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510(k) Data Aggregation
(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.
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(44 days)
PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.
PARIETEX™ PROGRIP™ Mesh will be available in 2 shapes:
Pre-cut, elliptic slit mesh with a self-gripping overlapping flap. Right or left side.
Rectangular simple mesh.
These meshes and the overlapping flaps of the pre-cut versions are made from knitted monofilament polyester with monofilament polylactic acid (PLA) resorbable pins on one side. The PLA pins facilitate placing, positioning and fixation of the overlapping flap and the meshes to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps in orientation.
The acceptance criteria and study proving device performance are not explicitly detailed within the provided text beyond a general statement that "Bench and animal testing has been conducted to evaluate the performance characteristics of PARIETEX™ PROGRIP™ Mesh. Results of mechanical property testing show that PARIETEX™ PROGRIP™ has similar performance characteristics to the predicate PARIETEX™ Mesh."
Therefore, I cannot provide a detailed table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, or specifics on ground truth establishment for a training set.
Based on the provided information, I can deduce the following:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Properties | Similar performance characteristics to the predicate PARIETEX™ Mesh. |
| Material Biocompatibility | Comprised of materials that have been evaluated in accordance with ISO 10993-1 and/or USP standards. |
2. Sample sized used for the test set and the data provenance
- Test set sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Bench and animal testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study involved bench and animal testing, not human expert evaluations for establishing ground truth in the context of diagnostic performance.
4. Adjudication method for the test set
Not applicable. The study involved bench and animal testing.
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
No. This is a medical mesh device, not an AI-powered diagnostic tool, so an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical mesh device, not an algorithm.
7. The type of ground truth used
For mechanical properties, the "ground truth" would be established by predefined engineering specifications or comparison against the predicate device's measured performance. For material biocompatibility, the "ground truth" is adherence to ISO 10993-1 and/or USP standards.
8. The sample size for the training set
Not applicable. This is a medical mesh device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use a training set in the context of machine learning.
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