(215 days)
The ENDO Absorbable Interference Screw is indicated for use in graft fixation in the repaid and reconstruction of the cruciate ligaments of the know, during open and arthroscoppic surgery.
The ENDO Surgical Concepts, Inc. Absorbable Interference Screws have technological characteristics that are the same as absorbable bone and interference screws currently in interstate commerce that have been registered with the Food and Drug Administration under a 510(k). The subject screws are made of absorbable polymers such as polylactic acid, polyglycolic acid, or other, or copolymers. The competitive screws are comparable in the range of sizes, screw pitch, and hex sizes. The interference screws are also comparable in terms of clinical function to metallic interference screws and ligament buttons that have been registered under a 510(k) and used for fixation of grafts, as described in the attached articles.
Here's a breakdown of the acceptance criteria and study information for the ENDO Absorbable Interference Screws, based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices and established clinical efficacy of the surgical procedure and similar devices. The core "acceptance criterion" is the demonstration that the ENDO Absorbable Interference Screws are safe and effective and function comparably to existing devices used for graft fixation in cruciate ligament repair.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Document) | Reported ENDO Absorbable Interference Screw Performance |
|---|---|
| Safety and Effectiveness for Intended Use: Bone to bone fixation, fixation of bone patella bone and semitendonosus or tendon grafts in the repair of cruciate ligaments during open or arthroscopic surgery. | Claimed Safe and Effective: "ENDO Surgical Concepts believes that the Absorbable Interference Screw System is safe and effective." |
| Technological Characteristics Equivalence: Comparable to absorbable bone and interference screws currently in interstate commerce (polylactic acid, polyglycolic acid, or other copolymers; comparable in range of sizes, screw pitch, hex sizes). | Claimed Equivalent: "The ENDO Surgical Concepts, Inc. Absorbable Interference Screws have technological characteristics that are the same as absorbable bone and interference screws currently in interstate commerce..." |
| Clinical Function Equivalence: Comparable to metallic interference screws and ligament buttons in clinical function. | Claimed Equivalent: "...interference screws are also comparable in terms of clinical function to metallic interference screws and ligament buttons." Specific studies cited show high percentages of good/excellent results for the surgical procedure using interference screws, and comparable clinical results between interference screws and ligament buttons. |
| Initial Pullout Strength: Comparable to metallic screws and well above forces expected in the immediate postoperative period. | Claimed Comparable: "In vitro testing has documented the initial pullout force for polylactic acid absorbable interference screw to be comparable to metallic screws with the force being well above the force expected to be applied to the construct in the immedicate postoperative period." |
| Minimization of known problems (e.g., graft advancement, screw damage to suture, tendon laceration): Designed to address "pitfalls" identified in literature. | Addressed in Design: Tapered tip, cannulated design with guide wire, radiused thread tips, associated cannula to protect sutures/tendons during insertion. |
| Minimization of known device malfunctions (e.g., screwdriver breakage, screw cracking): Designed to reduce issues seen in MDR reports for predicate devices. | Addressed in Design: Uses a stronger 3.5mm hex drive (vs. 2.5mm), one-piece driver shaft (no welds), designed with wall thickness and drive system to minimize cracking in the drive region. |
Study Information
The document relies primarily on a literature review and comparison to predicate devices, rather than a single, controlled clinical trial specifically for the ENDO Absorbable Interference Screws.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the context of a dedicated "test set" for the ENDO device in a standalone study. The document refers to data from numerous previous studies, reviews, and clinical experiences.
- Data Provenance: The data referenced is from published orthopedic literature and the "reputation, clinical use, and clinical results" of the surgical procedure over "more than ten years of experience." Specific articles mentioned include authors like Lambert (1983), Kurosaka (1987), Fulkerson, Lemos, Matthews, Hulstyn, Cassin, Hecker, Shelbourne, O'Brien (1991), and Buss (1993). These likely represent data from various countries and institutions as is typical for broad orthopedic literature. The studies are predominantly retrospective analyses of surgical outcomes or in vitro mechanical testing.
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)
- Number of Experts: Not explicitly stated as a defined group for a specific "test set." The "ground truth" is established through the consensus and findings of the broader orthopedic community, as reflected in decades of published research, clinical practice, and orthopedic meetings.
- Qualifications of Experts: The experts are the authors and researchers in the orthopedic literature cited, presumably orthopedic surgeons, biomechanical engineers, and other medical professionals specializing in cruciate ligament repair and sports medicine. Their specific years of experience are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There was no single "test set" requiring adjudication by a panel for this submission. The "adjudication" is essentially the peer review process of clinical research and the general acceptance within the orthopedic field.
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
- MRMC Comparative Effectiveness Study: No, this is not an AI-based device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted. This document describes a medical device (surgical screw) for mechanical fixation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm. Its performance relies on its inherent mechanical properties and its interaction with the human body and surgical technique.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth is primarily established through:
- Clinical Outcomes Data: High percentages of "good and excellent results" reported in orthopedic literature for the surgical procedure using interference screws.
- Expert Consensus: The long history of favorable results and the designation of the procedure as the "Gold Standard" in the orthopedic community.
- Pathology/Biomechanical Principles: In vitro mechanical testing demonstrating fixation strengths.
- Comparative Clinical Studies: Papers directly comparing interference screws with other fixation methods (e.g., ligament buttons) and showing comparable results (e.g., 93 out of 100 points on the HSS rating scale).
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no "training set" in the context of an algorithm or AI. The design of the ENDO Absorbable Interference Screws was informed by a broad review of existing knowledge, clinical experience, and identified issues (MDR reports, literature on pitfalls), which could be considered analogous to "training data" for a product development process, but not in statistical machine learning terms.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: As above, not a formal "training set." The information that guided the design of the ENDO screw came from:
- Literature reviews identifying "pitfalls in the use of interference screws" (e.g., Matthews' article).
- MDR reports detailing device malfunctions (e.g., screwdriver breakage, screw cracking) for predicate devices.
- Knowledge of biomechanical principles in surgical fixation.
- Existing established successful designs and techniques in the field.
The "ground truth" for design improvements was the identification of specific problems with previous devices or techniques that the ENDO screw aimed to mitigate.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.