(23 days)
MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.
MITSU suture is intended for use in general soft tissue approximation including use in ophthalmic procedures, but not for use in cardiovascular or neurological tissues.
MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.
FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
MEGASORB™ suture is a synthetic absorbable sterile surgical suture composed of Polyglycolic Acid. Braided MEGASORB™ sutures are coated with polycaprolactone and calcium stearate.
MITSUTM is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made of glycolide and L-lactide. MITSUTM sutures are coated with a mixture containing equal parts of copolymer of glycolide and lactide and calcium stearate.
MITSU FST™ is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made from glycolide and L-lactide. MITSU FST™ sutures are coated with a mixture containing equal parts of copolymer of glycolide and calcium stearate. The rapid loss of strength is achieved by using polymer material with lower molecular weight than that of regular MITSUTM suture.
FILAXYN™ is a sterile synthetic absorbable monofilament suture composed of Poly (p-dioxanone).
FILAPRON™ is a sterile synthetic absorbable monofilament suture is composed of poly(glycolide-co-caprolactone).
All sutures are available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes.
This document is a 510(k) premarket notification for several types of absorbable surgical sutures (MEGASORB, MITSU, MITSU FST, FILAXYN, FILAPRON). It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving novel effectiveness through a new clinical effectiveness study.
Therefore, the typical acceptance criteria and study design for new AI/Medical Device effectiveness, as requested in your prompt (which often includes human reader studies, ground truth establishment by experts, and analysis of effect sizes), are not applicable to this type of regulatory submission.
Instead, the "acceptance criteria" here refer to meeting the performance specifications of the predicate devices and relevant USP standards, and the "study" is a series of laboratory and biocompatibility tests designed to show that the new devices perform equivalently to the predicates.
Here's a breakdown based on the provided document, addressing the closest analogues to your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" but refers to compliance with USP (United States Pharmacopeia) standards and equivalence to predicate devices. The "reported device performance" is implicitly that the devices met these standards and demonstrated substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Physical Properties | Conformance to USP for Diameter | Met USP requirements (implied by "evaluated for... requirements") |
| Conformance to USP for Tensile Strength | Met USP requirements (implied) | |
| Conformance to USP for Needle Attachment | Met USP requirements (implied) | |
| Equivalent Resorption Profile to Predicate | Equivalent to predicate (implied) | |
| Conformance to Suture Length requirements | Met requirements (implied) | |
| Biocompatibility Studies | Non-toxic, non-irritating, non-sensitizing, non-pyrogenic, non-mutagenic, no adverse systemic effects (as per ISO 10993 concepts) | Devices demonstrated biocompatibility, non-pyrogenic properties (implied by listing studies and conclusion of safety) |
| Material/Design Equivalence | Same materials of construction, design, and intended use as predicate devices | Confirmed ("composed of the same materials... and has the same design, as do the predicate.") |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual performance test (e.g., number of sutures tested for tensile strength, number of animals for biocompatibility). It generally states that the "Surgical Suture was subjected to the performance testing as per USP requirements." USP standards often outline minimum sample sizes for specific tests.
- Data Provenance: The tests were conducted by the submitter, Meril Endo Surgery Private Limited, based in India. The studies are prospective in the sense that they were conducted specifically to demonstrate the performance of these new devices for the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: This type of submission (510(k) for surgical sutures) does not involve medical image interpretation or clinical diagnostic tasks that require experts to establish "ground truth" in the way an AI diagnostic device would. Performance is measured against physical and biological standards, not against expert medical consensus on a particular condition.
4. Adjudication Method for Test Set
- Not Applicable: There is no "adjudication method" in the sense of resolving conflicting interpretations by multiple human readers. Lab tests follow standardized protocols. Biocompatibility studies involve expert animal pathologists and toxicologists interpreting results, but this is standard scientific interpretation rather than "adjudication" of a ground truth label in an AI context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: No MRMC study was done. This device is a surgical suture, not a diagnostic imaging device or an AI-assisted tool meant to improve human reader performance.
6. Standalone Performance Study (Algorithm Only)
- Not Applicable: This is not an algorithm or AI device. Its performance is measured directly through physical and biological testing.
7. Type of Ground Truth Used
- For physical properties (diameter, tensile strength, needle attachment, suture length): The "ground truth" is established by objective measurements against predefined scientific standards (USP specifications).
- For resorption profile: The "ground truth" or reference is the resorption profile of the legally marketed predicate device.
- For biocompatibility: The "ground truth" is established by standardized laboratory tests and expert interpretation of biological responses, adhering to recognized toxicology and biocompatibility guidelines (e.g., ISO 10993 series, though not explicitly cited in the summary, is standard practice). There isn't a single "ground truth" label; rather, it's a demonstration that the device's biological interactions fall within acceptable safety limits.
8. Sample Size for Training Set
- Not Applicable: There is no "training set" as this is not a machine learning or AI device.
9. How Ground Truth for Training Set was Established
- Not Applicable: As above, no training set or its associated ground truth.
In summary: The K172659 submission demonstrates substantial equivalence for absorbable surgical sutures by showing that these new devices meet established performance standards (primarily USP) and exhibit similar material compositions, designs, and intended uses to existing predicate devices. The evaluation focuses on laboratory testing and biocompatibility assessments rather than clinical performance studies that would involve human readers or AI algorithms.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.