(66 days)
The EndoPearl™ With Threader is used in conjunction with a Invatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.
The EndoPearl™ With Threader Bioabsorbable Soft Tissue Device is a cannulated, sterile, sinqle-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will gradually be metabolized by the body. EndoPearl™ comes preloaded on a suture threader (with The nitinol wire) to facilitate the threading of the suture into EndoPearl™ during graft preparation by the the surgeon, resident, PA, or nurse.
The provided text describes a 510(k) submission for a medical device called "EndoPearl™ With Threader." This submission is a request to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.
Crucially, a 510(k) submission focuses on demonstrating substantial equivalence rather than proving a device meets specific acceptance criteria through a clinical study for performance.
Therefore, there is no information in the provided text regarding:
- Acceptance criteria and reported device performance in a table.
- Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used for performance evaluation.
- Sample size for training sets or how ground truth for training sets was established.
This is because the 510(k) process for a Class II device like this typically relies on non-clinical performance data (e.g., biocompatibility testing, mechanical testing) and a comparison to a predicate device to establish safety and effectiveness, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.
Based on the provided text, the core "study" that proves the device meets the criteria for market clearance is the demonstration of substantial equivalence to a legally marketed predicate device.
Here's what can be extracted and inferred from the text regarding this "study" or justification:
1. A table of acceptance criteria and the reported device performance:
- Not applicable. The provided text does not contain acceptance criteria related to clinical performance metrics or reported device performance against such metrics. The "criteria" here are those for establishing substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. There is no "test set" in the context of clinical performance evaluation described here. The submission is a comparison of characteristics to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No expert ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is described.
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 bioabsorbable fixation device, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to this submission.
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 (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" equivalent in a 510(k) context for substantial equivalence is the safety and effectiveness profile of the legally marketed predicate device. The new device is deemed "safe and effective" if it shares similar technological characteristics and intended use with the predicate, and introduces no new questions of safety or effectiveness.
8. The sample size for the training set:
- Not applicable. The concept of a "training set" for an algorithm is not relevant to this type of device submission.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of "Study" and "Acceptance Criteria" in the 510(k) Context:
-
Acceptance Criteria (for 510(k) submission): The device (EndoPearl™ With Threader) must be "substantially equivalent" to a legally marketed predicate device (EndoPearl™). Substantial equivalence means having the same intended use and technological characteristics, or if technological characteristics differ, they do not raise new questions of safety or effectiveness and the information submitted demonstrates that the device is as safe and effective as the predicate device.
-
"Study" Proving Acceptance: The entire 510(k) submission itself serves as the "proof." The key elements presented are:
- Predicate Device: EndoPearl™ (Linvatec Corporation, 510(K) # K984171)
- Comparison: A "Chart of Similarities and Dissimilarities" (Page 3 of 3) is provided, comparing the new device and the predicate device across categories such as:
- Company
- Device Name
- Intended Use
- Material
- Single-Use/Reusable
- Method of Sterilization
- Design
- Conclusion: The submission aims to demonstrate that the new EndoPearl™ With Threader is substantially equivalent to the predicate EndoPearl™ because they share the same intended use, similar materials (Poly (L-lactic acid) for the Pearl), similar design sizes (7mm, 8mm, 9mm), and both are single-use and sterilized by ETO. The primary difference is the addition of a "Threader" component (Ultem with Nitinol Wire) to facilitate suture threading, which is presented as an enhancement without altering the fundamental safety or effectiveness of the bioabsorbable fixation component.
In essence, for this 510(k) clearance, the "acceptance criteria" were met by successfully arguing to the FDA that the new device is substantially equivalent to an already cleared device, without presenting new safety or effectiveness concerns.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.