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AlloX2 Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.

Additionally, the AlloX2 Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does nort-term, immediate, intraoperatively placed drains.

The AlloX2 Tissue Expanders are constructed as a unit from silicone elastomer and consist of a smooth or textured expansion envelope with an integral magnetic injection port. Specialty Surgical Products is proposing that an integral or remote (connected by tubing) drain port be integrated into the predicate device to facilitate the drainage of fluid in the periprosthetic pocket. The port design and magnetic technology/concept are the same as those of the predicate injection ports. The principles of operation of the subject device methodology are identical to that of the primary predicate Silicone Tissue Expander and the additional predicate Closed Wound Drain.

This document is a 510(k) premarket notification for a medical device called "AlloX2 Tissue Expanders." It doesn't describe an AI/ML-driven medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the physical and functional characteristics of the tissue expanders and compares them to existing predicate devices to demonstrate substantial equivalence for FDA clearance.

Therefore, I cannot provide the information requested in the prompt, as it is designed for studies proving the performance of AI/ML diagnostic devices. The document concerns a physical medical device (tissue expanders) and its mechanical/material performance, not a diagnostic algorithm.

Specifically, the document does not include:

• Acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC).
• A test set, training set, or data provenance in the context of an AI/ML model.
• Expert involvement for establishing ground truth for diagnostic images.
• Adjudication methods for diagnostic interpretations.
• Multi-reader multi-case (MRMC) studies or effect sizes of AI assistance on human readers.
• Standalone algorithm performance.
• Ground truth based on expert consensus, pathology, or outcomes data for diagnostic accuracy.

The "testing" mentioned in the document refers to engineering specifications and mechanical/material performance tests for the physical device (e.g., tube shell junction, overexpansion, strength), aligning with ASTM F1441-03, a standard for soft-tissue expander devices.

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The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

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This document is a 510(k) clearance letter for a device called "Mammary Sizer." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.

Virilis Penile Prostheses

I am sorry, but the provided text is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study that proves the device meets acceptance criteria.

The document states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This process confirms that the new device is as safe and effective as a legally marketed device; it does not involve a study to demonstrate performance against specific acceptance criteria in the way a clinical trial or performance study would.

Therefore, I cannot provide the requested information based on the input text.

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The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

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The provided text is a 510(k) clearance letter from the FDA to Specialty Surgical Products, Inc. for their Mammary Sizer device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a notification of substantial equivalence for a medical device and thus does not describe the technical details of the device's validation. It primarily focuses on regulatory aspects and the device's classification.

Therefore, I cannot provide the requested information based on the input text.

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Specialty Surgical Products Sterile Silicone Wound Covers are intended for external use in short term applications related to wound treatment by temporarily covering traumatic areas where primary closure attempts must be abandoned in favor of a staged repair.

Sterile Silicone External Wound Covers

This document is a 510(k) clearance letter from the FDA for a medical device called "Sterile Silicone External Wound Covers". It does not contain information about the acceptance criteria or results of a study as typically found in a clinical trial report or a performance study summary.

Therefore, I cannot provide the requested information. This document primarily focuses on the regulatory clearance of a device based on substantial equivalence, rather than detailed performance study data.

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Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

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The provided text is a U.S. FDA 510(k) clearance letter for a "Magnetic Port Silicone Tissue Expander." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided text. The document is about regulatory approval, not a performance study report.

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Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term applications for use are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For longterm application the indications for use are: for nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair of omphalocele, for lengthening extraocular muscles in select cases of strabismus, as a protective sheathing to help facilitate neural regeneration and tendon anastomosis, as a protective sheathing to help facilitate osteogenesis, guided tissue regeneration between teeth and gingival margin, or external ear canal for example

Silicone Elastomer Sheeting

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for testing or training, data provenance, expert participation, adjudication methods, or comparative effectiveness studies.

The document is a 510(k) clearance letter from the FDA for a device called "Silicone Elastomer Sheeting." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its approved indications for use.

Such a clearance letter generally does not contain the detailed study results and acceptance criteria that would be submitted to the FDA during the 510(k) application process. This document is the FDA's decision, not the applicant's submission.

Therefore, I cannot populate the table or answer the specific questions you've posed about the study and acceptance criteria based solely on the provided text.

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The Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

Silicone Blocks

The provided document is an FDA 510(k) clearance letter for "Silicone Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or details typically found in a clinical study report.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. This document is a regulatory communication, not a performance study report.

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Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

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I am sorry, but based on the provided document, I cannot extract the information required to answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Rollicone Tissue Expander/Inflatable Tissue Expander." This type of document confirms that the device is substantially equivalent to legally marketed predicate devices and is allowed to be marketed.

However, it does not contain information about:

• Specific acceptance criteria for device performance.
• Results of a study proving the device meets acceptance criteria.
• Details about sample sizes, data provenance, expert qualifications, ground truth establishment, or statistical study designs (MRMC, standalone).

The document's purpose is regulatory clearance, not a detailed technical report of device validation studies.

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The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Disposable Sillicone Epistaxis Catheter

I am sorry, but without further information about the device and its performance, I cannot provide a detailed answer to your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Disposable Silicone Epistaxis Catheter." It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not contain any information about:

• Acceptance criteria for performance.
• Reported device performance data.
• Study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details).

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data and study design.

If you can provide a document that contains this information, I would be happy to help you extract and present it according to your requested format.

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