(225 days)
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
| Acceptance Criteria (Internal/External Standards) | Reported Device Performance |
|---|---|
| Internal specification requirements | All data fell within internal specification requirements. |
| External standard requirements | All data fell within external standard requirements. |
| Device performance expectations | All data fell within device performance expectations. |
| USP standards (for suturing products) | Compared to USP standards. |
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.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.