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When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the Mahe Perfect Spine - Pedicle Screw System is 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. Iumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) tumor, and (6) failed previous fusion (i.e. pseudarthrosis). In addition, when used as a pedicle screw system placed between L3 and S1, the Mahe Perfect Spine - Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft and with removal of the device after solid fusion is established.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Mahe Perfect Spine - Pedicle Screw System is intended for use in skeletally mature patients and pediatric patients for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) tumor resection, and/or (7) unsuccessful previous attempts at spinal fusion (pseudoarthrosis).

When intended for anterolateral fixation of the T6-L5 spine the Mahe Perfect Spine - Pedicle Screw System is indicated for: (1) degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e. fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis}, (6) tumor and (7) failed previous fusion.

The Mahe Perfect Spine - Pedicle Screw System consists of a variety of shapes and sizes of rods, hooks, monoaxial and polyaxial screws, cross connectors, as well as appropriate instrumentation.

The Mahe Perfect Spine - Pedicle Screw System components are fabricated from titanium alloy per ASTM F136.

The system is sold non-sterile, the products have to be sterilized prior to use.

The provided text details a 510(k) submission for the Mahe Perfect Spine - Pedicle Screw System. This is a medical device for spinal fixation, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it relates to AI/ML device performance (e.g., accuracy, sensitivity, specificity, F1-score) is not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data and technological characteristics.

Here's how the information provided relates to the typical framework for medical device clearance in this context:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI/ML device, there are no "acceptance criteria" for metrics like sensitivity or accuracy. The "acceptance criteria" here are implicit in demonstrating substantial equivalence through mechanical testing, material specifications, and intended use.

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

• Test Set: The "test set" in this context refers to the samples of the device components that underwent mechanical testing. The specific number of samples for each test (static compression bending, static torsion, dynamic compression bending, etc.) is not explicitly stated in the provided text.
• Data Provenance: The data comes from non-clinical laboratory testing performed on the device itself ("the worst case construct"). There is no mention of country of origin for the data or whether it's retrospective or prospective, as it's a materials/mechanical engineering study, not a clinical trial.

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

• This question is not applicable to this type of device submission. "Ground truth" in the context of expert consensus is relevant for diagnostic AI/ML devices where experts annotate data for algorithm training and evaluation. For a spinal fixation system, the "ground truth" for its performance is derived from standardized mechanical testing against established engineering benchmarks and comparison to predicate devices, not expert human assessment of images or clinical outcomes in a test set.

4. Adjudication Method:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in establishing ground truth for diagnostic AI/ML systems. This is a mechanical device, not an AI/ML diagnostic.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a surgical implant, not a diagnostic tool that assists human readers.

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

• Not applicable. This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is derived from objective, standardized mechanical testing results (e.g., measurements of bending strength, torsion resistance, fatigue life) compared against established performance characteristics of legally marketed predicate devices and relevant industry standards (ASTM F1717-10, ASTM F2193-02, ASTM F1798).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of a mechanical medical device submission. Training sets are for machine learning algorithms.

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

• Not applicable. As there is no training set, this question is not relevant.

In summary: The provided document is for a traditional medical device (spinal fixation system) seeking 510(k) clearance based on substantial equivalence to predicate devices, primarily supported by non-clinical mechanical performance data and material specifications. The questions concerning AI/ML evaluation metrics, expert consensus, and ground truth establishment for algorithms are outside the scope of this submission.

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The Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.

Mahe Fixation Plate and Screw System consists of various shape and sizes plates featuring compression and locking or non-locking holes, fullthreaded-cortical, short threaded-cancellous, locking or non-locking, cannulated, self-tapping or non-self-tapping screws, compression and dynamic screws, implantable K-wires, pins, washers, and appropriate instrumentation. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The plates and screws are fabricated from stainless steel and titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in following models available: Tubular Plates, Reconstruction Plates, Cloverleaf Plates, Calcaneus Plates, Anatomical Plates, Clavicula Hook Plates, Small Fragment, Locking Plates, and DHSP/DCSP Screw Plates. The thickness of the plates varies from 1.2mm to 10mm; the length varies from 26mm to 317mm; and the number of the holes varies from 2 to 22. The screw implants are in three different diameter sizes (2.7mm, 3.5mm, and 4.0mm) and the K-wire implants are in various lengths (from 70mm to 310mm) and diameter sizes (from 0.8 to 3mm) available. The system is sold non-sterile, the products have to be sterilized prior to use.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance for the non-clinical performance data. It mentions that "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures," suggesting real-world data from Europe, but this is not a formal "test set" in the context of a controlled study.

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

This information is not provided in the document. The data presented is primarily non-clinical "performance data" such as testing against industry standards, biocompatibility, and mechanical properties, rather than data requiring expert-established ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical performance data (e.g., mechanical testing against standards).

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

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data and a comparison of technological characteristics to predicate devices.

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

This is not applicable as the device is a medical implant (plates, screws, and pins), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" is established by:

• Industry Standards: Compliance with established international and national standards (ISO 5838, ASTM F366-04, ASTM F0543-07, ASTM F 382-99).
• Predicate Device Performance: Direct comparison of functional and mechanical properties against legally marketed predicate devices.
• Biocompatibility Testing: Results of established biocompatibility tests.

There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus) in the context of a clinical study for this 510(k) summary.

8. The Sample Size for the Training Set

This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.

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

This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.

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