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The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

The proposed modified Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade Solvay Zeniva ZA-500 PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.

This 510(k) summary describes a medical device, the Transcorp ACIF System, and its modifications. It does not contain information about an AI/ML device or the results of a study designed to evaluate its performance against acceptance criteria using a test set, ground truth, or expert readers.

The document describes the performance testing for a physical implantable device, not an algorithm. The relevant section states:

"Performance testing was performed on the proposed modified IBFD. Static and dynamic axial compression, static and dynamic compression shear, and static torsion testing per ASTM F2077-11 were performed. Expulsion testing was also performed on the proposed modified IBFD. Engineering analyses were conducted to evaluate the Subsidence and Wear of the proposed modified implant. No clinical testing was performed."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML algorithm.

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The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.

The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components:

• Left and right orientation guides with 5°-15° of angulation
• Fixation pins, 12-16mm
• Drills, 2-6mm Diameter x 10-18mm Depth
• Cannulated Drills, 2-6mm Diameter x 10-18mm Depth
• Guide Pin Adapter
• Guide Pins
• Quick Disconnect Handle
• Fixation Pin Driver
• Tamp
• Mallet

The provided document describes a 510(k) premarket notification for the "Transcorp Spinal Access System." This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. The review process for 510(k) devices focuses on demonstrating substantial equivalence, rather than establishing de novo safety and effectiveness through extensive clinical trials.

Therefore, the information for acceptance criteria and a study proving the device meets those criteria will be framed within the context of a 510(k) submission and the concept of "substantial equivalence."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Study (or evidence) that proves the device meets the acceptance criteria:

The primary "study" described is a Non-Clinical Testing Summary, which included:

• Cadaver performance testing: This type of testing would assess the device's ability to be used successfully in a simulated surgical environment (on cadavers) for its intended purpose (minimally invasive access to the anterior spine).
• Functional testing: This likely involved benchtop tests to evaluate the physical and mechanical properties of the instruments (e.g., strength of drills, accuracy of guides, durability of materials).
• Comparison to the predicate: This involved direct comparison of the Transcorp system's features, materials, and performance against the legally marketed predicate device (TranS1 Trans-Sacral Spinal Access and Preparation K032891) to demonstrate similarity and equivalent performance.

The conclusion drawn from this non-clinical testing was that the Transcorp Spinal Access System is "as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device." This finding enables the FDA to determine that the new device is "substantially equivalent" to an already marketed device, which is the "acceptance criteria" for a 510(k) submission.

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

• Sample Size: The document explicitly mentions "Cadaver performance testing." While it confirms cadavers were used, it does not specify the number of cadavers used for the performance testing.
• Data Provenance: Not specified, but generally, cadaver studies for medical device testing are conducted in controlled laboratory environments. The country of origin for the data is not mentioned. The description of testing indicates a prospective assessment of the device.

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)

• The document does not specify the number or qualifications of experts involved in establishing any "ground truth" for the non-clinical tests. For cadaver and functional testing, it's typically engineers, surgeons, or anatomists who evaluate performance, but their specific involvement and qualifications are not detailed. In the context of a 510(k), the "ground truth" is largely the performance of the predicate device.

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

• The document does not mention any adjudication method as it relates to expert review or consensus for the non-clinical tests. Such methods are typically relevant for clinical studies or image interpretation tasks, which are not detailed here.

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

• No MRMC comparative effectiveness study was done. This type of study (MRMC) is generally performed for diagnostic imaging devices involving human interpretation, often when Artificial Intelligence (AI) is involved to assess its impact on reader performance. The Transcorp Spinal Access System is an instrument system, not a diagnostic imaging device with AI assistance.

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

• Not applicable. The Transcorp Spinal Access System is a set of surgical instruments, not an algorithm or software-only device. Therefore, a standalone performance assessment in the context of "algorithm only" is not relevant.

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

• For this type of device and submission, the "ground truth" is effectively:
  • Functional performance standards: Whether the instruments perform their intended mechanical actions (e.g., drills cut, guides guide).
  • Cadaveric anatomical access: Whether the system allows appropriate visualization and access to the anterior spine in cadaver models.
  • Comparison to predicate: The established safe and effective performance of the legally marketed predicate device upon which substantial equivalence is based.

8. The sample size for the training set

• Since the submission is based on non-clinical testing and comparison to a predicate, and there is no mention of an algorithm or machine learning component, there is no "training set" in the conventional sense (e.g., for AI model development).

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

• As there is no training set for an algorithm, this question is not applicable.

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The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.

Here's an analysis of the provided 510(k) summary regarding the Transcorp ACIF System, focusing on acceptance criteria and supporting studies:

Transcorp ACIF System: Acceptance Criteria and Supporting Studies

This 510(k) summary focuses on "substantial equivalence" to predicate devices rather than clinical efficacy studies often seen with AI/software devices. The acceptance criteria and supporting studies mentioned are primarily related to non-clinical performance testing of a physical implant.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that these tests were "performed" and that the results "demonstrated substantial equivalence" to predicate devices. It does not provide specific numerical outcomes or detailed acceptance ranges (e.g., maximum deflection, fatigue life cycles, subsidence amount, wear particulate size/quantity). The general statement "deemed acceptable" is inferred from the FDA's clearance based on substantial equivalence.

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

• Sample Size: Not explicitly stated for each test. For mechanical and wear testing of physical implants, a representative sample size of the manufactured device is typically used, often following industry standards for testing implantable devices (e.g., 5-10 samples per test condition).
• Data Provenance: The tests are explicitly stated as "non-clinical performance testing." This implies they were conducted in a laboratory setting, likely on manufactured prototypes or production units of the device. There is no mention of human-derived data, country of origin related to patient data, or retrospective/prospective studies as these are not relevant for this type of medical device's 510(k) clearance.

