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The LOSPA IS Spinal Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, the LOSPA IS Spinal Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudarthrosis. or revision of failed fusion attempts.

LOSPA IS Spinal System cleared under K092076 is modified for inclusion of 5.5 diameter rods. The rod link (type -B) & pedicle screws are also modified to include 5.5 diameter rods. The rods are available in straight and pre bent configurations for optimal anatomical adjustment. The rod ends are either flat or bullet nosed. The bullet nose might eases navigation through soft tissue. The subject and predicate devices are similar in design, material, specification and manufacturing and are not altered and remain the same as discussed in K092076. Only the prebent rod is additionally available in CoCrMo alloy. The set screw used in the pedicle screw in is the same as approved in K092076, made up of Ti alloy (ASTM F 136) and can be used with both 5.5 mm and 6.0 mm rod system.

The LOSPA IS spinal system is this submission comprises of the following components,

• A. Pedicle Screws (Monoaxial & Polyaxial), standard and guided types, with screw diameters from 4.0 mm to 8.5 mm and length ranging from 20 mm to 55 mm. made up of Titanium Alloy (ASTM F 136).
• B. Straight Rods of diameter of 5.5 mm (Standard) made up of Titanium Alloy (ASTM F 136).
• C. Prebent Rods of diameter 5.5 mm (Standard & Bullet types) made up of Titanium . Alloy (ASTM F 136) & CoCr (ASTM F 1537)
• D. Rod link 5.5 (Type B) made up of Titanium Alloy (ASTM F 136).

All the components are manufactured from medical grade titanium alloy (ASTM F 136) & CoCrMo alloy (ASTM F 1537).

The provided text describes the Corentec Co., Ltd. LOSPA IS Spinal System (K132644), which is a pedicle screw spinal system.

Here's an analysis based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions that "Corentec's LOSPA IS Spinal System modified components were subjected to a series of testing protocols." However, it does not specify the sample size for these tests (e.g., number of components tested for static or dynamic properties). The tests are described as being conducted on the modified components of the device itself, not on patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable as this is a device performance study, not a clinical study.

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

Not applicable. This is a device performance study involving mechanical testing against international standards, not a study evaluating expert interpretation or diagnosis.

4. Adjudication Method for the Test Set:

Not applicable. The "test set" refers to the device components undergoing mechanical testing, not a set of clinical cases requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document describes mechanical performance testing of the device components, not a clinical study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This device is a spinal implant system, not an algorithm or AI. The study presented is a mechanical performance study.

7. Type of Ground Truth Used:

The ground truth for the device performance was established through international standards (ASTM F1717 & ASTM F1798). The device's performance was measured against the requirements and methodologies outlined in these standards, and its results were compared to predicate devices that also presumably met these standards.

8. Sample Size for the Training Set:

Not applicable. This is a mechanical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for a mechanical device.

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