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When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 – S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 – S1), and for whom the device system is intended to be removed after solid fusion is attained.

Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.

The provided text describes the Moss Miami Spinal System Pin Nut (K023804), a spinal fixation device. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.

The document is a 510(k) summary and an FDA clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed studies.

Here's a breakdown of what can be extracted and what is missing from the provided text, relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical or qualitative acceptance criteria (e.g., tensile strength, fatigue life, torque strength, biocompatibility standards).
• Detailed performance results against those criteria. The document only states that "Data were submitted to characterize" the device.

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

Missing Information. The document mentions "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" but does not provide details about any specific test sets, their sample sizes, or the provenance of any data (e.g., country of origin, retrospective/prospective). This likely refers to mechanical testing data, which typically is conducted in a lab setting, not on patient data.

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

Missing Information. This type of information (expert review, ground truth establishment) is typically relevant for diagnostic or AI-driven devices. As this is a spinal implant, the "ground truth" would be established through mechanical testing standards, rather than expert review of images or clinical cases.

4. Adjudication Method for the Test Set:

Missing Information. Not applicable for a mechanical implant's performance testing.

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

Missing Information. Not applicable. The device is a spinal implant, not a diagnostic imaging or AI assistance tool that would involve human readers.

6. Standalone Performance Study:

Present (Implied): The statement "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" implies that some form of standalone performance (mechanical testing) was conducted on the device itself.

Missing Information:

• Details of the standalone performance studies (e.g., type of tests, parameters measured, results).
• Any comparison to a "human-in-the-loop" scenario, as the device is an implant.

7. Type of Ground Truth Used:

Implied: The "ground truth" for a device like this would be established by mechanical testing standards (e.g., ASTM or ISO standards for spinal implants) and material specifications (ASTM F-136, ASTM F-138). The device's materials are explicitly stated: "Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel." This indicates that material properties conforming to these standards would be part of the "ground truth."

Missing Information: Specific details of these mechanical tests and their corresponding "ground truth" (e.g., required fatigue cycles, pull-out strength).

8. Sample Size for the Training Set:

Missing Information. Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning or algorithms.

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

Missing Information. Not applicable, as there is no training set.

Summary of what the document does provide:

• Device Name: Moss Miami Spinal System Pin Nut
• Manufacturer: DePuy AcroMed, Inc.
• Date Prepared: August 2, 2002
• Predicate Device: Moss Miami Spinal System Titanium Pin Nut (K010742)
• Intended Use/Indications: Detailed for various spinal conditions, including scoliosis, kyphosis, lordosis, fracture, tumor, spinal stenosis, spondylolisthesis, previously failed fusions, and degenerative disc disease. Specific indications for pedicle screw fixation in skeletally mature patients and severe spondylolisthesis (Grades 3 and 4) at L5-S1.
• Materials: ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.
• FDA Clearance: K023804 granted on January 23, 2003, based on substantial equivalence to predicate devices.

In conclusion, the provided text is an FDA 510(k) summary and clearance letter, designed to demonstrate substantial equivalence for market clearance. It does not contain the detailed studies or acceptance criteria that would typically be found in a detailed device performance report or scientific publication for a new technology, especially not in the context of AI or advanced diagnostic algorithms. The "performance data" mentioned likely refers to mechanical and material data submitted to the FDA but not elaborated upon in this public summary.

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