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

• Not Applicable. For this type of physical device (intervertebral body fusion device) undergoing mechanical and wear testing, "ground truth" is established by adherence to international standards (e.g., ASTM F2077-03, ASTM F2267-04, ASTM F1877-05) and internal engineering specifications, not by expert consensus on clinical data. The performance is objectively measured against physical criteria.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements in expert opinion when establishing ground truth, typically in image analysis or clinical endpoint studies. Since this device underwent non-clinical laboratory testing, such an adjudication method is not relevant.

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

• No. An MRMC study is not mentioned and would be irrelevant for a physical intervertebral body fusion device undergoing mechanical and wear testing. MRMC studies are typically performed for diagnostic imaging devices or AI-powered clinical decision support tools to evaluate human reader performance with and without AI assistance.

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

• Not Applicable. This is a physical implant, not an algorithm or software device. The concept of "standalone algorithm performance" does not apply here. The device's performance is its inherent mechanical and material properties.

7. Type of Ground Truth Used

• Objective Engineering Standards and Physical Measurements. The "ground truth" for the performance tests relies on:
  • ASTM Standards: F2077-03 (Static and Dynamic Axial Compression, Compression Shear, Torsion), F2267-04 (Subsidence), F1877-05 (Wear Debris Analysis).
  • Material Specifications: Implant grade PEEK conforming to ASTM F2026-08.
  • Comparison to Predicate Devices: Performance is likely compared to the mechanical properties and wear characteristics of the K081730 Alphatec Novel Spinal Spacer System and P980048 BAK/C Vista Cervical Interbody Fusion Device to demonstrate "substantial equivalence."

8. Sample Size for the Training Set

• Not Applicable. This device did not involve any machine learning algorithms, and therefore, there is no "training set" in the context of AI/software. If "training set" refers to samples used during product development or iteration, this information is not provided in a 510(k) summary.

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

• Not Applicable. As there is no AI/software involved and thus no "training set," this question is not relevant.

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The Transcorp Trans-Plate Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, or failed previous fusion.

The Transcorp Trans-Plate Anterior Cervical Plate System includes The Transoorp Trans Fivical plates and bone screws. The anterior cervical plate system includes a cover plate that covers the bone screws and the "window" of the plate. The cover plate is manufactured from implant grade PEEK conforming to ASTM F2026na. The plates, screws, and cover plate locking blade are manufactured from Titanium Alloy conforming to ASTM F136-08. The plate is fixated by attaching screws through holes in the plate to The plate is fixution of the vertebral body of the cervical spine (C2-C7).

Here's an analysis of the provided information regarding the Transcorp Trans-Plate Anterior Cervical Plate System's acceptance criteria and studies:

Key Takeaway: This 510(k) submission does not involve a study related to AI or any medical imaging device. It is for a mechanical spinal implant (plate and screws) and relies solely on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested points regarding AI/imaging studies, ground truth, expert consensus, and human reader performance are not applicable.

Acceptance Criteria and Reported Device Performance

The "reported device performance" for this submission is consistently stated as demonstrating equivalence to the predicate devices based on the test results. Specific numerical results are not provided in this summary document.

Further Information (Addressing all points, noting applicability)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided document. For mechanical testing of medical devices, sample sizes are typically determined by statistical requirements for engineering studies (e.g., to achieve a certain confidence level in material properties or fatigue life) rather than patient data.
   • Data Provenance: The testing was "performed on the Transcorp Trans-Plate Anterior Cervical Plate System," implying in-house or contract lab testing. It is not patient data (e.g., country of origin is not applicable). It is not retrospective or prospective clinical data. It is laboratory-based mechanical test data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This submission is for a mechanical implant and relies on standardized engineering tests (ASTM F1717, F1877). "Ground truth" in the context of expert consensus on medical findings is not relevant here. The "truth" is determined by the physical properties and performance measured against the standards.

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

   • Not Applicable. Adjudication methods are used for resolving disagreements in expert interpretations, typically in clinical studies or when establishing ground truth from imaging. For mechanical testing, the results are typically directly measured and analyzed according to the specified ASTM standards.

4. 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 or imaging device. There were no human readers involved in evaluating the performance of this mechanical implant, nor was there any AI assistance.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • Not Applicable. As noted, this is a mechanical device. The "ground truth" for its performance is derived from measurements of physical properties and mechanical behavior compared against accepted engineering standards (ASTM F1717, ASTM F1877) and against the performance of legally marketed predicate devices.

7. The sample size for the training set:

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

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

   • Not Applicable. There is no "training set" for this mechanical device.

Summary of the Study:

The "study" conducted for the Transcorp Trans-Plate Anterior Cervical Plate System was a series of non-clinical performance tests aimed at demonstrating the mechanical equivalence of the new device to established predicate devices already on the market. These tests included:

• Static Torsion (per ASTM F1717): Measures the device's resistance to twisting forces.
• Static Bending Compression (per ASTM F1717): Measures the device's resistance to forces that would bend and compress it.
• Dynamic Bending Compression (per ASTM F1717): Measures the device's fatigue life and performance under repetitive bending and compression forces.
• Wear Testing Analysis (per ASTM F1877): Assesses the generation of particulate and wear debris, which can be critical for biocompatibility and long-term implant function.

The fundamental principle behind this 510(k) submission is that if the new device demonstrates similar mechanical properties and performance characteristics to previously approved predicate devices, it can be considered "substantially equivalent" and thus safe and effective for its intended use without requiring new clinical trials or evaluations of diagnostic accuracy.

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