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The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.

The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a barbed suture manufactured from #1 USP nylon monofilament. The polyester sheath is coated with beeswax.

The provided document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex SoftStitch device. It pertains to a surgical suture and implantable retention device, not an AI-powered diagnostic tool. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance metrics, ground truth, expert adjudication, or MRMC studies is not applicable and cannot be extracted from this document.

The document details the substantial equivalence of the modified Arthrex SoftStitch to a previously cleared predicate device (K190707) and a reference device (K203117). The performance data cited focuses on mechanical strength (tensile testing) and biocompatibility (bacterial endotoxin testing), which are standard for medical devices like sutures, but not relevant to AI/ML device performance.

Therefore, I cannot fulfill the request as the provided text does not contain information about the development and validation of an AI-powered medical device.

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The Arthrex SoftStitch is an implantable suture which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears. The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a wax coated barbed suture manufactured from nylon monofilament.

The provided text does not describe an AI/ML device, and therefore the complete information requested in the prompt cannot be extracted. The document is a 510(k) premarket notification for a medical device called "Arthrex SoftStitch," which is an implantable suture retention device. This type of device falls under traditional medical device regulations and does not involve AI or machine learning.

Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set" are not applicable.

Here's the information that can be extracted related to acceptance criteria and performance studies, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document describes performance testing conducted to demonstrate substantial equivalence to predicate devices rather than specific quantitative acceptance criteria with reported numerical performance values in a direct comparison. The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices through various tests.

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for each test. For the "canine functional meniscus implant study," the sample size (number of animals) is not provided.
• Data Provenance:
  • Cyclic pull-out testing: Laboratory testing.
  • Canine functional meniscus implant study: Animal model (canine). No country of origin is specified.
  • Biocompatibility testing: Laboratory testing.
  • Bacterial Endotoxin testing: Laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device clearance, not an AI/ML diagnostic or prognostic device study that requires expert ground truth establishment for a test set. The "truth" is established through engineering and biocompatibility testing, and animal studies.

4. Adjudication method for the test set

Not applicable. This is a medical device clearance, not an AI/ML study involving human readers or interpretation requiring adjudication.

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 not an AI-assisted diagnostic or prognostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through:

• Direct physical and mechanical testing: "Cyclic pull-out testing."
• Biocompatibility testing: According to ISO 10993-1:2018 standards.
• In vivo animal studies: "Arthroscopic/histologic imaging from a canine functional meniscus implant study."
• Materia characterization and manufacturing controls: Assessment of product attributes, manufacturing conditions, packaging, sterilization, and shelf-life.
• Pyrogenicity testing: Bacterial endotoxin testing.

8. The sample size for the training set

Not applicable. This is a medical device clearance, not an AI/ML device that uses training sets.

9. How the ground truth for the training set was established

Not applicable. No training set is used for this type of device.

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