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These LSI SOLUTIONS® suture placement products are intended for use in the approximation of soft tissue and prosthetic materials.

LSI SOLUTIONS® Suture Placement Devices, Accessories and Quick Load® products, specifically the RD-180 suturing device and its 2-0 non- absorbable polyester and polypropylene suture load units along with the TK Ti-Knot® knot replacement device and its Titanium Knot® loads, will effectively approximate tissue and prosthetic material.

The provided document describes the LSI SOLUTIONS® Suture Placement Devices and Accessories, detailing their intended use and the testing conducted for their 510(k) premarket notification (K100593).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All data fell within internal specification requirements, as well as external standard requirements and device performance expectations" and that the product was compared to Coalescent U-Clip® predicate device and USP standards. However, specific quantitative values for these standards or the device's performance against them are not provided in this summary. The summary indicates successful compliance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: "Multiple tests were performed covering a variety of different prosthetic material types." A precise numerical sample size for the test set is not explicitly stated.
• Data Provenance: The study employed an ex-vivo porcine tissue model. This indicates the data was collected from animal tissue, not human subjects. The country of origin for this specific ex-vivo model is not specified. The study is characterized as a "Prosthetic Fixation Study," suggesting it was conducted specifically for this submission, likely making it prospective for the purpose of the 510(k).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document does not mention the use of experts to establish ground truth for the "Prosthetic Fixation Study." This type of study, involving mechanical testing on ex-vivo tissue, typically relies on quantitative measurements and comparisons against established standards rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

• An adjudication method is not applicable and therefore not mentioned, as the study involves objective mechanical testing on tissue models rather than subjective clinical assessments that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The study described is a "Prosthetic Fixation Study" using an ex-vivo porcine tissue model, which is a bench-top/pre-clinical study, not a clinical study involving human readers or cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable to this device. The LSI SOLUTIONS® device is a physical surgical instrument (suture placement device and accessories), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

• The "ground truth" for the "Prosthetic Fixation Study" appears to be based on objective measurements and comparisons against established industry standards (e.g., USP standards) and internal/external specifications for prosthetic fixation performance (e.g., tensile strength, knot security). It is not pathology, outcomes data, or expert consensus in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reason as point 8.

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The LSI Suture Placement device and accessories are intended for use in the approximation of soft tissue.

The LSI Suture Placement device and accessories are intended for the approximation of surgical wounds by passing ligature through soft tissue.

This 510(k) premarket notification for the LSI Suture Placement Device and Accessories does not contain specific acceptance criteria or an associated study proving the device meets criteria using performance metrics. This submission relies on substantial equivalence to a predicate device rather than performance testing against defined metrics.

Here's a breakdown of why the requested information cannot be fully provided based on the given text:

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

   • No specific acceptance criteria or performance metrics are listed. The submission focuses on comparing the LSI Suture Placement Device and its accessories to a predicate device (AUTO SUTURE* Suture Closure** device and accessories, K954853) based on "design, function, and indicated use."
   • The comparison table lists functional aspects (delivering suture materials, approximating soft tissue, biocompatible materials, sterilization method, packaging) and states they are the "same" between the subject and predicate devices. These are not quantitative performance metrics with associated acceptance criteria.

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

   • No test set or performance evaluation data are described. The submission is a premarket notification based on substantial equivalence, not a clinical trial or performance study report.

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. There is no test set or ground truth established for performance evaluation within this document. The "ground truth" for the submission's purpose is the established safety and effectiveness of the predicate device.

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

   • Not applicable. No test set or related adjudication method is mentioned.

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 manual surgical instrument, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant here.

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

   • Not applicable. This is a hardware surgical device, not an algorithm.

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

   • Not applicable in the context of a performance study. The basis for approval is substantial equivalence to a legally marketed predicate device, implying that the predicate's established safety and effectiveness serve as the "ground truth" for the new device's comparable attributes.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a training set.

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

   • Not applicable. This device does not involve machine learning or a training set.

Summary based on the provided text:

The LSI Suture Placement Device and Accessories received 510(k) clearance based on its substantial equivalence to a predicate device (AUTO SUTURE* Suture Closure** device and accessories, K954853). The submission argues that both devices share the same:

• Design
• Function (deliver suture materials, approximate soft tissue)
• Indicated Use (approximation of soft tissue)
• Materials (biocompatible)
• Sterilization method (ethylene oxide, 10-6 lethality)
• Packaging (disposable, thermoformed blister with TYVEK™ cover)

Therefore, no specific performance acceptance criteria or study results are presented within this document because the regulatory pathway chosen (510(k) premarket notification for substantial equivalence) does not typically require novel clinical or performance studies for devices considered substantially equivalent to already marketed devices. The FDA's letter states that the device can be marketed subject to general controls, and assumes compliance with Good Manufacturing Practice (GMP) requirements.

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