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The Compression Cerclage Gundolf CCG is suitable for particular forms of osteosynthesis, particularly for cerclage of the greater trochanter and femur associated with revision hip arthroplasties. In contrast to cerclage wires, the CCG compression band allows a functional compression to be achieved. An assumption is made that an indication for implant revision already exists.

• Reattachment of the greater trochanter. .
• Bone support in case of a damaged proximal femur (e.g. by bone cement, . loosered stem, or polyathylene wear particles), with a possible cancellous bone graft in the proximal femur area.
• Cerclage of bone fissures. ll
• Fracture protection during rasping of a new prosthetic canal and prior to . implaritation of a new stem.
• Closing of a cortical fenestration. .
• Fractures in the area of the femoral stem. 이
• 프 To improve bone-cement interface.

In general, CCG and CCG-GF have the same function. In the case of conical shape of the bone, primarily superior to the lesser trochanter, the CCG-GF is indicated rather than theCCG.

The Compression Cerclage Gundolf CCG-GF is manufactured from commercially pure wrought titanium according to ISO 5832-2 and ASTM F-67. It is 270 mm long, 7.7 mm wide and 0.5 mm thick. It has a fastener at the end that allows the band to encircle the bone and attach itself in a belt-like manner. By using a special manual, tightening instrument the band can impart compression to the bone The remaining end of the band is cut off using a wire cutter. It has 2 conical shaped 2.9 mm spikes, which are intended to prevent the cerclage band from slipping and give it more stability during the osteointegration period.

This 510(k) premarket notification (K973098) is for the Compression Cerclage Gundolf CCG-GF. It doesn't contain a detailed study with acceptance criteria and device performance metrics in the way modern AI/software device submissions would.

Instead, this submission is a Substantial Equivalence (SE) determination. This means the device is being compared to a legally marketed predicate device (the CCG Cerclage System, K932024), and the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as the predicate.

Here's a breakdown of why a standard table of acceptance criteria and device performance isn't present, and how to interpret the provided information within the context of a 510(k) submission from 1997:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable in the typical sense for this 510(k) submission. The core "acceptance criteria" for a 510(k) are demonstrating "substantial equivalence" to a predicate device. This is primarily done through a comparison of design, material, strength, indications for use, and contra-indications.
• Implied Performance: The submission states that the CCG-GF and the predicate CCG "have the same function" and are "identical in design, material, strength, indications and contra-indications" with the only difference being the addition of 2 conical spikes. The spikes are intended "to prevent the cerclage band from slipping and give it more stability during the osteointegration period." Therefore, the implied performance criterion is that the CCG-GF performs at least as well as the predicate CCG, with a potential improvement in stability due to the spikes.

2. Sample Size Used for the Test Set and Data Provenance:

• No specific test set or clinical study is described. For 510(k)s, especially for devices like cerclage systems in 1997, clinical studies were often not required if substantial equivalence could be demonstrated through engineering principles, material properties, and comparison to a predicate device with established clinical use.
• Data Provenance: Not applicable, as there's no defined "test set" or clinical data presented for this specific device. The general "provenance" of the predicate device's safety and effectiveness would be its prior market clearance (K932024) and presumably, post-market surveillance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. There is no "test set" and thus no "ground truth" established by experts in the context of a clinical study for this 510(k). The "ground truth" for the predicate device would have been established through its own regulatory clearance and clinical use over time.

4. Adjudication Method for the Test Set:

• Not applicable. No test set described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This is a hardware orthopedic implant, not an imaging or diagnostic AI device. MRMC studies are not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No. This is a hardware orthopedic implant, not an algorithm or AI device.

