(85 days)
The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. buckethandle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
The JuggerStitch Meniscal Repair Device is a permanent fixation anchor system comprised of UHMWPE suture, with two non-resorbable polyester sleeves. The device comes as a unit, preassembled on either a straight or curved inserter.
I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device, the JuggerStitch Meniscal Repair Device, and primarily focuses on establishing substantial equivalence to a predicate device.
Here's what I can extract and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "non-clinical laboratory testing was performed to verify the fixation strength of the JuggerStitch Meniscal Repair Device in mechanical testing as compared to the MaxFire MarXmen Meniscal Repair Device." It then states, "The test results indicate that the JuggerStitch Meniscal Repair Device provides equivalent fixation strength to the predicate device and would be functional within their intended use."
However, specific numerical acceptance criteria (e.g., minimum fixation strength in Newtons) and the exact reported performance values for both the JuggerStitch and the predicate device are not provided. Therefore, a table with specific acceptance criteria and reported performance cannot be generated from this text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document.
- Data Provenance: The document states "non-clinical laboratory testing was performed." It does not mention country of origin or whether it was retrospective or prospective, though "non-clinical laboratory testing" typically implies a controlled, prospective lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was non-clinical mechanical testing, not a study requiring expert clinical ground truth assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this was non-clinical mechanical testing.
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 MRMC or human-in-the-loop study was mentioned. The device is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical mechanical testing, the "ground truth" or reference was the fixation strength of the predicate device. The goal was to show equivalence.
8. The sample size for the training set:
- Not applicable. This document describes a non-clinical performance test for a physical device, not a machine learning model that would have training data.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a 510(k) summary that focuses on demonstrating substantial equivalence through comparison to a predicate device, primarily via non-clinical mechanical testing. It does not provide the detailed quantitative data, sample sizes for mechanical testing beyond a general statement, or information on clinical studies, expert reviews, or AI performance metrics.
§ 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.