Search Results
Found 3 results
510(k) Data Aggregation
(484 days)
The SternaFuse® Fixation System is indicated for use in the stabilization of fractures of the anterior chest wall, including stemal fixation following sternal fractures, and sternal reconstructive surgical procedures, to promote fusion. The device is for prescription use only.
The SternaFuse® Fixation System implants are composed of 316 LVM implant quality stainless steel plates, links, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in two diameters, 3.0mm and 3.3mm, and lengths of 10mm, 13mm, and 16mm. Multiple plates may be used in one anterior chest wall repair. Variable Assemblies can be configured, and the Links angled for optimum fixation. Implants are designed with centralized saddles to aid in intra-operative contouring, to facilitate cutting during postoperative emergent re-entry, and to provide a location for stainless steel wire.
The implants are individually packaged and sterilized, allowing the surgeon to customize the desired implants for the specific needs of the patient. All implants are provided sterile with a five-year shelf-life. The implants should never be reused under any circumstance.
This document is a 510(k) premarket notification for a medical device called the SternaFuse® Fixation System. It details the device's indications for use, description, comparison to predicate devices, and performance data.
From the provided text, there is no information about a study that describes acceptance criteria or performance for an AI/CADeX device. The document focuses on a physical medical device (bone fixation system) and its mechanical, material, and sterility testing, not on software or AI performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI/CADeX device, nor can I answer questions about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training/test set details for such a device from this document.
The "Performance Data" section (Section 9) exclusively discusses:
- Biocompatibility (Section 9.1): Assessed according to ISO 10993-1 for 316LVM Stainless Steel.
- Pyrogenicity/Endotoxin Testing (Section 9.2): Performed to meet acceptance criteria of
Ask a specific question about this device
(135 days)
The Gabriel® Feeding Tube with Balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short to moderate term feeding support, such as post-trauma patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.
The Gabriel Feeding Tube with Balloon serves as conduit through which enteral feeding solutions are directly infused into patients small bowel. The tube has two distal end openings, one distal end balloon, one proximal end pilot balloon that indicates the status of the inflation of the distal end balloon and a proximal end EnFit connector that replaced our Y shaped catheter tip connector of the predicate device. The tube shaft is lined by a monofilament spiral wire to prevent occlusion from kinking. A braided 7 strands stainless steel stiffening central stylet prevents coiling in the mouth during insertion and provides column strength to facilitate placement into the stomach.The tube patient contacting material is made from DEHP-free PVC. Size 12 Fr tube is 130 cm long.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Gabriel® Feeding Tube with Balloon, and EnFit Connector." This document focuses on demonstrating substantial equivalence to a predicate device (K160787) rather than providing detailed acceptance criteria and study results for a novel AI/software-as-a-medical-device (SaMD) product.
Therefore, the information required to answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not present in the provided text. The document describes a traditional medical device (a feeding tube) and its physical and functional characteristics, along with non-clinical tests for its performance and safety compared to its predicate.
Here's what can be extracted from the document regarding the device and its testing, but it does not fulfill the prompt's request for AI device study details:
Device Description and Purpose:
The Gabriel® Feeding Tube with Balloon, and EnFit Connector is a nasoenteral feeding tube designed to facilitate enteral feeding in adult or elderly patients who cannot orally consume an adequate diet. It's intended for bedside insertion and use in patients requiring short to moderate-term feeding support. Key features include a distal end balloon for peristaltic advancement and airway misplacement detection, a flexible shaft with a spiral wire to prevent kinking, and a central stainless steel stylet for insertion. The primary changes from the predicate device are the replacement of a Y-shaped catheter tip connector with a rigid male EnFit connector to mitigate misconnection risk, a change from MR unsafe to MR conditional, and the addition of certain items to a convenience kit.
Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing for Substantial Equivalence):
As this is a physical medical device and not an AI/SaMD, the "acceptance criteria" are implied by successful completion of mechanical, functional, and safety tests to demonstrate equivalence to a predicate device. The reported performance is that the device "passed" these tests.
| Acceptance Criteria Category/Test | Reported Device Performance |
|---|---|
| Functional Equivalence | |
| Feeding formula flow rate test (model with EnFit connector vs. predicate with catheter tip connector) | Pass |
| Mechanical Integrity/Safety | |
| Tube shaft to male EnFit connector tensile test | Pass |
| Stylet to stylet hub tensile test | Pass |
| Leakage by pressure decay test (EnFit connector) | Pass |
| Positive pressure liquid leakage test (EnFit connector) | Pass |
| Stress cracking test (EnFit connector) | Pass |
| Resistance to separation from Axial load test (EnFit connector) | Pass |
| Resistance to separation from unscrewing test (EnFit connector) | Pass |
| Thread overriding resistance test (EnFit connector) | Pass |
| Dimensional Conformance | |
| Dimensional verification of EnFit connector | Pass |
| Material Properties | |
| EnFit connector material elasticity modulus above 700 MPa | Pass |
| Shelf Life | |
| 48 Months shelf life test (on device with catheter tip connector, applied to new device) | Pass (shelf life increased to 48 months) |
| Biocompatibility | |
| Cytotoxicity, sensitization, acute and sub-acute toxicity tests of materials | Confirmed biocompatible |
| MR Safety | |
| MR safety test | MR Conditional |
Information NOT available in the provided text (as it pertains to AI/SaMD studies):
The prompt specifically asks for details related to AI/SaMD acceptance criteria and studies which are not relevant to this 510(k) submission for a non-AI medical device. Therefore, the following points cannot be addressed from the given document:
- Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI device relying on interpreted data.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Clinical Testing:
The document explicitly states: "No clinical testing was performed in association with this submission." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to an existing predicate device.
Ask a specific question about this device
(308 days)
The Compressyn™ Band is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
The Compressyn™ Band System consists of a stainless steel coupler preloaded with a polyester fiber band. It is a cerclage fixation device that is placed around or through the sternum and locked in place to provide stabilized fixation.
The acceptance criteria and study proving the device meets them are summarized below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Sternal compression | Not explicitly stated; device found substantially equivalent to predicates. |
| Static performance to a 5mm gap | Not explicitly stated; device found substantially equivalent to predicates. |
| Static performance to point of failure | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to a 5mm gap | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to point of failure | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to 2000 cycles | Not explicitly stated; device found substantially equivalent to predicates. |
Note: The document states, "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate devices." Specific numerical acceptance criteria and the Compressyn™ Band's performance against them are not provided, only that the outcome met the substantial equivalence criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set (number of devices tested) or the data provenance (country of origin, retrospective/prospective). It only mentions that "All necessary verification and validation testing has been performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would require expert-established ground truth. The testing involves mechanical and performance characteristics.
4. Adjudication Method for the Test Set
N/A. The testing described is performance-based (mechanical tests) typically without human adjudication in the context of diagnostic agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" or reference for comparison appears to be the performance characteristics of the predicate devices. The study aimed to demonstrate "substantial equivalence" of the Compressyn™ Band's mechanical and physical performance to these predicate devices. The specific physical properties or failure points of the predicate devices would form the benchmark for comparison.
8. The Sample Size for the Training Set
N/A. This is not an AI/machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As there is no training set for an AI model, this question is not applicable.
Ask a specific question about this device
Page 1 of 1