7. The Type of Ground Truth Used:

• Engineering and Material Comparison, and Predicate Device Performance: The primary "ground truth" used for this 510(k) submission is the established safety and effectiveness of the predicate device (CCG Cerclage System, K932024), coupled with engineering and material specifications of the new device that demonstrate its similarity and non-inferiority. The "ground truth" for the predicate device itself would be based on clinical outcomes, surgeon experience, and long-term use data accumulated since its market entry.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device. There is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

Summary of the 510(k) Approach:

The K973098 submission for the Compression Cerclage Gundolf CCG-GF demonstrates substantial equivalence by:

• Identifying a Predicate Device: The CCG Cerclage System (K932024) sold by Encore Orthopedics, Inc.
• Comparing Design, Material, and Function: The submission explicitly states the new device is "identical in design, material, strength, indications and contra-indications" to the predicate.
• Highlighting Minor Modification: The only difference is the addition of 2 conical spikes, which are explained as an improvement to prevent slipping and improve stability. This modification is presented as enhancing the device's original function without introducing new risks or changing the fundamental mechanism of action.
• Indications for Use: The indications for use are largely identical to the predicate, with a clarification for the CCG-GF in cases of conical bone shapes.

In essence, the "study" proving the device meets "acceptance criteria" is the comparison to the predicate device and the rationale for the minor modification, leveraging the predicate's established history of safety and effectiveness. This is a common pathway for 510(k) clearance, particularly for traditional medical devices with well-understood mechanisms.

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Repair of long bone fractures due to trauma or reconstruction
Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy

The Metagen Activelock™ Cerclage System is used in the management of orthopedic trauma and total joint reconstruction to secure and stabilize segments of bone. The fundamental components of the system are a 4.5 mm wide x 250 mm long metal band, a titanium sleeve which slides onto the band, and a Nitinol clamp which secures the band. There are two metal band designs in the system; a .30 mm thick Ti 6Al-4V band, and a .Smin thick Nitinol band. Both bands in this system are secured with the same Nitinol clamp. The sleeve is a low profile titanium block with slots to accept the band and sharp tines which project into the bony surface. The Nitinol clamp component provides a positive method of securing the band. When viewed from the top the clamp is an open. rectangular block. A side view shows the through slot that accepts and ultimately secures the band. Because of the super-elastic properties of the Niinol material, the clamp component can be physically stretched along its with a cerclage applicator instrument . The cerclage applicator instrument device by design limits the elongation of the slot well within the clamp's elastic range. The clamp is in no danger of undergoing permanent (plastic) deformation.

When the slot is elongated, the band fits easily through the slot. Upon release of the stretching force, the clamp retracts toward its resting position and engages the hand with sufficient force to lock the band securely in place. Mechanical testing of the assembled device comparing the band in both titanium and Nitinol to 18 and 16 gage twisted monofilament wire assemblies shows that the Activelock ™ system exceeds the strength of the twisted wire assemblies.

The provided submission is a 510(k) summary for the Metagen Activelock™ Cerclage System, seeking to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through a dedicated study with specific acceptance criteria that would typically generate the detailed performance data requested. Therefore, many of the requested data points (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, ground truth details, and training set information) are not applicable or provided in this type of submission.

However, based on the "Mechanical Testing" section, we can infer a primary acceptance criterion and its reported performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The text mentions "static tensile tests were performed" comparing the Metagen system (both maximum material condition (MMC) and least material condition (LMC) clamps and bands) against "both 16 gage and 18 gage AISI Type 316L stainless steel cerclage wires." While not a specific number, it indicates a comparative mechanical test rather than a clinical trial with human subjects.
• Data Provenance: The data is generated from in vitro mechanical testing. There's no information on country of origin, and it's by definition a prospective test (not retrospective human data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This was a mechanical engineering test comparing tensile strength of physical devices, not a study requiring expert clinical assessment or ground truth establishment in the traditional sense. The "ground truth" here is the measured tensile strength of the predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This was a mechanical test, not a subjective clinical assessment that would require adjudication.

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:

• Not applicable. This device is a physical cerclage system, not an AI or imaging diagnostic algorithm. There were no human readers or AI in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the comparison was the measured tensile strength of "clinically accepted 16 and 18 gage stainless steel cerclage wire." This is an objective, quantitative measurement from mechanical testing of existing, predicate devices.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI model.

9. How the ground truth for the training set was established:

• Not applicable for the reason above.

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