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510(k) Data Aggregation
(113 days)
The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture.
The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.
The Digitex SDS is composed of delivery device and suture cartridge and is designed for use by the physician to facilitate the consistent placement of suture when direct visualization is not possible and/or the anatomical location is difficult to reach. The shaft of the delivery device has been designed to allow for adjusting the angle of the needle housing to further facilitate suture placement in the desired location. The suture cartridges are provided pre-loaded with non-absorbable polypropylene, absorbable polydioxanone, or absorbable polyglycolic acid coated suture.
The provided text describes a 510(k) summary for the Digitex Suture Delivery System (SDS) and associated FDA correspondence, focusing on the substantial equivalence of modifications to the suture cartridges. However, it does not explicitly detail acceptance criteria or a specific study proving the device meets numerical acceptance criteria in the way typically expected for performance metrics (e.g., sensitivity, specificity for diagnostic devices).
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify numerical acceptance criteria for device performance. Instead, the acceptance criteria are implicitly related to demonstrating "substantial equivalence" to predicate devices, focusing on design specifications and safety.
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Nonclinical Tests) |
|---|---|---|
| Device Function (Modifications to Suture Cartridges) | Meet established design specifications for the modified Digitex Suture Cartridges (adding polydioxanone and polyglycolic acid coated absorbable sutures). | Evaluated via design verification testing and simulated use tests in a cadaveric laboratory. Confirmed that the modified Digitex Suture Cartridges meet established design specifications and are substantially equivalent to the predicate polypropylene Digitex Suture Cartridges. |
| Biocompatibility | Acceptable biocompatibility profile for the proposed absorbable Digitex Suture Cartridges. | Predicate Digitex Suture Cartridges previously subjected to biocompatibility testing (K093112) with acceptable results, which apply to the proposed absorbable cartridges. Additional evaluation and testing were conducted, demonstrating an acceptable biocompatibility profile for the proposed absorbable Digitex Suture Cartridges. |
| Sterilization Method & Sterility Assurance Level (SAL) | Meet requirements of ISO 11135 and ISO 10993-7 for sterilization method, SAL, and modified sterile barrier. | The sterilization method and SAL have not changed. The change to the contract sterilization facility and modified sterile barrier have been evaluated and meet the requirements of ISO 11135 and ISO 10993-7. |
| Overall Equivalence | Demonstrate substantial equivalence to predicate devices (Digitex Suture Delivery System: K093112, Deknatel Deklene II suture, K930738; Monodek PDO suture, K030212; and Bondek PGA suture, K991191 & K992088) in intended use and fundamental scientific technology. | The Digitex Suture Delivery System is concluded to be substantially equivalent to the predicates, having the same intended use and fundamental scientific technology. The modifications were evaluated through design verification and simulated use tests, and additional biocompatibility and sterilization evaluations, all demonstrating fulfillment of established design specifications and equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The document mentions "simulated use tests in a cadaveric laboratory" as part of the evaluation for the modified suture cartridges. However, it does not specify the sample size for this test set (e.g., number of cadavers, number of sutures placed).
- Data Provenance: The simulated use tests were conducted in a "cadaveric laboratory." This implies human cadaveric tissue. The country of origin is not specified, but the applicant is from Denmark, and the contact is in the USA. Given this is a 510(k) submission to the FDA, it's likely testing was conducted to US standards. The study is retrospective in the sense that it's a controlled laboratory test, not an observational study of live patients over time.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish a "ground truth" in the context of diagnostic performance or clinical interpretation. The testing performed ("design verification testing and simulated use tests") focuses on the physical and functional performance of the device itself and its components. The judgment of whether "design specifications" are met would typically be done by engineers and quality control personnel, not clinical experts establishing ground truth for data interpretation.
4. Adjudication Method
Not applicable. Since there's no mention of expert evaluation of cases or data interpretation to establish a ground truth for performance metrics, there is no adjudication method described.
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. The study described is a nonclinical, device-centric evaluation, not a study assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical tool (suture delivery system and cartridges), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this device revolves around its physical and functional performance meeting established design specifications for safety and efficacy in surgical use, and demonstrating substantial equivalence to predicate devices. This is assessed through:
- Design verification testing: Verifying the device's physical properties, mechanical integrity, and functional operation.
- Simulated use tests in a cadaveric laboratory: Demonstrating the device performs its intended function (suture delivery, passing a needle, holding suture) in a realistic anatomical setting.
- Biocompatibility testing results: Ensuring the materials are safe for use in the human body.
- Sterilization validation: Confirming the device can be sterilized effectively to prevent infection.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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