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Autosuture™ Protack: The Auto Suture™ Protack™ 5mm instrument has application in endoscopic surgery procedures for fixation of prosthetic material and approximation of tissue in various surgical specialties, such as the repair of hernial defects.

Autosuture™ TACKER™ System: The Auto Suture™ TACKER™ System is indicated to affix prosthetic material or approximate tissue in a variety of endoscopic or other surgical procedures.

Absorbatack™ Absorbable Fixation Devices: The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.

Autosuture™ Protack™: The Autosuture™ Protack 5 mm instrument contains 30 titanium helical fasteners. The diameter of the fastener measures approximately 4 mm and the length is approximately 3.8 mm. The instrument is designed for introduction and use through an appropriately sized trocar sleeve or larger with the use of a converter. The overall length of the shaft is approximately 35.5 cm.

Autosuture™ TACKER™ System: The Autosuture™ TACKER™ System is packaged in 4 different product configurations as specified on the product package. The Autosuture™ TACKER™ System contains the following products: The Autosuture™ TACKER™ delivery device, which contains 20 titanium helical fasteners and is designed to be used with the Autosuture™ TACKER™ reusable handle. The Autosuture™ TACKER™ reusable handle is packaged sterile and may be resterilized four (4) times for a total of five (5) uses. The Autosuture™ STAT TACK™ single use instrument is designed to deliver 15 helical fasteners. The helical fastener size is approximately 3.9 mm in diameter by 4 mm long.

Autosuture™ Absorbatack™ Absorbable Fixation Devices: The Absorbatack™ Absorbable Fixation Device is a sterile single use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack is constructed of an ausorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with 5, 10, or 20 absorbable tacks.

This 510(k) summary for the Autosuture™ Protack, Autosuture™ TACKER™ System, and Absorbatack™ Absorbable Fixation Devices states that no performance testing was conducted for this specific 510(k) submission (K090470). The submission is a "Changes Being Effected" amendment where only contraindications are being added, and the devices themselves are stated to be identical to their predicate devices.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from the provided text for this specific submission. The document explicitly states:

"PERFORMANCE DATA: There have been no changes to the Autosuture™ Protack, Autosufure™ TACKER™ System, Absorbatack™ Absorbable Fixation Devices. TACKER™ Performance testing is not applicable to this 510(k) - Changes Being Effected, since only contraindications are being added."

This means that for K090470, the device's performance was not re-evaluated as it was considered to be unchanged from previously cleared predicate devices. The substantial equivalence relies on the performance data of those predicate devices. Without access to the predicate device 510(k) summaries (K963999, K944415, and K071920), we cannot provide the details of acceptance criteria or performance studies.

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