(65 days)
The Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable are intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fracture fixation when used with bone plates and screws and for the stabilization of bone graft material.
The Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable described in this submission are modifications of the existing cable and beaded cable. The difference between the new stainless steel devices and the existing cables cleared in submissions K844068 and K961569 is the material (22-13-5 ESR vs. 316L) and the manner in which the cable is manufactured (Homogeneous strands vs. Non-Homogeneous). There are no other differences in the design, manufacturing method, or principles of operation between the two types of cables.
The provided document is a 510(k) premarket notification for a medical device (Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested in your bullet points regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's why and what information is available:
- No Acceptance Criteria or Device Performance Table: The 510(k) pathway for medical devices does not typically involve defining and meeting specific quantitative performance acceptance criteria in the same way a drug trial or a novel high-risk device study would. Instead, substantial equivalence is established by comparing the new device's technological characteristics, intended use, and materials to a predicate device already on the market.
- No "Study" as you've defined it: There isn't a clinical performance study described in the document to "prove the device meets the acceptance criteria." The submission is a regulatory filing demonstrating equivalence.
- No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, or Standalone Performance: These details are relevant to clinical performance studies, which are not detailed in this 510(k) summary.
- No Ground Truth for Training Set: The concept of a "training set" and "ground truth" (as used in machine learning or diagnostic imaging) is not applicable here. This device is a surgical cable, not an AI/ML-driven diagnostic tool.
Information that is available from the document:
- Device Name: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable
- Intended Use / Indications for Use: For spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Also for supplementary fracture fixation with bone plates and screws and stabilization of bone graft material.
- Material Difference from Predicate: The new device uses 22-13-5 ESR stainless steel and homogeneous strands, compared to the predicate's 316L and non-homogeneous strands.
- No Other Differences: "There are no other differences in the design, manufacturing method, or principles of operation between the two types of cables."
- Predicate Devices: Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926); Dall-Miles Homogeneous Cable, Vitallium® (K945294); Dall-Miles Suture/Beaded Cable (K953818); and Dall-Miles Stainless Steel Beaded Cable, 316L (K961569).
- Date of Summary: May 9, 1997
- FDA Clearance Date: July 16, 1997
- Regulatory Class: Class II
- Product Code: JDQ
In summary, for this type of medical device clearance (510(k) for a surgical implant), the regulatory pathway focuses on demonstrating substantial equivalence to existing devices rather than a detailed performance study with specific acceptance criteria as you've outlined.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.