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The ODi Compression Hip Screw System will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, some high subtrochanteric fractures and intracapsular fractures, provided that weight bearing is not allowed until the fracture shows evidence of union. The device is intended to stabilize fragments of the fracture until bony union can occur.

The Orthopedic Designs, Inc. Compression Hip Screw System is a cannulated lag and compression screw system to be used with a side plate for fracture fixation and stabilization of the proximal femur until bony union can occur. The system includes a lag screw that may be utilized alone with a side plate, or for compression of a fracture, may be used with a compression screw. Each system shall consist of the same material when used and shall not be mixed. Titanium Alloy and Stainless Steel within the same use. The distal end of the lag screws are keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the lag screw within the head of the femur. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the lag screw. A compression screw locking mechanism called a jam screw is also available, providing a safe mechanism to lock the compression screw in place. The jam screw will prevent a common natural migration of the compression screw from the lag attachment. The side plates, lag screws, compression screws, cortical bones screws and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution. A range of system component sizes and lengths will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.

The provided K971993 510(k) Premarket Notification for the ODi Compression Hip Screw System is a regulatory submission for medical device clearance, not a clinical study report. As such, it does not contain the detailed information requested about acceptance criteria, device performance, test set characteristics, expert qualifications, adjudication methods, or training set details that would typically be found in a detailed study report.

The document primarily focuses on establishing substantial equivalence to predicate devices. Here's what can be extracted and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

• Indications for use
• Device design
• Materials
• Method of manufacture
• Method of sterilization | The ODi Compression Hip Screw System is described as "similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution."

Specifically, the document states: "Orthopedic Designs, Inc. believes the ODi Compression Hip Screw System is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization." |
| Material Standards:

• Chemical and mechanical requirements for titanium alloy 6AL-4V ELI
• Chemical and mechanical requirements for 316-L stainless steel | Meets ASTM F136-92 for titanium alloy 6AL-4V ELI.
  Meets ASTM F138-92 for 316-L stainless steel. |
  | No FDA Performance Standards:
• No specific FDA performance standards for fixation bone screws. | No FDA performance standards were applicable to this device at the time of submission. |

Missing Information:

• Specific numerical performance metrics (e.g., fracture stability strength, fatigue life numbers, screw pull-out force) that might be expected from a detailed engineering or biomechanical study are not reported or referenced in this summary. The assessment of "equivalence" is qualitative based on design, materials, and intended use as compared to predicate devices.

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

Information Not Provided: The 510(k) summary does not describe a clinical "test set" in the context of an AI/algorithm evaluation. The comparison appears to be based on design specifications, material properties, and intended use against existing predicate devices, rather than a prospective or retrospective study with a specific patient dataset.

• Sample Size (Test Set): Not applicable in this document.
• Data Provenance (Country, Retrospective/Prospective): Not applicable; no patient data described.

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

Information Not Provided: This document does not describe the use of experts to establish ground truth for a test set. This type of information is pertinent to an AI or diagnostic device study, which this is not.

4. Adjudication Method (E.g. 2+1, 3+1, None) for the Test Set

Information Not Provided: Not applicable; no test set or adjudication process described.

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

Information Not Provided: Not applicable. This device is a mechanical orthopedic implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

Information Not Provided: Not applicable, as this is not an algorithm-based device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

Information Not Provided: For this mechanical device, "ground truth" would typically relate to engineering specifications (e.g., material strength, dimensional accuracy, fatigue performance) or successful long-term clinical outcomes from predicate devices. However, this level of detail is not provided in the summary. The "ground truth" for the substantial equivalence claim relies on documented characteristics and performance of the predicate devices.

8. The Sample Size for the Training Set

Information Not Provided: Not applicable. This document pertains to regulatory clearance for a mechanical medical device, not an AI or algorithm-based device that would require a training set.

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

Information Not Provided: Not applicable. No training set is involved.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" presented in this 510(k) Premarket Notification is a substantial equivalence comparison to legally marketed predicate devices, rather than a de novo clinical trial or performance study generating new data for this specific device.

