(140 days)
PDO surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery other than contact with comea and/or sclera. PDO Suture is not intended for use in adult cardiovascular tissue, microsurgery or neural tissue.
PGA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
Fast Absorbing PGA (Trade Name: Vilet Quick): Vilet Quick surgical suture is indicated for use in general soft tissue approximation, including use in ophthalmic procedures, where only short-term wound support is required. Vilet Quick is not intended for use in cardiovascular or neurological procedures.
PGCL: PGCL surgical suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
Riverpoint Medical Absorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. They are composed of the applicable suture material and a standard medical grade suture needle as applicable (sutures can be provided without needles as well).
Available Suture sizes will be standard according to USP 32 requirements (12/0 through 7, depending on suture type).
The provided document describes the 510(k) summary for Riverpoint Medical's absorbable surgical sutures (PGCL, PGA, Fast Absorbing PGA, PDO). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The document does not provide a table of acceptance criteria with specific numeric targets for metrics (e.g., sensitivity, specificity, accuracy) or reported performance data in those terms. Instead, the acceptance criteria are implicitly and explicitly defined by:
- Substantial Equivalence: The primary "acceptance criterion" is that each variety of Riverpoint Medical absorbable suture must be substantially equivalent to its respective predicate device. This means it performs as safely and effectively as a legally marketed device.
- USP 32 Requirements: The device must meet the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32 (United States Pharmacopeia 32). This is an explicit acceptance criterion.
- Biocompatibility: The materials used must meet known biocompatibility standards (per ISO 10993). This includes specific tests like Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity (Bacterial Reverse Mutation and Chromosomal Aberration, Bone Marrow Micronucleus), Subchronic Toxicity, and Muscle Implantation. The document states that these tests were performed and implies successful completion, thus acting as acceptance criteria.
No standalone performance metrics like sensitivity, specificity, or AUC are reported since this is a medical device (suture) and not an AI/diagnostic algorithm. The performance is assessed against established material and mechanical standards, and against the safety and effectiveness of predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an algorithm. For the physical testing (USP 32 requirements, biocompatibility), the document states that "Testing is performed on each lot of product to verify that USP requirements have been met prior to release." This implies a continuous quality control process rather than a one-time test set. The number of samples per lot for these tests is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data for an AI algorithm. The "data" here are physical and biological test results on the suture materials themselves.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable: This information is not relevant to a medical device like a surgical suture. Ground truth, in this context, refers to established scientific and regulatory standards (USP 32, ISO 10993) and the performance of predicate devices, not expert human assessment of images or clinical cases.
4. Adjudication Method:
- Not Applicable: There is no adjudication method described as there are no human readers or expert panels involved in "adjudicating" the device's performance in the way an AI algorithm's output might be reviewed. Compliance is assessed against predefined standards and testing protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable: An MRMC comparative effectiveness study is designed for diagnostic systems, particularly those involving human interpretation of data (e.g., radiologists reading images) where AI assistance might improve performance. This is a surgical suture, a physical medical device. The "effectiveness" is shown through meeting material science standards and demonstrating substantial equivalence to already approved predicate devices.
7. Type of Ground Truth Used:
- Regulatory Standards and Physical/Biological Testing: The ground truth for this device's acceptance is based on:
- USP 32: United States Pharmacopeia standards for surgical sutures regarding physical properties like diameter, tensile strength, and needle attachment strength.
- ISO 10993: International Organization for Standardization standards for biological evaluation of medical devices (biocompatibility).
- Predicate Device Performance: The established safety and effectiveness profiles of the identified predicate devices (K061037, K972566, K023710, K960653). The new devices are considered safe and effective if they are substantially equivalent to these predicates.
8. Sample Size for the Training Set:
- Not Applicable: This is not an AI/machine learning device. There is no concept of a "training set" for the surgical suture itself. The "training" data, if one were to extend the metaphor loosely, are the historical data, scientific understanding, and manufacturing processes accumulated over time that allow for the creation of materials meeting specific regulatory and performance criteria.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no training set in the AI context, this question is not relevant. The "ground truth" for the device's design and manufacturing is derived from the long-standing scientific and regulatory principles governing medical device development, material science, and prior art represented by predicate devices.
§ 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.