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The MOSS Miami Spinal System is intended for non-cervical use in the spine.

When used with anterior screw fixation or posterior hook, non-pedicle screw fixation 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 back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 attachment are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

This product is an addition to the existing MOSS Miami Spinal System and consists of: a sacral extender available in multiple lengths from 2cm to 20cm manufactured from Ti-6Al-4V alloy. This product uses the same inner screw and outer locking nut as the hooks and screws previously cleared in K955348 for use with the Titanium MOSS Miami Spinal System.

The sacral extender consists of a body and a longitudinal extension "arm". The body is intended to be attached to a 5.5mm MOSS Miami Titanium rod placed transversely through the iliac wings and fixed with sacral screws. The extension arm extends longitudinally and allows attachment of MOSS Miami Tranium screws or hooks. The attachment mechanism between the sacral extender body and the longitudinal rod is the same mechanism as is used for the screws and hooks in the MOSS Miami Spinal System cleared for use in K955348.

The provided text K974573 is a 510(k) summary for a medical device (DePuy Motech MOSS Miami Spinal System - Titanium Sacral Extender). This document focuses on demonstrating substantial equivalence to a predicate device and DOES NOT contain information about acceptance criteria or a study proving the device meets said criteria in the way a clinical performance study would.

Here's an analysis based on the information provided, highlighting why many aspects of your request cannot be fulfilled from this document alone:

This document is a marketing clearance application (510(k)), not a clinical study report. Its primary goal is to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving a specific performance metric against pre-defined acceptance criteria through a clinical trial.

1. A table of acceptance criteria and the reported device performance

• Not applicable in this document. The 510(k) process for a device like this does not typically involve setting numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and then reporting device performance against those in the same way a diagnostic AI device would.
• Instead, the "performance" demonstrated here is the device's substantial equivalence to an existing device, primarily based on material, design, and intended use similarities, often supported by non-clinical (e.g., mechanical or biocompatibility) testing, which is not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable in this document. There is no "test set" in the context of a clinical performance study described here. The evaluation is based on a comparison to a predicate device, not on analyzing patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable in this document. No ground truth for a test set is established or discussed, as this is not a diagnostic device undergoing such a validation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable in this document. No adjudication method is described as there is no clinical test set being evaluated for diagnostic or predictive performance.

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 in this document. This device is a surgical implant (spinal system), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable in this document. This is a physical medical device, not an algorithm, so "standalone performance" in this context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in this document. No ground truth in the sense of clinical diagnostic validation is used. The "ground truth" for this 510(k) is the existing, legally marketed predicate device (MOSS Miami Sacral Extender - K972568) to which the new device is compared. Its "truth" is its established safety and effectiveness.

8. The sample size for the training set

• Not applicable in this document. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable in this document. See point 8.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The document describes the Basis of Substantial Equivalence, which acts as the "study" or justification for clearance in a 510(k). The "acceptance criteria" can be inferred as successfully demonstrating that:

1. Similar design: The Titanium Sacral Extender has a similar design to the predicate.
2. Same intended use: The new extender has the same intended use (spinal stabilization).
3. Material Change Analysis: The material change from stainless steel to titanium alloy is addressed (implying material compatibility and performance were considered through other means, though not detailed here).
4. Slight Dimensional Changes: Minor dimensional changes (extender arm diameter, slot width) are assessed for impact on compatibility with the MOSS Miami Titanium system.

The "study" that proves the device meets these (implied) acceptance criteria is the comparison to the predicate device (MOSS Miami Sacral Extender - K972568), arguing that the differences (material change, slight dimensional changes) do not raise new questions of safety or effectiveness. This comparison is the core of a 510(k) submission. Mechanical testing, biocompatibility testing, and perhaps other non-clinical tests would have been performed and submitted to the FDA to support these claims, but the details of those specific tests (e.g., specific acceptance values for fatigue or pull-out strength) are not included in this high-level summary.

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The MOSS Miami Spinal System is intended for non-cervical use in the spine.

When used with anterior screw fixation or posterior hook, non-pedicle screw fixation 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 back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 attachment are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS Miami Spinal System is available in either Stainless Steel or Titanium. The following components are currently available in Stainless Steel: 5mm diameter longitudinal rods, 5-7mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5mm diameter longitudinal rods, 5-8mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers.

This product is an addition to the existing MOSS Miami Spinal System and consists of: a sacral extender available in multiple lengths from 2cm to 20cm. This product uses the same inner screw and outer locking nut as the hooks and screws previously cleared for use with the MOSS Miami Spinal System.

The sacral extender consists of a body and a longitudinal extension "arm". The body is intended to be attached to a 5mm MOSS Miami rod placed transversely through the iliac wings and fixed with sacral screws. The extension arm extends longitudinally and allows attachment of MOSS Miami screws or hooks. The attachment mechanism between the sacral extender body and the longitudinal rod is the same mechanism as is used for the screws and hooks in the MOSS Miami system originally cleared for use in K933881.

The provided document is a 510(k) summary for a medical device (DePuy Motech Stainless Steel MOSS Miami Spinal System, specifically an addition: sacral extender) and a clearance letter from the FDA. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way this request typically implies (e.g., performance metrics for a diagnostic algorithm, clinical trial outcomes for a drug, or specific engineering verification/validation tests with pass/fail criteria for a device).

This document demonstrates substantial equivalence to predicate devices, which is the regulatory pathway for many Class II medical devices in the US. Substantial equivalence is based on similar designs, materials, performance (e.g., fatigue strength), and indications for use, rather than meeting pre-defined performance acceptance criteria from a specific study as would be seen for a novel device or diagnostic.

Therefore, I cannot fulfill the request as phrased. However, I can extract information related to the basis of substantial equivalence, which serves as the "proof" for this type of device submission.

Here's a breakdown of what can be extracted and why other parts of your request cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The regulatory acceptance criterion for a 510(k) is "substantial equivalence" to a legally marketed predicate device.
• Reported Device Performance: Instead of specific performance numbers against criteria, the basis for substantial equivalence is provided.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study that uses a test set of data. It's a regulatory submission demonstrating equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for regulatory clearance is the existing predicate device and its established safety and effectiveness.

8. The sample size for the training set: Not applicable. This is not a machine learning or diagnostic algorithm.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "proof" of device performance/safety:

The "proof" for this device's acceptance (clearance) is articulated as Substantial Equivalence to existing, legally marketed predicate devices. The document explicitly states:

• "The MOSS Miami Sacral Extender is substantially equivalent to the MOSS Miami 5mm longitudinal rod that has been previously cleared for posterior non-pedicle use and limited posterior pedicle fixation. This substantial equivalence is based on similar designs, similar interconnection mechanisms, similar materials, comparable fatigue strength and similar indications for use."
• It also draws comparisons to the "intended technique" for Harrington Rods (pre-amendment devices) and the "L" shaped longitudinal rod/sacral screw construct marketed by Acromed in the ISOLA spinal system for similarity in application.

The FDA's clearance letter confirms this by stating: "we have determined the device system is substantially equivalent... to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act."

In essence, the acceptance criteria for this device were met by demonstrating its fundamental similarity to devices already on the market, implying a similar safety and effectiveness profile without requiring new clinical trials or performance studies against novel endpoints.

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