(308 days)
Chromic Gut surgical sutures are indicated for use as absorbable sutures in gegeral soft tissue approximation and/or ligation, including use in ophthalmic procedures, out NOT for use in cardiovascular and neural tissue.
Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft Catgut plain surgical sutures are indicated of assessments of the subscribed on the researces, but NOT tissue approximation and neural tissue.
Polyglycolic acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neurological tissues.
Silk sutures are indicated for use as non-absorbable sutures in general soft tissues Silk sutures are indicated for use as non-acolorodolorouse in cardiovascular, ophthalmic, neural tissue.
Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue r oreximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue rylon battleoo and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Polyproylene sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
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This documentation is a 510(k) premarket notification for various types of surgical sutures and needles. The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device. This process does not involve establishing new acceptance criteria or conducting studies to demonstrate the device meets new performance standards in the same way a PMA (Premarket Approval) would.
Instead, the "study" demonstrating the device meets "acceptance criteria" in this context is the submission and review of information to establish substantial equivalence to a predicate device. The "acceptance criteria" are not reported device performance metrics against specific targets, but rather the FDA's regulatory requirements for demonstrating this substantial equivalence.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations inherent in a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are typically demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety and effectiveness. There isn't a table of quantitative performance metrics with "reported device performance" against explicit thresholds in the way a PMA clinical trial would present.
Instead, the performance is implicitly compared to the predicate device's established safety and effectiveness. The document lists the general indications for use for each suture type, which functionally serve as the "performance" demonstrated to be equivalent to the predicate.
| Suture Type | Indication For Use (Functionally "Device Performance") | "Acceptance Criteria" (Implicit for 510(k)) |
|---|---|---|
| K982646 Ailee Sutures and Ailee Needles (General) | General soft tissue approximation and/or ligation. | Substantial equivalence to legally marketed predicate devices. |
| Chromic Gut | Absorbable sutures in general soft tissue approximation and/or ligation, including ophthalmic procedures, but NOT for cardiovascular and neural tissue. | Substantial equivalence to legally marketed predicate (Chromic Gut) predicate devices for these indications. |
| Catgut plain | Absorbable sutures in general soft tissue approximation, but NOT for cardiovascular and neural tissue. (Minor wording differences from Chromic Gut but similar intent). | Substantial equivalence to legally marketed (Catgut Plain) predicate devices for these indications. |
| Polyglycolic acid sutures | Absorbable sutures in general soft tissue approximation and/or ligation, including ophthalmic procedures, but NOT for cardiovascular and neurological tissues. | Substantial equivalence to legally marketed (Polyglycolic acid) predicate devices for these indications. |
| Silk sutures | Non-absorbable sutures in general soft tissues, but NOT for cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Silk) predicate devices for these indications. |
| Polyester sutures | Non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Polyester) predicate devices for these indications. |
| Nylon sutures | Non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Nylon) predicate devices for these indications. |
| Polypropylene sutures | Non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Polypropylene) predicate devices for these indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document, being an FDA 510(k) clearance letter, does not contain details about specific test sets, sample sizes, or data provenance from studies. A 510(k) submission primarily relies on comparisons to predicate devices and potentially presents bench testing or material characterization data to support substantial equivalence. It is not a clinical trial report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a 510(k) submission in the way you're describing for, for example, a diagnostic AI. The "ground truth" here is the prior regulatory clearance and established safety/effectiveness of the predicate devices. The experts involved are FDA reviewers (e.g., those in the Division of Surgical, Orthopedic and Restorative Devices) who evaluate the submitted information against regulatory standards. Their qualifications are their expertise in medical device regulation and the relevant medical fields.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There isn't a "test set" and a process of adjudicating findings from it in the context of this 510(k) clearance letter.
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 surgical sutures and needles, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a 510(k) is the legally marketed predicate device. The manufacturer demonstrated that their Ailee Sutures and Needles are "substantially equivalent" to existing, cleared sutures and needles. This equivalence is established through comparison of:
- Intended use
- Technological characteristics (e.g., material composition, dimensions, sterilization method, mechanical properties)
- Performance data (e.g., tensile strength, knot security, absorption profile for absorbable sutures, biocompatibility, sterility) to show they are at least as safe and effective as the predicate device, or that any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI device.
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.