(166 days)
The Axya Suture Welding System is indicated for use in securing sutures in soft tissues and for securing ligatures of tubular structures wherever conventional sutures or surgical staples are appropriate. The System may be used in arthroscopic, laparoscopic and open surgical procedures.
The Suture Welding System described in this Notice is a fully disposable singlepatient-use hand-piece with an internal (battery) power supply/controller. This device is designed for use in securing a specific suture (Axya Medical Tufflex™ Polyester suture) with a weld rather than with a traditional knot. This reduces the bulk of the suture fastening point and eliminates the possibility of knot slippage. The single-patient-use device eliminates the need for repair and maintenance of suture welding devices with reusable power supply/control units.
The provided text describes the Axya™ Suture Welding System and Kit, a device designed to secure sutures with a weld rather than a traditional knot. The submission aims to establish substantial equivalence to predicate devices.
Here's an analysis of the provided text in the context of the requested information, while noting that some information is not explicitly present in the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalence to predicate devices and established standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suture Holding Strength (Efficacy): Equivalent to conventional knotting techniques and above USP requirements for suture material. | "Data were presented which demonstrate that sutures placed by means of the suture welding process exhibit 'knot strength' characteristics above the USP requirements for the USP suture material tested. These tests confirm that sutures placed with the suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques." |
| "Sutures welded in a fluid environment meet USP knot strength requirements." | |
| Safety (Biocompatibility): No unusual adverse histopathologic change compared to traditional methods. | "In this animal model there was no unusual adverse histopathologic change seen at the suture implant sites where the suture was welded. The investigators concluded that there was no significant difference in safety of efficacy between the traditional method of suture placement and the technique which replaces manual knot-tying with suture welding." |
| Protection from Thermal Injury: Device design protects tissues. | "The design of the device protects tissues from potential thermal injury." |
| No New Chemical Entities: Welding process introduces no new chemical entities. | "No 'flux' or 'welding rod' is employed and no new chemical entities are introduced or produced in the welding process." |
| Sterility: Components are sterile. Validate processes. | "The single-patient-use components of the System and Kit are provided sterile. The sterility processes, the manufacturing process, and the packaging process are validated by the manufacturer." |
Study Details:
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Sample size used for the test set and the data provenance:
- In vitro studies: The specific sample size for the in vitro studies (e.g., number of welds tested for knot strength) is not provided.
- In vivo studies: The specific number of animals (New Zealand rabbits) used for the in vivo testing is not provided, though it mentions "bowel tissue of the New Zealand rabbit."
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be conducted by or for Axya Medical, Inc.
- Retrospective or Prospective: Both in vitro and in vivo studies described appear to be prospective in nature, designed specifically to test the device's performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document mentions "investigators" for the animal study ("The investigators concluded that there was no significant difference..."). However, the number and specific qualifications of these experts are not provided. For in vitro studies, it's implied that standard laboratory practices and personnel were involved in performing tests against USP requirements.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any formal adjudication method like 2+1 or 3+1 for establishing ground truth from multiple experts. The conclusion from the animal study appears to be a consensus of the "investigators."
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance in interpretation. The comparison is between a device-secured suture and a manually-knotted suture in terms of physical performance and biological response.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the device is a physical surgical tool and not an algorithm. Performance is assessed directly through physical and biological testing of the device's output (welded sutures).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- In vitro: Ground truth for suture strength was established by USP (United States Pharmacopeia) requirements for suture materials.
- In vivo: Ground truth for safety/efficacy in the animal model was established through histopathologic evaluation (pathology) for adverse changes and likely observed functionality/healing, with conclusions drawn by "investigators."
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The sample size for the training set:
- This concept is not applicable to this type of medical device. The Axya Suture Welding System is a mechanical/thermal device, not an AI-based system that requires a "training set."
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How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above (not an AI 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.