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510(k) Data Aggregation
(55 days)
Arcuro Medical Ltd.
The SuperBall-RC™ System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures.
The SuperBall-RC™ System is indicated for use in rotator cuff repair procedures.
The SuperBall-RC™ System is an all-inside, all-suture repair device. Each device includes two non-absorbable, soft suture bundles that are attached to each other (USP 1 UHMWPE) and preloaded within a needle delivery system along with the SuperBall securing element made of a braided, coreless sack. The adjustable depth delivery system insertion needle angles), enables the positioning and subsequent deployment of the two bundles under/within the soft tissue. Once placed, manipulation of the delivery system's the pulling suture (USP 3-0 Polyester Cottony II Green), thereby approximating the positioned bundles. The tightened implant is secured by the SuperBall is passed to nestle beside the deployed bundles. By pulling the SuperBall Actuating suture (USP 2-0 Polyester Tevdek II Green), a ball is formed, securing the implant in position.
This document is an FDA 510(k) clearance letter and 510(k) summary for the SuperBall-RC™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way that an AI/ML medical device would.
The document discusses the mechanical strength (shear pullout testing) and usability of the device, but these are general engineering and user experience validations, not a study against specific, quantified acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) typically seen for AI/ML devices.
Therefore, it's not possible to extract the requested information (like a table of acceptance criteria, sample size for test/training sets, number of experts for ground truth, MRMC study results, etc.) from this document. This device is a physical surgical implant, not an AI/ML diagnostic or therapeutic software.
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(262 days)
Arcuro Medical Ltd.
The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.
The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System(s) is a suture retention device comprised of two non-absorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. The SuperBall System is provided sterile for single use only.
The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene. The system allows for repair procedures in the lateral and medial meniscus, located within the outer 2/3 region of the meniscal zone (i.e., medial and posterior).
This is not an AI/ML device, therefore the requested information regarding AI/ML device performance and study design is not applicable.
Device Name: SuperBall™ "18º-Up", "24º-Up" and "12º-Reverse" Meniscal Repair System
Device Description:
The SuperBall™ 18ºUp, "24ºUp" and "12ºReverse" Meniscal Repair System(s) is a suture retention device comprised of two non-absorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. The SuperBall System is provided sterile for single use only. The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene.
Indications for Use:
The SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.
Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Evaluation | Verification of sequential operation per IFU and proposed mode of operation. Tests confirmed the device operates as intended throughout routine, sequential operation resulting in deployment of the SuperBall implant in a meniscal simulating material. |
| Evaluation of Deployment Force | Force characterization tests determined the forces applied to the system throughout sequential operation. Each operating step was evaluated using a designated force measuring gauge suitable for the applied force. Results indicate appropriate force profile for operation. |
| Suture Knot-Pull (in accordance with USP-881 – Tensile Strength) | Demonstrated compliance with the required limits on average knot-pull tensile strength for the suture strands in the implant. |
| Implant and Suture Detachment Force (in accordance with USP-871 – Suture Needle Attachment) | Demonstrated compliance with the required limits on Needle Attachment for the suture strands comprising the SuperBall implant. |
| Implant Pullout Force following Cyclic Load | Demonstrated that the device can withstand cyclical tensile forces and maintain a minimal displacement, comparable to the predicate device under identical loading conditions. |
| Corrosion Resistance (in accordance with ISO 10555-1:2013, Intravascular catheters - Sterile and single-use catheters, Annex A) | Demonstrated that the devices' stainless steel components are corrosion resistant. |
| Bond Strength | Bonded components detachment tests verified that the bonded elements of the subject device(s) delivery system(s) can withstand forces greater than those that may be experienced during clinical use and as derived from the functional evaluations. |
| Shelf-Life Stability (following 2-year shelf-life period) | Validation processes conducted indicated qualified the subject devices' stability throughout transportation and shelf life (storage), verifying that the system complies with predefined specifications and acceptance criteria following a shelf-life period of 2 years (24 months). |
Study Information (Not Applicable for this type of device submission as it is not an AI/ML device):
- Sample size used for the test set and the data provenance: Not applicable. Performance testing was conducted on physical devices and simulating materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance is based on established engineering and material science standards and physical measurements, not expert human interpretation.
