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The TORPEDO Implant System® is intended for sacroiliac fusion for the following indications:

· Sacroiliac joint dysfunction that is a direct result of sacrolliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Deltacor TORPEDO Implant System® consists of canulated spiral-shaped titanium implants (CP Ti Grade 4, ASTM F67) and a placement. The structured surface and special shape of the implant is intended to prevent rotation or displacement of the sacroiliac joint (SI). The cannulated implant can be augmented into the bone in a controlled manner using the laterally inserted holes between the helix. The placement instrument uses a guide wire to achieve precise placement. The TORPEDO Implant System® offers a minimally invasive option for treating SI joint dysfunction.

The medical device in question, the TORPEDO Implant System®, is a canulated spiral-shaped titanium implant designed for sacroiliac fusion. This document focuses on the performance testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria specific to its AI functionality.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for device performance in the way one might expect for software or diagnostic AI. Instead, it details various mechanical tests and their corresponding ASTM standards, implying that meeting these standards or demonstrating comparable performance to predicate devices is the acceptance criterion.

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

The document refers to "non-clinical and clinical data" but does not explicitly detail the sample size for the test set in the context of device performance. The "clinical data" mentioned are general, including "sales and complaints data, clinical literature, and patient-level clinical data." This suggests that the clinical evidence relies on a broader compilation rather than a distinct, prospectively designed test set with a defined sample size for performance evaluation like an AI study would have.

The provenance of the data is not specified in detail (e.g., country of origin, retrospective or prospective for the "patient-level clinical data").

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

This information is not applicable as the device is a physical implant and not an AI/software device that relies on expert ground truth for its performance assessment. The "ground truth" for this type of device is established through mechanical testing, material science, and clinical outcomes (as observed in existing literature and patient data), rather than expert consensus on image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of data (e.g., medical images) where discrepancies need to be resolved to establish ground truth.

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:

This information is not applicable as the device is a physical implant and not an AI system. Therefore, it does not involve human readers interpreting data with or without AI assistance.

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

This information is not applicable as the device is a physical implant and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For this physical device, the "ground truth" is derived from:

• Mechanical Testing: Adherence to defined ASTM standards for static torsion, axial pull-out, and bending fatigue.
• Biocompatibility: Demonstrated equivalence to similar devices with established biological safety.
• Clinical Data: General "sales and complaints data, clinical literature, and patient-level clinical data" which would implicitly reflect real-world outcomes and safety profiles, aligning with the concept of "outcomes data" to support its safety and effectiveness.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical implant, not an AI model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.

The BoneTrust® Mini Implant System is a two-piece dental implant system including various sizes of threaded root-form dental implants and abutments to provide temporary support of prosthetic restorations in edentulous or partially edentulous patients during the healing phase of permanent endosseous dental implant(s). The maximum duration of intraoral use of all members of the BoneTrust® Mini Implant System is 180 days.

The provided text describes a 510(k) premarket notification for the BoneTrust® Mini Implant System. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a new device meets specific performance acceptance criteria through the types of studies typically conducted for novel AI/ML-driven medical devices.

Therefore, the requested information about acceptance criteria tables, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not present in this document. This document primarily relies on a comparative analysis of:

• Indications for Use: The BoneTrust® Mini Implant System's intended use is compared to that of primary and reference predicate devices (EM Provisional, Sterngold 2.2mm Angled Micro ERA Dental Implant System, BoneTrust® Implant Systems, MIS LOCKIT Abutments System, Nobel Biocare AB, OSSTEM Implant Co. Ltd.). The conclusion is that the indications are "Similar to primary predicate device" or "Substantially Equivalent." The additional limitation of implant duration (max 180 days) is noted as not changing the intended use.

• Technological Characteristics: Detailed comparisons are made regarding:

  • Implant Material: Titanium Grade 4 ASTM F67, identical to reference device K182313.
  • Implant Type and Design: Screw-type, straight body/tapered body, self-tapping, with thread, two-piece design. Largely identical or similar to predicate/reference devices.
  • Implant-Abutment Connection: External Torx Implant/Abutment fixture. Differences from some predicates (one-piece design or different connection types) are stated not to raise concerns regarding safety and effectiveness.
  • Implant Dimensions: The proposed device's sizes (diameters and lengths) are stated to be "within range of primary predicate device."
  • Surface Treatment: Machined / Microstructured blasted etched surface passivated, stated as identical to K191751 and K182313.
  • Sterilization: Beta Radiation, identical to K182313.
  • Abutment Material, Surface, Size, Connection, Angulation, and Sterility: Comparisons are made to various predicate/reference abutments, with conclusions of "Identical" or minor differences not raising safety/effectiveness concerns.
  • Ball Attachment Material, Surface, Size, Connection, Angulation, and Sterility: Similar comparisons are made, concluding "Identical" or differences not impacting safety/effectiveness.

