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LOSPA IS ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indication:

1. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

2. Trauma (including fractures)

3. Tumors

4. Deformities or curvatures (including kyphosis, lordosis or scoliosis)

5. Pseudoarthrosis

6. Failed previous fusion.

LOSPA IS ACP System is composed of a bone plate (a locking mechanism is preassembled to plates) and screws. The design features are common with the design features of the predicate devices. Plates have a Low profile with windows. A locking system between plate and screw which also prevents back out. Plates attach to the anterior cervical spine with a minimum of four screws per plate. The plate ranges in length to accommodate one, two, three, and four level procedures. Available in multitude of similar sizes to suit the individual pathology and anatomic condition of the patient. Screws are available as Self-tapping & Self-drilling types. Fixation can be Fixed, Variable or Hybrid types. Both the plate and screws are made of Titanium alloy as described in ASTM F136, ISO 5832-3. Implant is available as non-sterile & sterile.

LOSPA IS ACP System is available in

• . Width of 18 mm & Thickness of 1.9 and 2.3 mm and Levels 1 to 4 with height ranging from 20 to 110 mm.
• Screw has Core Dia. 2.5 & Outer Dia. 4.0, 4.5 with length ranging from 12 to 18mm.

The provided text is a 510(k) Summary for the LOSPA IS ACP System, a spinal intervertebral body fixation orthosis. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific performance acceptance criteria in the way a clinical trial or a standalone AI algorithm study would.

Therefore, much of the requested information regarding a "study that proves the device meets the acceptance criteria" (specifically for AI or clinical efficacy based on patient outcomes) is not present in this regulatory submission. This document primarily describes mechanical performance testing to show the device is as safe and effective as its predicates.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for each test, nor does it typically report specific performance values for the predicate devices for direct comparison in this summary. Instead, it makes a general statement about the results.

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

• Sample Size: Not explicitly stated for each mechanical test. For medical devices, mechanical testing is performed on a sufficient number of samples (typically n=5 to n=10 per test condition) to demonstrate statistical significance or consistent performance. However, the exact numbers are not in this summary.
• Data Provenance: The mechanical and sterilization testing would have been conducted in a laboratory setting, likely by Corentec Co., Ltd. or a contracted testing facility. This is not patient data; it's device performance data.

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

This question is not applicable in the context of this device and report. This is a spinal implant, and mechanical testing is performed according to recognized engineering standards (ASTM, ISO). There is no "ground truth" derived from expert consensus like in an AI diagnostic study. The "truth" is determined by the physical properties and performance of the device under stress, measured quantitatively.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing involves objective measurements rather than subjective assessments requiring adjudication.

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

No. An MRMC study is typically for evaluating the diagnostic performance of imaging systems or AI algorithms with human readers. This document describes a physical medical implant, not an imaging or diagnostic AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question applies to AI algorithms. The LOSPA IS ACP System is a physical medical device.

7. The Type of Ground Truth Used

• Mechanical Performance: The "ground truth" is established by adherence to recognized international and national standards for spinal implant testing (e.g., ASTM F1717, ASTM F543). The tests define how specific mechanical properties (like strength, fatigue resistance, and screw retention) are measured. The acceptance is based on meeting or exceeding the performance of the predicate devices under these standardized tests.
• Biocompatibility/Sterility: Ground truth is established by recognized standards (e.g., AAMI ST72 for pyrogenicity, ISO standards for sterilization).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

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