(29 days)
The NovoStitch Pro Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
The NovoStitch Pro Meniscal Repair System is a next generation of the predicate device, the NovoStitch Plus Meniscal Repair System. The NovoStitch Pro Meniscal Repair System passes size 2-0 braided, nonabsorbable, polyethylene surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with polyethylene suture are attached.
This document describes the NovoStitch Pro Meniscal Repair System, a device for meniscal repair procedures. The provided text is a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to a predicate device. As such, it does not detail specific acceptance criteria for performance metrics or present a comprehensive study proving the device meets those criteria in the way one might find for a novel device with new performance claims (e.g., diagnostic accuracy for an AI system). Instead, it discusses the types of tests performed to ensure the device's basic functionality, safety, and equivalence to the predicate.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding performance metrics like sensitivity, specificity, or AUC, as these types of metrics are not typically applicable to a mechanical surgical device like a suture delivery system in the same way they are for diagnostic AI.
However, the text describes types of tests performed and some general statements of successful verification:
| Acceptance Criteria (Implied from Testing) | Reported Device Performance |
|---|---|
| Device strength | Verified |
| Device reliability | Verified |
| Device insertion | Validated |
| Suture deployment | Validated |
| Device removal | Validated |
| Ability to reload with new cartridges | Validated |
| Ability to reliably deliver up to six stitches | Demonstrated |
| Device joint strength | Evaluated |
| Device performance evaluations | Evaluated |
| Biocompatibility (suture implant) | Met all requirements for permanent implants in contact with tissue and/or bone |
| Biocompatibility (patient contact portions of delivery handle) | Met all requirements for limited duration contact with tissue and/or bone |
| Human factors and usability processes for six essential tasks | Conducted and conformed to FDA guidance |
2. Sample Size for Test Set and Data Provenance
- Test Set (Human Factors/Usability): The study used 15 orthopedic surgeons.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective for the engineering/bench testing. For human factors, it was a usability study conducted in conformance with FDA guidance, implying a prospective design.
3. Number of Experts and Qualifications for Ground Truth
- For the human factors and usability testing, 15 orthopedic surgeons served as participants. Their qualifications are stated simply as "orthopedic surgeons." The study involved them being "trained on the use of the NovoStitch Pro per the Instructions for Use, followed by a quantitative assessment." In this context, their performance of tasks is the data being evaluated, rather than them establishing a ground truth for an external dataset.
- For bench testing and biocompatibility, the ground truth is established by standards (e.g., ISO 10993-1) and internal engineering specifications, not by clinical experts in the same way as, for example, reading medical images.
4. Adjudication Method for Test Set
- Not Applicable in the traditional sense for diagnostic performance. For the human factors study, the method was a "quantitative assessment of the human factors and usability processes for six essential tasks." This likely involved metrics such as task completion rates, errors, and time to completion, rather than an expert adjudication process to resolve disagreements on a subjective classification.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices or AI systems where multiple human readers interpret cases, and their performance with and without AI assistance is compared. The NovoStitch Pro is a surgical device, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. This is also not applicable as the NovoStitch Pro is a mechanical surgical device, not an AI algorithm.
7. Type of Ground Truth Used
- Bench Testing: Ground truth is based on engineering specifications, physical measurements, and industry standards (e.g., for strength, reliability, proper articulation).
- Biocompatibility: Ground truth is based on international standards, specifically ISO 10993-1, and specific testing protocols to determine material compatibility with biological systems.
- Human Factors/Usability: Ground truth is based on established human factors principles and the successful or unsuccessful completion of predefined essential tasks by the users (orthopedic surgeons) according to the device's Instructions for Use.
8. Sample Size for Training Set
- Not Applicable. The NovoStitch Pro is a mechanical device, not an AI system, so there is no "training set" in the context of machine learning.
9. How Ground Truth for Training Set Was Established
- Not Applicable. As there is no training set for an AI algorithm. The device's design and manufacturing rely on engineering principles, material science, and established medical device development standards.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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.