• Non-Clinical Testing Summary:

  • Clinical Studies: None were performed.
  • Biocompatibility: Relied on previous clearance of BoneTrust® Implant System (K182313) due to identical manufacturing process and materials. Periodic bacterial endotoxin testing (USP ) is performed, with historical data showing acceptable levels.
  • Fatigue Testing: Not deemed necessary as per FDA Guidance Document for Class II Special Controls, because the system does not contain angulated abutments.
  • Sterilization: Beta-radiation sterilized (SAL 10⁻⁶) according to ISO 11137-1:2006 and 11137-2:2013. Efficacy reliant on K182313 due to identical process. Unsterile prosthetic components are intended for end-user sterilization, with methods identical to K182313.
  • Shelf Life: 5 years, reliant on K182313 due to identical packaging system.
  • Implant Surface Analysis: Energy Dispersive X-ray Spectroscopy (EDX) and SEM analysis were conducted, and results support substantial equivalence to legally marketed predicate devices.

In summary, there is no study described in this document that proves the device meets specific acceptance criteria in the manner requested, because the submission focuses on demonstrating substantial equivalence to existing devices through comparative analysis and non-clinical testing rather than de novo clinical or performance studies with defined acceptance criteria for a novel AI/ML device.

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The ST Internal Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ST Internal Implant System are made with Grade 4 titanium and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this system are ST internal implant, screw and abutment. The implants in this system are provided in lengths from 7.0-15.0 and in diameters from 3.7-5.1. The 3.7 diameter implant is not provided in the 7.0 length. The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.

The provided text describes a 510(k) premarket notification for a medical device, the "ST Internal Implant System." The approval is based on a determination of substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria based on human performance.

Therefore, many of the requested details about acceptance criteria, study design with human readers, and ground truth establishment (especially for AI or image analysis devices) are not applicable (N/A) to this 510(k) submission. The performance testing focuses on mechanical and biological properties of the dental implant itself, not on an algorithm's ability to interpret data.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but does not provide a specific table of quantitative acceptance criteria for all performance parameters and their corresponding reported values in a standardized format. Instead, it states:

• Sterilization Test: "leveraged from own K132992 predicate" - implies meeting standards leveraged from prior approval.
• Shelf Life Test: "leveraged from own K132992 and K152787 predicate" - implies meeting standards leveraged from prior approval.
• Biocompatibility testing:
  • Cytotoxicity Test
  • Intracutaneous Reactivity Test
  • Maximization Sensitization Test
  • Systemic Injection Test (Intravenous Injection)
  • Pyrogen Test
  • "All the test results demonstrate that ST Internal Implant System meets the requirements of its pre-defined acceptance criteria and intended use." (General statement, no specific values given).
• 90-Day Bone Implantation Study: Listed as performed.
• Fatigue test:
  • Acceptance Criteria Statement: "A fatigue test is required to evaluate the stability of implant system in oral cavity. The fatigue testing has been conducted on the proposed device in accordance with ISO 14801."
  • Reported Performance: "Test results comply with ISO14801." (No specific numerical values or pass/fail thresholds are explicitly provided in the document, only a statement of compliance).
• SLA surface treatment (cleaning validation and SEM/EDX analysis):
  • Acceptance Criteria Statement: "to verify that any particles or chemicals used to remove particles have been washed from the surface."
  • Reported Performance: "The SEM/EDX analysis verifies that there were no elements besides titanium found on the surface of the implant."

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

• Sample Size for Test Set: Not specified for any of the non-clinical tests (e.g., number of implants tested for fatigue). These are typically lab-based tests, not human data.
• Data Provenance: The device manufacturer, T-Plus Implant Tech. Co., Ltd., is located in Taiwan. The tests are "non-clinical testing," implying laboratory or animal studies, not human data from a specific country.
• Retrospective or Prospective: N/A for these non-clinical tests.

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

• N/A. The testing described is for the physical and biological properties of a dental implant, not for an algorithm where expert radiologist ground truth would be established. The ground truth for mechanical and biocompatibility tests are defined industry standards (e.g., ISO 14801) and established laboratory protocols.

4. Adjudication Method for the Test Set

• N/A. Not relevant for non-clinical, lab-based performance tests of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, N/A. This type of study is relevant for diagnostic imaging AI systems and not for a dental implant's mechanical or biological performance.

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

• N/A. The device is a dental implant, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical testing (e.g., fatigue), the ground truth is compliance with international standards (ISO 14801).
• For biocompatibility, the ground truth is compliance with established biological safety requirements (e.g., ISO 10993 series through tests like cytotoxicity, sensitization, implantation, etc.).
• For surface analysis, the ground truth is the absence of foreign elements as determined by analytical techniques like SEM/EDX.

8. The Sample Size for the Training Set

• N/A. This device does not involve machine learning or AI, so there is no "training set."

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

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

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