(119 days)
The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control.
The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.
The Capio™ SLIM Suture Capturing Device is urogynecologic mesh instrumentation used with urogynecologic surgical mesh. The subject device is also intended for use in general suturing applications during surgery to assist in placement of suture material in tissues, and assist in insertion or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair.
The Capio™ SLIM Suture Capturing Device is a sterile, single use device and is designed to be used by the physician to facilitate the placement of sutures in difficult to access locations during open surgical procedures. The Capio™ SLIM device is also designed to throw, catch and retrieve sutures in one step. The device consists of a one-handactivated plunger at the proximal end, a tubular shaft and a curved needle driver at the distal end. Depressing the plunger actuates the carrier and drives the suture/dart through the tissue. The needle is automatically caught by the device's needle catch mechanism for easy suture tying, or the device may be re-loaded for additional suture throws.
This document is a 510(k) summary for a medical device (Capio™ SLIM Suture Capturing Device) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study that proves the device meets specific acceptance criteria in the way a clinical or performance study of an AI/imaging device would.
Based on the provided text, here is an analysis regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria":
This document does NOT describe the acceptance criteria or a study proving device performance in the context of an AI/imaging diagnostic device.
Instead, it describes the non-clinical performance tests conducted to demonstrate that the device meets applicable design and performance requirements and supports substantial equivalence to a predicate device. The "acceptance criteria" in this context refer to the successful completion and passing of these engineering and safety tests.
Here's how to interpret the request with the provided information:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical performance tests. For each test, the "reported device performance" is implicitly that the device passed or met the requirements, thus demonstrating sufficient performance for its intended use and compliance with special controls. Specific numerical criteria or results are not provided for each test in this summary.
| Acceptance Criteria (Test) | Reported Device Performance (Implied) |
|---|---|
| Sterilization Validation | Validated |
| Package integrity testing (real-time aging): | Passed (Dye Penetration, Seal Strength, Visual Inspection) |
| Dye Penetration | Passed |
| Seal Strength | Passed |
| Visual Inspection | Passed |
| Dimensional Test | Met specifications |
| Functional Test | Met specifications |
| Compression Test | Met specifications |
| Tip Tensile Test | Met specifications |
| Side Load Deflection | Met specifications |
| Top Load Deflection | Met specifications |
| Needle Retention Test | Met specifications |
| Catch Pull Test | Met specifications |
| Actuation Test | Met specifications |
| Distribution Challenge of Packaging | Passed |
| Biocompatibility: | Biocompatible (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity) |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation or Intracutaneous Reactivity | Non-irritating |
| Acute systemic toxicity | Non-toxic |
| Material-Mediated Pyrogenicity | Non-pyrogenic |
| Shelf-life Testing | Supports a three-year shelf life |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests described are primarily engineering, mechanical, and biological tests on device prototypes or manufactured units, not on a "test set" of patient data.
3. 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)
This information is not applicable and therefore not provided. The ground truth for these non-clinical tests is based on established engineering standards, material science, and biological testing protocols, not expert medical opinion on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or uncertain diagnoses, which is not the case for these non-clinical device tests.
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
There was no MRMC comparative effectiveness study done. This device is a physical surgical instrument, not an AI or imaging device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There was no standalone (algorithm only) performance study done. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained previously, for the non-clinical tests, the "ground truth" is based on:
- Engineering standards and specifications: For dimensional, functional, compression, tensile, deflection, needle retention, catch pull, and actuation tests.
- Established protocols for sterilization and packaging integrity: For sterilization validation, package integrity, and distribution challenge tests.
- Standardized biocompatibility test methods: For cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
- Industry standards for accelerated and real-time aging: For shelf-life testing.
8. The sample size for the training set
This is not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/machine learning device.
In summary, the provided document describes the engineering, mechanical, sterility, packaging, and biocompatibility performance data for a physical surgical device, demonstrating that it meets design requirements and supports substantial equivalence. It does not contain information typically associated with clinical studies or AI device performance evaluation.
§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
(a)
Identification. Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).(b)
Classification. Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible;
(2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed;
(3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life;
(4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh design that may be used with the device;
(ii) Detailed summary of the clinical evaluations pertinent to use of the device;
(iii) Expiration date; and
(iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.