(563 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to predicate devices (K132043 & K073149) regarding: | - Demonstrates substantial equivalence to predicate devices. |
| - Basic design features | - Basic design features are described as identical or comparable. |
| - Intended use | - Identical intended use. |
| - Fundamental scientific technology | - Identical fundamental scientific technology. |
| - Sterility, packaging, shelf-life | - Assessment determined no additional risks/concerns. |
| Biocompatibility (ISO 10993-1:2018) | - Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing conducted. |
| Physical/Mechanical Performance (Cyclic Pull-out) | - Cyclic pull-out testing performed to demonstrate substantial equivalence. |
| In Vivo Performance | - Arthroscopic/histologic imaging from a canine functional meniscus implant study performed to demonstrate substantial equivalence. |
| Pyrogenicity (EP 2.6.14/USP ) | - Bacterial endotoxin testing conducted; device meets pyrogen limit specifications. |
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.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.