- Adjudication method (e.g., 2+1, 3+1, none) 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. 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. Ground truth for this device's performance is based on engineering specifications, material properties, and standardized mechanical test results.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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(133 days)
Arcuro Medical Ltd.
The SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.
The SuperBall Meniscal Repair System is a suture retention device comprised of two nonabsorbable, soft suture implants along with a SuperBall securing element preloaded within a curved needle delivery system. More specifically, the device consists of suture bundles, a mesh stitch, actuator suture, pulling suture, and SuperBall securing element. The SuperBall implants and sutures are composed of polyester and ultra-high molecular weight polyethylene. The system allows for repair procedures in the lateral and medial meniscus, located within the outer 2/3 region of the meniscal zone (i.e., medial and posterior). The structure of the SuperBall is a self-locking structure enabling the SuperBall securing element to remain in its collapsed position. The SuperBall remains secure as the braided component (Mesh) is collapsed from within by pulling the Actuator Suture. The SuperBall System is provided sterile for single use only.
The provided text is a 510(k) summary for the Arcuro Medical Ltd.'s SuperBall Meniscal Repair System, which is a medical device. This document describes the device, its intended use, and various tests performed to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a list with pass/fail thresholds. Instead, it describes performance tests and states that the device "demonstrated compliance," "performs as intended," or "confirm that the SuperBall has appropriate strength."
| Test Category | Reported Device Performance |
|---|---|
| Verification of dimensional attributes | Confirmed that the device performs as intended. |
| Functional evaluation | Confirmed that the device performs as intended. |
| Deployment force | Confirmed that the device performs as intended. |
| Suture knot pull-out | Conducted in accordance with USP-881 - Tensile Strength. Results "demonstrated compliance with the required limits on average knot-pull tensile strength." |
| Implant and suture detachment force | Conducted in accordance with USP-871 - Suture Needle Attachment. Results "demonstrated compliance with the required limits on Needle Attachment." In all instances, the results demonstrated the biocompatibility of the SuperBall implants and delivery system. |
| Implant pullout force | Confirmed that the device performs as intended. |
| Cyclic load | Confirmed that the device performs as intended. |
| Corrosion resistance | Conducted in accordance with ISO 10555-1:2013, Annex A. Results "demonstrated that the devices' stainless steel components are corrosion resistant." |
| Bond strength | Confirmed that the device performs as intended. |
| Biocompatibility | Conducted in accordance with ISO 10993-1:2009 for components that come in direct contact with the patient's body. Results "demonstrated the biocompatibility of the SuperBall implants and delivery system." |
| Sterilization | "Validated EtO sterilization cycle" per ISO11135:2014. Residual levels of Ethylene Oxide (EtO) and Ethylene Chlorohydrin (EC) maintained in compliance with ANSI/AAMI/ISO 10993-7: 2008(R) 2012. |
| Usability | Evaluated by surgeons. Users reported that the device "was easy to use and no use related risks were reported." |
| Shelf-life | Package and device stability evaluations "performed to support the proposed shelf life." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for most bench tests. For the usability study, "A total of eight surgeons evaluated the usability of the device, with six surgeons evaluating use of the final finished configuration of the device."
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. All studies described are bench tests or usability evaluations, not clinical trials on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question does not directly apply as the studies are primarily bench testing and a usability evaluation. There is no "ground truth" in the sense of a medical diagnosis being established by experts against which the device's diagnostic performance is compared.
- Usability Study: "A total of eight surgeons" evaluated the device. Their specific qualifications (e.g., years of experience, specialty beyond "surgeon") are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The described studies are bench tests and a usability evaluation, not studies requiring adjudication of diagnostic outcomes.
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
Not applicable. This device is a surgical repair system, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted.
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, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted in point 3, the studies are focused on the physical and functional performance of the device (bench tests) and its ease of use by surgeons (usability study), not diagnostic accuracy against a ground truth.
8. The sample size for the training set
Not applicable. This document is about a manufactured medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted in point 8, there is no AI algorithm training set.
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