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Duramesh™ Mesh Suture is indicated for general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy where the bowel is not entered. Duramesh™ is not for use in the skin and other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures.

DURAMESH™ is a polyfilament, synthetic, non-absorbable, sterile surgical suture composed of isotactic polypropylene polymer of high molecular weight. The suture is provided dyed (blue) and is uniform in appearance. The blue dye pigment is Phthalocyaninato (2-) Copper. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical suture, except for diameter.

DURAMESH™ is passed on either side of tissues using an attached swaged needle as an introducing agent and tied to itself with at least two knots composed of two throws each to maintain tension.

DURAMESH™ is supplied sterile and is available with two needle configurations (small and large) in four USP sizes (2-0 through 2), each with a length of approximately 36 inches (91 cm). Each box contains one DURAMESH™ housed in a Tyvek envelope within which the DURAMESH™ is packaged in a sterile protective medical grade tube fixed to a sterile card.

The provided text does not describe an AI/ML medical device, but rather a surgical suture (DURAMESH™ Mesh Suture). Therefore, the concepts of acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC), sample size for test/training sets in an AI/ML context, number of experts for ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/ML are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the DURAMESH™ Mesh Suture to a predicate device based on material, design, performance, and biological safety. The "acceptance criteria" here refer to the product's ability to meet medical device standards and show equivalence to a predicate, not AI/ML model performance metrics.

Specifically, the "Bench Data" section on page 6 mentions some performance criteria for the suture:

• Needle attachment strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 <871> Sutures - Needle Attachment.
• Tensile strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 <881> Sutures - Tensile Strength. It also meets USP requirements under simulated surgical deployment, cycle loading, and dynamic loading.
• Knot Size and Knot Strength: DURAMESH™ knots were stronger than predicate knots for the same number of throws. Knot security is achieved with 4 throws as per labeling.
• Diameter: Diameter decreases with increasing axial load.
• "Stripped" samples: Maintain adequate tensile strength to satisfy USP requirements.

The document also describes:

• Biocompatibility testing: Per ISO 10993-1, ISO 14971, and 2020 FDA Biocompatibility Guidance, showing biocompatibility based on various tests (cytotoxicity, sensitization, etc.).
• Packaging testing: According to ASTM D4169-16 and ASTM F1929-15.
• Sterilization: Ethylene Oxide sterilization following AAMI TIR28:2016 and ISO 11135:2014, meeting ISO 10993-7: 2008 limits for residuals.
• Shelf-Life: Accelerated and real-time aging stability testing supports a 5-year shelf life with no loss of tensile strength.
• Animal Data: Two large-animal porcine implantation studies (1- and 3-month) assessed adverse tissue reaction and dehiscence. Outcomes showed successful closure, tissue ingrowth, and slight irritation compared to standard polypropylene suture.
• Clinical Data: A single-investigator clinical trial with 53 patients (80 surgical sites).
  • Primary outcome: Surgical site occurrence (SSO). No early or late SSO observed.
  • Secondary outcomes: Device-related rehospitalization, return to OR, and wounds. No such events occurred.
  • Long-term assessment (12-month): 15 subjects compared to 11 patients with standard sutures, showing equivalent or slightly improved outcomes with DURAMESH™.

Given this context, I cannot generate a response that directly addresses the prompt's specific requirements for AI/ML device acceptance criteria and study design, as the provided document is not about an AI/ML device.

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The SPI Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

SPI Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. Both straight and angled abutments are available.

The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

This is an FDA 510(k) summary for a medical device (SPI Dental Implant System), not a study report for an AI/ML powered device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance.

The document describes standard engineering and biocompatibility testing for a dental implant, confirming its substantial equivalence to a predicate device. It includes:

• Testing Summary:
  • Dynamic fatigue testing according to ISO 14801
  • Surface analysis (SEM and EDS)
  • Sterilization according to ISO 11137-1 and 11137-2 (implants), ISO 17665-1 and ISO 17665-2 (abutments)
  • Package integrity testing according to ASTM F1929-12
  • Accelerated aging according to ASTM F1980-07
  • Material compliance with ASTM F136
  • Biocompatibility (cytotoxicity) according to ISO 10993-5
  • Endotoxin testing according to USP 161

These tests are designed to demonstrate the physical, chemical, and biological safety and performance of the dental implant itself, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document does not pertain to an AI/ML device.

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Rigid Endoscopes

MSI MedServ International Deutschland GmbH rigid endoscopes and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals.

A rigid endoscope is a tubular endoscopic device with any of a group of accessory devices which attach to the endoscope and is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals. It is typically used with a Fiberoptic light source and carrier to provide illumination.

This is not an AI/ML device and therefore the requested information is not applicable.

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Ask a specific question about this device