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PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and TransContinental® M Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, and TransContinental® and TransContinental® M Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. The Constitution® PLIF Spacer is inserted using a posterior approach. The Signature® TLIF Spacer is inserted using a transforaminal approach. The Continental® ALIF Spacer is inserted using an anterior approach. The Transcontinental® and Transcontinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). The Signature® R Spacer also includes an internal titanium alloy or commercially pure titanium (ASTM F67) component, and the TransContinental® M Spacer also includes an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295).

The provided text describes a 510(k) submission for PATRIOT® Spacers, which are intervertebral body fusion devices. The submission aims to gain clearance for additional spacers and sterile lumbar PATRIOT® spacers. The study presented is a confirmatory static compression testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Confirmatory static compression testing was conducted in accordance with ASTM F2077-03 with the subject device meeting all acceptable criteria." This indicates that the acceptance criteria were defined by the ASTM F2077-03 standard, and the device successfully met those criteria.

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

This information is not provided in the document. The text only mentions "confirmatory static compression testing" without specifying the number of samples or whether the data was retrospective or prospective, or its country of origin.

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

This information is not applicable to this type of study. The study involves mechanical testing (static compression testing), not clinical or diagnostic evaluation requiring expert review of medical data. The "ground truth" here is the performance metrics defined by the ASTM standard.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or adjudication involved in static compression testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This study is a mechanical test for substantial equivalence, not a clinical study involving human readers and AI assistance.

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

No, this is not an algorithm-based device. PATRIOT® Spacers are physical medical devices (intervertebral body fusion devices), and the testing described is mechanical performance testing, not software or AI algorithm testing.

7. The Type of Ground Truth Used

The ground truth used for this study is the performance specifications and criteria outlined in the ASTM F2077-03 standard for static compression testing of intervertebral body fusion devices.

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical performance study, not a machine learning study that would have a training set.

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

This information is not applicable as there is no training set for this type of mechanical testing.

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(Constitution™ PLIF. Continental TM ALIF. PATRIOT™ Spacers TransContinental™ LLIF and Signature™ TLIF Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.

The PATRIOT™ Spacers (Constitution™ PLIF, Signature™ TLIF . Continental™ ALIF, and TransContinental™ LLIF Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. Each of the PATRIOT™ Spacers provides a different shape to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal, anterior). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT™ Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

The provided text does not contain information about acceptance criteria or a study proving device performance in the sense of clinical effectiveness or diagnostic accuracy for the PATRIOT™ Spacers.

Instead, 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 previously legally marketed predicate device, rather than proving performance based on specific statistical acceptance criteria from a clinical trial.

Here's a breakdown of what the document does state in relation to your questions, and what it does not provide:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for clinical outcomes or diagnostic accuracy. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence under the "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007.
   • Reported Device Performance: The document states, "PATRIOT™ Spacers have been evaluated in accordance with the 'Class II Special Controls Guidance Document: Intervertebral Fusion Device', June 12, 2007 and have been found to meet the criteria set forth in the guidance document in terms of indications, design, and performance." This broadly indicates compliance with regulatory expectations for safety and effectiveness, but does not provide specific performance data (e.g., fusion rates, complication rates, improvements in patient-reported outcomes) that would be derived from a clinical study with predefined acceptance criteria. This is typical for 510(k) submissions where clinical data is often not required if substantial equivalence can be demonstrated through other means (e.g., design, materials, intended use, non-clinical testing).

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

   • No clinical "test set" or patient data from human trials are mentioned for establishing device performance. The evaluation was done against guidance documents.

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, as no clinical test set or ground truth determination by experts for performance evaluation is described.

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

   • Not applicable for the same reason as above.

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 device is not an AI/diagnostic imaging device, an MRMC study would not be relevant.

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

   • Not applicable. This is a physical intervertebral fusion device, not an algorithm.

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

   • Not applicable. No ground truth in the context of clinical performance evaluation is mentioned. The "ground truth" for this submission is adherence to the "Class II Special Controls Guidance Document" and demonstrating substantial equivalence to the predicate device (BAK Interbody Fusion System P95002).

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" in the context of machine learning or an algorithm for this physical device.

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

   • Not applicable. No training set is involved.

In summary: The provided document is a regulatory submission demonstrating the device's substantial equivalence to a predicate device based on regulatory guidance and design principles, not a study presenting clinical effectiveness data with specific acceptance criteria and a test set. Therefore, most of your requested information regarding performance studies, sample sizes, and ground truth is not present in this document.

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PATRIOT™ Spacers (Colonial™ ACDF) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate System.

PATRIOT™ Spacers (Colonial™ ACDF) are interbody fusion devices.

This document is a 510(k) clearance letter from the FDA for a medical device called "PATRIOT Spacers". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input.

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