The premise for regulatory clearance (as detailed in the 510(k) process) is that the device is as safe and effective as a predicate device already on the market. The evidence used to support this typically includes:

• Comparison of Design and Materials: The ODi Compression Hip Screw System utilizes materials (Titanium Alloy 6AL-4V ELI or 316-L Stainless Steel) that meet established ASTM standards (F136-92 and F138-92), which are widely accepted for orthopedic implants. The design is explicitly stated as "similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution."
• Comparison of Intended Use and Indications: The indications for use of the ODi system are "common with presently marketed compression hip screw systems" and align with those of the listed predicate devices (fixation/stabilization of intertrochanteric, high subtrochanteric, and intracapsular fractures).
• Reference to Predicate Devices: A comprehensive list of approximately 20 predicate devices from companies like Howmedica, Synthes, Ace, Richards, Zimmer, OFCO, Wright, and Depuy is provided (e.g., Howmedica Compression Hip Screw System K781762, Synthes DHS Hip Screw K791619). The existence and successful use of these devices form the basis of the claim of substantial equivalence.

In essence, the "study" proving the device meets acceptance criteria is the demonstration to the FDA that the ODi Compression Hip Screw System is fundamentally similar to devices already recognized as safe and effective, and that its materials meet recognized industry standards. No new performance data from a clinical trial or a specific algorithmic validation study is detailed in this summary.

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The Vigor Compression Hip Screw is indicated as a means of rigid internal fixation of stable and unstable fractures of the proximal femur in which a stable medial buttress can be reconstructed and is intended for the management of intertrochanteric, subtrochanteric and basilar neck fractures and selected trochanteric non-unions.

The Vigor Compression Hip Screw System is intended as a means of rigid internal fixation for fractures of the proximal femur. The Vigor System implants consist of Bone Screws; Compression Screws, Lag Screws and Side Plates, and are offered in a wide, incremental range of sizes to ensure optimum selection for a proper fixation. The Vigor full-length threaded Bone Screws and Compression Bone Screws are available in a range of sizes from 22.0 mm to 60.0 mm in length. Vigor Lag Screws and Super Lag Screws feature a flattened, square base that engages the inner surface of the implant barrel for increased rotational stability. These Lag Screws are available in a range of sizes from 50.0 mm to 150.0 mm in length, in 5.0 mm increments. And, finally, a trio of low-profile Side Plates are included in the system. Vigor offers the standard 4-hole, 5-hole and 6hole plates, each available in a 135°, 140° or 145° configuration.

The Vigor System instrumentation set consists of the standard instrumentation required for each indicated procedure.

This document describes a medical device submission (510(k)) for the Vigor Compression Hip Screw System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical study to prove novel efficacy or meet specific acceptance criteria with defined performance metrics. Therefore, many of the requested categories related to clinical study design, acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not applicable.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device. The device "performs as well as" the predicate if it matches the predicate's material, design, function, and intended use. The table above highlights how the Vigor system directly matches the predicate in these key aspects.

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

• Not Applicable. This submission is a 510(k) demonstrating substantial equivalence. It does not involve a clinical "test set" in the context of an efficacy or performance study with human subjects or a large dataset for AI evaluation. The "data" provided is a comparison of product specifications and functions against a predicate device.

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

• Not Applicable. See point 2. There is no specific "ground truth" to be established by experts for a test set in this type of submission. The ground truth for the predicate device's safety and effectiveness was established when it was initially cleared by the FDA.

4. Adjudication method for the test set:

• Not Applicable. See point 2. No test set requiring adjudication was used.

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 is a physical medical device (hip screw), not an AI/software device. Therefore, MRMC studies and AI-assisted reading improvements are irrelevant to this submission.

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:

• Substantial Equivalence to a Predicate Device. The "ground truth" for this 510(k) submission is the prior FDA clearance of the Synthes Dynamic Hip Screw (K791619), which serves as the established safe and effective benchmark. The Vigor Compression Hip Screw System's "performance" is considered sufficient if it is substantially equivalent to this predicate.

8. The sample size for the training set:

• Not Applicable. This device submission does not involve a "training set" for an algorithm or a clinical trial in the traditional sense of a de novo device.

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

• Not Applicable. See point 8.

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