(314 days)
The Surgical Dynamics™ Meniscal Staple** is indicated for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.
The Surgical Dynamics™ Meniscal Staple** consists of a resorbable braid connecting the two resorbable legs of the staple. The staple is used in the approximation of soft tissue, specifically the meniscus. The device is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acids which are then metabolized by the body.
The submitted text doesn't provide detailed acceptance criteria or a specific study that unequivocally "proves" the device meets them in the format requested. Instead, it describes a 510(k) submission for a medical device (Surgical Dynamics™ Meniscal Staple) and the FDA's decision regarding its substantial equivalence to a predicate device.
The essential information provided is that "In vitro and in vivo performance testing demonstrated Surgical Dynamics™ Meniscal Staple is suitable for use in the approximation of meniscal tissue." However, the specifics of this testing, including detailed acceptance criteria, methodology, sample sizes, ground truth establishment, or expert involvement, are NOT included in the provided text.
Therefore, many of the requested fields cannot be directly populated from the given input. I will fill in what can be inferred or directly stated from the text and note when information is missing.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided 510(k) summary for the Surgical Dynamics™ Meniscal Staple indicates that "In vitro and in vivo performance testing demonstrated [the device] is suitable for use in the approximation of meniscal tissue." However, the document does not explicitly detail the acceptance criteria used for this testing or provide the full study report. The FDA's 510(k) clearance is based on a determination of substantial equivalence to a predicate device (PDS II Suture. Ethicon, Inc.), rather than a direct demonstration of meeting a specific performance standard outlined in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/Abstract) | Reported Device Performance |
|---|---|
| Mechanical Integrity/Strength: | Demonstrated suitability for approximation of meniscal tissue. |
| Biocompatibility: | All component materials are biosafet and in accordance with ISO Standard #10993-1. |
| Resorbability/Degradation Profile: | Degradation and resorption in vivo by hydrolysis into lactic and glycolic acids, then metabolized. |
| Tissue Approximation Effectiveness: | Demonstrated suitability for use in the approximation of meniscal tissue. |
| Safety (In vivo): | Implied as suitable for use, supported by biocompatibility. |
Note: The specific quantitative or qualitative acceptance criteria (e.g., "tensile strength greater than X N", "degradation complete within Y months") are not provided in the document. The reported performance is a general statement of "suitability."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are labeled "In vitro and in vivo performance testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable (no MRMC study mentioned, and this is not an AI-assisted device).
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Was a standalone study done? No, this is a physical medical device (meniscal staple), not an algorithm or AI. Performance testing would have been conducted on the device itself.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For "in vivo" testing, ground truth would typically refer to direct observation of tissue repair, histological analysis, or clinical outcomes. For "in vitro" testing, it would involve objective measurements (e.g., mechanical testing, degradation rate measurements).
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable (no training set).
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.