this particular medical device (a screw and washer) and the type of data provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical mechanical testing, the "ground truth" would be the measured physical properties (e.g., force in Newtons for pull-out strength) derived from standardized test methods.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The provided 510(k) summary for the LactoSorb® Tibial L-15 Screw and Washer demonstrates substantial equivalence to a predicate device via non-clinical mechanical testing. It does not contain information about specific acceptance criteria, clinical study results, or AI-related performance metrics because these were not part of the submission or the regulatory pathway chosen. The "acceptance criteria" were implicitly met by demonstrating "comparable" mechanical performance to the predicate device.
§ 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.