(29 days)
The NovoStitch Pro Mensical Repair System is intended for approximation of soft tissue in meniscal repair procedures.
The NovoStitch Pro Meniscal Repair System, size 0 is a new configuration of the predicate device. While the predicate device passes size 2-0 suture, this new configuration passes size 0 braided, nonabsorbable, surgical suture through soft tissue in arthroscopic surgery. It is comprised of a handheld surgical instrument to which cartridges preloaded with suture are attached.
Here's an analysis of the provided text regarding the NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0), focusing on acceptance criteria and the supporting study:
The provided document is a 510(k) summary for the NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0). This document is primarily concerned with demonstrating substantial equivalence to a predicate device (NovoStitch Pro Meniscal Repair System, CTX-A003 (size 2-0)) rather than detailing a comprehensive study with specific acceptance criteria in the manner one might find for a novel AI/software device. The device in question is a surgical instrument that deploys sutures.
Therefore, the information you've requested regarding AI/software performance metrics (like sensitivity, specificity, MRMC studies, training set details, ground truth establishment for training, etc.) is not applicable to this submission, as it describes a mechanical surgical device and not a software-based diagnostic or therapeutic aid.
However, I can extract the relevant information concerning the device's acceptance criteria and performance as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of numerical acceptance criteria with corresponding performance values in the way software performance data might be presented (e.g., "sensitivity > X%" and "achieved Y%"). Instead, it describes general categories of testing and the successful outcomes. The acceptance criteria are implied by the nature of the tests conducted and the statements that the device "meet all pre-established acceptance criteria."
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Device Strength | Testing performed in a simulated use environment; device met all pre-established acceptance criteria. |
| Device Reliability | Testing performed in a simulated use environment; device "can reliably deliver up to six stitches. This includes the preloaded handle assembly and up to five additional cartridges." Device met all pre-established acceptance criteria. |
| Device Insertion | Testing performed in a simulated use environment; device performed as expected. Device met all pre-established acceptance criteria. |
| Suture Deployment | Testing performed in a simulated use environment; device performed as expected. Device met all pre-established acceptance criteria. |
| Device Removal | Testing performed in a simulated use environment; device performed as expected. Device met all pre-established acceptance criteria. |
| Ability to Reload with Suture Cartridges | Testing performed in a simulated use environment; device demonstrated the ability to reload with new suture cartridges to perform additional device insertions, deployments, and removals. Device met all pre-established acceptance criteria. |
| Device Joint Strength | Verification testing included device joint strength evaluation; device met all pre-established acceptance criteria. |
| Device Performance Evaluations | Verification testing included device performance evaluations; device met all pre-established acceptance criteria. |
| Sterilization | Validated or adopted from previous testing. |
| Packaging | Validated or adopted from previous testing. |
| Shelf Life | Validated or adopted from previous testing. |
| Biocompatibility (Suture) | "met all biocompatibility requirements for permanent implants in contact with tissue and/or bone" (ISO 10993-1 compliant). |
| Biocompatibility (Delivery Handle - patient contact portions) | "met all requirements for limited duration contact with tissue and/or bone" (ISO 10993-1 compliant). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test category, nor does it detail data provenance in terms of country of origin or retrospective/prospective studies. It states "Product performance testing for the NovoStitch Pro Meniscal Repair System, size 0 was performed in a simulated use environment." This implies these were bench tests focused on the device's mechanical and functional capabilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a surgical instrument, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device would be its ability to physically perform its intended function (e.g., deploy a suture correctly, maintain strength).
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. Adjudication methods are typically for subjective assessments or disagreements in diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size with AI Assistance
This is not applicable. The device is a surgical tool, not an AI-assisted diagnostic or therapeutic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on engineering and functional specifications in a simulated use environment (bench testing) and ISO standard requirements for biocompatibility. For instance, whether the suture was reliably deployed, if the device maintained its strength, and whether material components met biocompatibility standards.
8. The Sample Size for the Training Set
This is not applicable. The device is not a machine learning model, and thus does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
§ 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.