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The Sargon Non-Expandable Dental Implant is indicated for immediate placement or delayed placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in partially or fully edentulous patients and to restore the patient's chewing function. This device is not indicated for immediate loading.

The Sargon Non-Expandable implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per (1 DA Classification code DEE). is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 13, and 16mm and diameters of 4.3 and 5.1mm. The surface is grit blasted and acid etched. The device is provided sterile. Sterility is achieved by gamma radiation pursuant the devilos provide a sterility assurance level (SAL) of 10°.

The provided text is a 510(k) summary for a dental implant device (K082573). It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new performance studies against specific acceptance criteria. This means the device is deemed safe and effective because it is very similar to another device that has already been cleared by the FDA.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement, as this information is not present in the provided document.

To clarify, here's what is available in the document regarding how equivalence was established:

• Basis for Substantial Equivalence: The Sargon Non-Expandable Dental Implant is claimed to be substantially equivalent to certain Strauman implants (K012757, K003271, K033984) and previously cleared Sargon expandable implants (K930071, K961005, K981141).
• Equivalence Factors: This equivalence is based on "material composition, implant dimensions (e.g., Strauman K033984; lengths 8, 10, 13, 16; diameters 3.3, 4.1, 4.6), surface treatment and individual or abutment design." It also states "There are no new indications or materials as compared with the predicate devices."

This is the extent of the performance "proof" provided in this type of submission.

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When used as an anterolateral/anterior system, the levels of attachment are the lumbar, thoracic, and cervical spine. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

When used as a nonpedicle, posterior system consisting of hooks, crosslinks, and sacral/iliac screws, the levels of attachment are the lumbar, thoracic, and cervical spine and the sacrum and ilium. The indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patient, the system is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the system is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Surgical Dynamics Spiral Radius 90-D Rodding System is to be used in conjunction with the SDRS Spinal Rods, SDRS Spinal Rod with Sacral Eye and the SDRS Locking Screw.

The Spiral Radius 90-D Rodding System consists mainly of 1) screws and hooks that are implanted in vertebral bodies and 2) rods that fit into and are locked upon the screw heads using a locking cap. The system also includes crossbars that connect 2 parallel-running rods, offset screws and clips that allow a rod to be placed in certain situations where a direct connection to the vertebrae would cause excessive bending of the rod, and rod-to-rod connectors that allow a construct to be extended. All components of the system are composed of Ti-6Al-4V which conforms to ASTM F136.

The provided text describes the 510(k) summary for the "Spiral Radius 90-D Rodding System," a spinal fixation device. The focus of the provided document is on the regulatory submission for this medical device, including its description, indications for use, and a statement on substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or any details regarding a study that would prove the device meets specific acceptance criteria.

The "TESTING" section (marked as {1} in your input) briefly mentions:

"Mechanical testing was performed, including static and dynamic compression testing and static torsion testing."

This indicates that some form of testing was done to ensure the physical properties of the device. However, it does not provide:

• Specific acceptance criteria: What were the pass/fail thresholds for the compression and torsion tests?
• Reported device performance: What were the actual values obtained from these tests?
• Comparative data: How did these results compare to the predicate device or established standards?
• Study design details: No information about sample sizes for these mechanical tests, data provenance, ground truth establishment, or any clinical study involving human readers or AI algorithms is present.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about studies involving human readers, AI, or specific ground truths, as this information is not present in the provided document.

The document's primary purpose is to establish substantial equivalence to a predicate device based on its design, materials, and intended use, rather than to report on detailed performance studies against quantitative acceptance criteria for software or diagnostic performance.

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The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a pre-selected thickness and diameter.

This DEVICE is an AC powered device consisting of three main parts: CONTROL BOX, HAND PIECE, and FOOT PEDAL. The CONTROL BOX has LED indicators, a pressure gauge, self test button, and connectors. The HAND PIECE contains the blade running and reversing mechanism, oscillation mechanism, attachment slot for the Suction Ring, Blade Holder, and a connector for the Control Box. It includes a Blade Holder, Applanation Plate (determining flap thickness), a disposable Blade, and a Single Suction Ring (fixing to the eyeball under suction). The FOOT PEDAL has switches for controlling suction, forward motion and oscillation of the blade, and reverse motion of the blade, and a cable for connection to the Control Box.

The provided text describes the Nidek Keratome, MK-2000, a Class I medical device, and its 510(k) submission for market clearance. However, it explicitly states that no clinical performance data or non-clinical performance data was provided to demonstrate the device's effectiveness.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

• No Acceptance Criteria or Reported Device Performance: The document does not define specific acceptance criteria (e.g., precision of flap thickness, success rate of flap creation) nor does it provide any reported device performance metrics against such criteria.
• No Study Data: The document explicitly states: "No clinical performance data has been provided" and "None provide" for non-clinical performance data.

Information that can be extracted from the provided text, related to your prompt, but indicating a lack of the requested data:

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

   • Acceptance Criteria: Not specified in the document.
   • Reported Device Performance: Not provided in the document.

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

   • Sample Size: Not applicable, as no test set data was provided.
   • Data Provenance: Not applicable, as no data was provided.

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):

   • Number of Experts/Qualifications: Not applicable, as no ground truth for a test set was established (no test data provided).

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

   • Adjudication Method: Not applicable, as no test set data requiring adjudication was provided.

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:

   • MRMC Study: No, the device is a Keratome (surgical instrument), not an AI diagnostic tool involving human readers.

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

   • Standalone Performance: Not applicable. The device is a surgical instrument operated by a human, not an algorithm.

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

   • Type of Ground Truth: Not applicable, as no performance data with associated ground truth was provided.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable, as no training data for an algorithm was used or described.

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

   • Ground Truth for Training Set: Not applicable, as no training data was used or described.

Summary of the document's approach to effectiveness:

The document states that the effectiveness of the device "was confirmed by use of QWF050B, Nidek MK-2000 Keratome Validation Test Procedure." However, the details or results of this procedure are not provided in the 510(k) summary. The basis for substantial equivalence is primarily stated as:

• Intended Uses and Operating & Cutting Principles are the same as six predicate devices.
• Operational Features are the same or similar to predicate devices.
• Safety Features are the same or very similar to predicate devices.
• Compliance with electrical standards (UL2601-1, IEC601-1-1, IEC601-1-2) and inclusion of operational safety features (Vacuum Level Gauge, low suction LED and tone, automatic cutting stop, foot pedal controls).

Therefore, the claim for effectiveness and safety is largely based on equivalence to already marketed devices and compliance with safety standards, rather than new performance data presented within this 510(k) summary.

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