(477 days)
CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications:
- Digital Flexor Tendons
- Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)
The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.
The information regarding the acceptance criteria and study details for the CoNextions TR Tendon Repair System is extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance (CoNextions TR) |
|---|---|---|
| Primary Safety | Rate of re-rupture of 8% or less at the 12-week follow-up visit. | 1 of 33 (3.0%) participants experienced a rupture at 12 weeks. (For all study participants: 1 of 34 (2.9%) experienced a rupture). |
| Primary Effectiveness | At least 80% of CoNextions TR repairs achieving a Strickland Score of 50% or better at the 12-week follow-up visit. | 11 of 27 (40.7%) participants had a Strickland Score of 50% or better at 12 weeks. (Goal not met). |
| Secondary Safety | No statistically significant difference in surgical site infection between groups. | Surgical Site Infection: 1/34 (2.9%) for CoNextions TR vs. 4/47 (8.5%) for Suture. No statistically significant difference. |
| No statistically significant difference in adverse events between groups. | No statistically significant differences in the frequency of any adverse events. | |
| Secondary Effectiveness | No statistically significant differences between groups for VAS Pain Scores, DASH Questionnaire Scores, Grip Strength, and Tip Pinch Strength, with differences less than minimal clinically important difference. | No statistically significant differences were seen between the two groups for these outcomes at any time point, and differences were less than the reported minimal clinically important difference. |
2. Sample Size Used for the Test Set and Data Provenance
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Test Set Sample Size:
- Initially, 90 participants were screened and randomized: 40 to the CoNextions TR group and 50 to the Suture group.
- After exclusions (8 participants under 22, 1 participant with unrelated injury), 81 participants remained.
- For the 12-week follow-up: 72 participants (88.9% of 81).
- For the 24-week follow-up: 70 participants (86.4% of 81).
- Specific numbers for CoNextions TR group and Suture group are:
- Rupture (12 weeks): 33 CoNextions TR, 45 Suture (for specific analysis 1/34 CoNextions TR, 5/47 Suture)
- Surgical site infection: 34 CoNextions TR, 47 Suture
- Strickland Score (12 weeks): 27 CoNextions TR, 41 Suture
- Strickland Score (24 weeks): 30 CoNextions TR, 42 Suture
- Secondary Effectiveness (24 weeks): N=32-33 for CoNextions TR, N=40-42 for Suture.
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Data Provenance: Prospective, multi-site clinical evaluation. The country of origin is not explicitly stated, but the FDA submission implies a US-based study or one adhering to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 5
- Qualifications of Experts: Fellowship-trained hand surgeons.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for establishing ground truth, such as a 2+1 or 3+1 consensus. The study was a clinical evaluation conducted by the involved surgeons and clinical staff, with outcomes assessed and recorded per protocol. Participants and therapists performing the majority of outcome assessments were blinded for the first 12 weeks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This was not an MRMC study and does not involve AI assistance. The study compares a novel medical device (CoNextions TR Tendon Repair System) to a standard-of-care suture repair method for tendon lacerations.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This was not a standalone (algorithm only) study. It was a clinical study comparing a medical device with a human-in-the-loop (surgical implantation) to another surgical method.
7. The Type of Ground Truth Used
The ground truth was established through direct clinical outcomes and measurements from human patients, including:
- Physical examinations for re-rupture and surgical site infection.
- Objective measurements like goniometry for Strickland's Scores (mobility).
- Patient-reported outcomes (VAS Pain Scores, DASH Questionnaire Scores).
- Strength measurements (Grip Strength, Tip Pinch Strength).
8. The Sample Size for the Training Set
The document describes a clinical evaluation for the device and provides a summary of benchtop and animal testing. It does not mention a "training set" in the context of an algorithm or AI. The term "training set" is not applicable here as this is a device performance study, not an AI/ML study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm mentioned in the document.
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.