(287 days)
The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.
Y. JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2.
The Y. JACOBS YOUNG'S THREAD will be available in single use packages, sterile after ethylene oxide (EO) gas sterilization. It degrades and dissolves over time in tissue.
Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon.
Y. JACOBS YOUNG'S THREAD consists of:
- absorbable polydioxanone (PDO) suture
The provided text describes a 510(k) premarket notification for the "Y. JACOBS YOUNG'S THREAD," an absorbable polydioxanone surgical suture. The document attests to the substantial equivalence of the device to legally marketed predicate devices, rather than detailing a study against specific acceptance criteria for performance in a clinical setting in the way one might for an AI/ML device.
Here's an analysis based on the information provided, focusing on how a medical device's "acceptance criteria" are typically met in a 510(k) submission, particularly for an absorbable suture:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a surgical suture, "acceptance criteria" are generally tied to demonstrating equivalence to predicate devices across various material and mechanical properties, as well as biocompability and sterilization. The document lists the types of performance tests conducted.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Performance (Summary from Document) |
|---|---|---|
| Biocompatibility | Biocompatibility testing | Confirmed (implied by "Performance Data" and "Summary of Substantial Equivalence") |
| Sterilization | Sterilization testing | Sterile after ethylene oxide (EO) gas sterilization (stated) |
| Shelf-Life | Shelf-life testing | Confirmed (implied by "Performance Data" and "Summary of Substantial Equivalence") |
| Physical/Mechanical Properties | Characterization testing of the suture design, tensile strength, strength retention (biodegradability), straight-pull, barb holding force, degradation profile | Demonstrated to be "as substantially equivalent... as the legally marketed predicate devices." The subject and predicate devices have "nearly identical technological characteristics" and "minor differences do not affect substantial equivalence." Specific results (e.g., actual tensile strength values) are not provided in this summary but would have been part of the full 510(k) submission. |
| Material Composition | - | Same material composition (PDO and dye) as predicate K080985 and K130191. |
| Design | - | Similar design with respect to the barbs for fixating to tissue as all predicates. |
| Endotoxin Content | LAL (endotoxin) testing | Confirmed (implied by "Performance Data" and "Summary of Substantial Equivalence") |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each of the performance tests (e.g., number of sutures tested for tensile strength). It mentions "characterization testing of the suture design," "tensile strength," "strength retention (biodegradability)," "straight-pull," "barb holding force," "degradation profile," "biocompatibility," and "LAL (endotoxin)."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) for a physical medical device (suture), the performance data would typically be derived from in vitro (laboratory) and in vivo (animal, if applicable, or simulation) testing conducted under controlled conditions, often by the manufacturer or authorized testing labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not relevant for the technical performance testing of a surgical suture in a 510(k) submission. The "ground truth" for suture performance is established by standardized testing methods and international standards (e.g., ASTM, ISO standards for surgical sutures).
- For Biocompatibility: The "ground truth" is adherence to ISO 10993 series standards, assessed by toxicologists and other experts in the field.
- For Mechanical Testing: The "ground truth" is defined by the test method and equipment calibration, with results analyzed by engineers and materials scientists.
4. Adjudication Method for the Test Set
Not applicable in the context of physical and material performance testing for a suture. Test results are objectively measured and compared against predefined specifications or predicate device data, not subject to expert adjudication in the same way clinical image interpretation might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used to evaluate the diagnostic or prognostic performance of imaging devices, AI algorithms, or other tools where human interpretation plays a significant role. This submission pertains to a physical surgical suture.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical surgical suture, not an algorithm. Its performance is inherent in its material properties and design, used by a surgeon (human-in-the-loop, but not assisted by this specific device in a way that requires AI/ML evaluation).
7. Type of Ground Truth Used
The ground truth used for the performance evaluation of this surgical suture would be based on:
- Standardized Test Methods and Specifications: Adherence to established industry standards (e.g., for tensile strength, degradation rates, barb holding force).
- Predicate Device Data: The performance of the predicate devices (Quill™ Self-Retaining System and MINT™) serves as the benchmark for demonstrating substantial equivalence.
- Biocompatibility Standards: ISO 10993 series for biological evaluation of medical devices.
- Sterility Assurance Levels (SAL): Defined by sterilization standards.
8. Sample Size for the Training Set
Not applicable. The Y. JACOBS YOUNG'S THREAD is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on a design and tested to ensure it meets specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI/ML algorithm, this question is irrelevant to this device submission. The "ground truth" for manufacturing a suture is the design specification and quality control processes.
Summary of the Study that Proves the Device Meets Acceptance Criteria for a 510(k) Submission:
The provided document describes the basis for a 510(k) clearance, which is demonstrating substantial equivalence to existing legally marketed predicate devices. The "study" here is a series of in vitro and potentially in vivo (non-human) engineering and material science tests.
- Device: Y. JACOBS YOUNG'S THREAD (absorbable polydioxanone surgical suture with barbs).
- Predicate Devices:
- Design: Monofilament PDO suture with uni-directional barbs, dyed with D&C Violet No.2, sterilized by ethylene oxide.
- Intended Use: Soft tissue approximation where an absorbable suture is appropriate.
- Performance Tests Conducted: Biocompatibility, sterilization, shelf-life, characterization testing of suture design, tensile strength, strength retention (biodegradability), straight-pull, barb holding force, degradation profile, and LAL (endotoxin).
- Conclusion of the Study (as stated in the document): "Based on the comparison, as well as the information provided in the SE Comparison Table... supported by data found in Sections 11, 14, 15 and 18, we have demonstrated that the Y. JACOBS YOUNG'S THREAD has been shown to be as substantially equivalent for the proposed Intended and Indications for Use as the legally marketed predicate devices."
The entire submission package to the FDA, including the detailed reports of these tests (Sections 11, 14, 15, and 18, which are not provided here), constitutes the "study" demonstrating that the device meets the criteria for substantial equivalence, and thus, "acceptance." The acceptance criteria are, in essence, meeting or exceeding the performance characteristics of the identified predicate devices in relevant tests.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.