(239 days)
The NovoStitch Plus Meniscal Repair System is intended for approximation of soft tissue in meniscal repair procedures.
The NovoStitch Plus Meniscal Repair System passes size 2-0 braided, non-absorbable, 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.
The FDA 510(k) summary for the NovoStitch Plus Meniscal Repair System provides information on its acceptance criteria and the studies conducted. However, it does not contain all the requested information, especially regarding detailed statistical analysis, sample sizes for specific tests, and expert qualifications for ground truth establishment that would typically be found in a separate study report.
Here's what can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "pre-established acceptance criteria" but does not explicitly list them with specific values. Instead, it describes general claims of meeting these criteria through various tests.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Performance | |
| Device Strength & Reliability | Validated |
| Device Insertion | Validated |
| Suture Deployment | Validated |
| Device Removal | Validated |
| Reloading Capability | Validated; device can reliably deliver up to six stitches (1 provided + 5 additional) |
| Device Joint Strength | Verified |
| Delivery Device Performance | Verified |
| Suture Tensile Strength | Verified (per USP requirements for non-absorbable surgical suture) |
| Suture Diameter | Verified (per USP requirements for non-absorbable surgical suture) |
| Usability | |
| Handle Deployment Force | Demonstrated equivalent usability to predicate device |
| Biocompatibility | |
| Biocompatibility | Demonstrated compliance with ISO 10993-1 requirements for permanent implants in contact with tissue and/or bone |
| Sterilization & Packaging | |
| Sterilization | Validated |
| Packaging | Validated |
| Shelf Life | Validated |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the various tests.
- Test Set Sample Size: Not specified. The document mentions "product performance testing ... in a simulated use environment" and "bench testing."
- Data Provenance: The document implies testing was conducted by Ceterix Orthopaedics Inc. ("Product performance testing for NovoStitch Plus Meniscal Repair System was performed..."), but does not specify the country of origin of the data or if it was retrospective or prospective. Given it's premarket notification, it would be prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests seem to be primarily engineering and bench testing, not reliant on expert human interpretation for "ground truth" in the way an AI diagnostic device would be.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the "ground truth" for this device appears to be based on objective physical measurements and engineering specifications, rather than subjective expert assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices where human readers interpret results, and the document describes a surgical repair system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the NovoStitch Plus Meniscal Repair System, as it is a physical surgical device, not an algorithm or AI system. Its performance inherently involves a human operator (surgeon).
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation appears to be:
- Engineering Specifications/Standards: Such as USP requirements for suture tensile strength and diameter, and ISO 10993-1 for biocompatibility.
- Pre-established Acceptance Criteria: Defined by the manufacturer for mechanical functions (insertion, deployment, removal, strength, reliability).
- Simulated Use Environment Outcomes: Verification that the device performs its intended functions (e.g., reliably delivers stitches).
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. A "training set" is relevant for machine learning algorithms, not for physical medical devices being evaluated through bench and simulated use testing.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the same reasons as #8.
§ 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.