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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.

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The EndoPearl is used in conjunction with the Linvatec 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 BioAbsorbable Soft Tissue Device is a cannulated, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will gradually be metabolized by the body.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data. The document is a 510(k) summary for the EndoPearl device, primarily focusing on its substantial equivalence to a predicate device. While it mentions "Testing has been done to prove safety and effectiveness of the device," it does not provide the results of these tests in a way that allows for a direct answer to your detailed questions about acceptance criteria and device performance metrics.

However, based on the limited information, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or report specific performance metrics like accuracy, sensitivity, or specificity. The "performance" described is centered around its intended use and bioabsorbability.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text only vaguely states "Testing has been done" without details on sample size, data type, or provenance.

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)

This information is not provided in the document. The general nature of the device (implantable fixator) suggests that "ground truth" would likely be established through biomechanical testing, animal studies, or clinical observations rather than expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This is not applicable to the EndoPearl device. The EndoPearl is a physical medical device (a fixation device), not an AI algorithm or a diagnostic tool that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the EndoPearl is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify the precise "ground truth" used for testing. For a bioabsorbable fixation device, ground truth would typically relate to:

• Biomechanical performance: Strength, degradation rate, load-bearing capacity.
• Biocompatibility: Lack of adverse tissue reaction.
• Clinical outcomes: Successful fixation, absence of complications, healing process.
  However, no details are provided.

8. The sample size for the training set

This information is not provided. As the device is not an AI algorithm, the concept of a "training set" in the context of machine learning is not directly applicable.

9. How the ground truth for the training set was established

This information is not provided and is not applicable in the context of a physical medical device.

Ask a specific question about this device