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The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• Rheumatoid arthritis;
• · Post-traumatic arthritis,
• · Correction of functional deformity;
• · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
• · Revisions in cases of good remaining bone stock.

The Delta Acetabular System is intended for cementless use.

The Delta TT Pro is an acetabular system, intended for total hip replacement in cementless applications. The system consists of a Delta TT Pro acetabular cup (Ti6Al4V) and LimaVit liners (cross-linked UHMWPE with Vitamin E), available in three different design: neutral, protruded and high-wall. The LimaVit liners articulate with the Biolox®Delta and CoCrMo femoral heads, which are coupled to LimaCorporate femoral stems. Bone screws may be used to give further stability to the cup.

This FDA 510(k) summary is for the Delta TT Pro, a total hip prosthesis. As such, it describes a physical medical device and not a software algorithm or AI model. Therefore, many of the requested categories related to acceptance criteria for AI/software, expert review, and ground truth are not applicable.

Here's the information that can be extracted or deduced from the provided text, primarily focusing on the physical device's performance and regulatory pathway rather than AI-specific criteria.

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

The document does not provide specific numerical acceptance criteria or performance metrics for the device. Instead, it states that:

2. Sample size used for the test set and the data provenance

• Sample size: Not explicitly stated. The document refers to "extensive verification and validation testing" but does not quantify the number of devices or components tested for each type of test.
• Data provenance: Not explicitly stated, but as a physical device, the data would originate from laboratory testing of the manufactured components. The manufacturer, Limacorporate S.p.A., is located in Italy, so the testing would likely have occurred there or at a certified lab.

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

This concept is not applicable as this is a physical medical device, not an AI/software device that requires ground truth established by experts for performance evaluation. The "ground truth" for mechanical testing would be the physical properties and performance characteristics measured against established engineering standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers and AI for agreement on findings, which is not relevant for the mechanical testing of a hip prosthesis.

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 a physical device, and MRMC studies are not relevant. This type of study focuses on the diagnostic performance of human readers, typically aided by AI.

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

Not applicable. The Delta TT Pro is a physical hip prosthesis, not an algorithm.

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

As it is a physical device, the "ground truth" for its performance is based on established engineering and biomechanical principles and standards. The tests mentioned (push out, lever out, torque out, stiffness, impingement, wear) would have their results compared against these industry-accepted benchmarks and the performance of the predicate devices. The document states that the testing "confirms that the product specifications are met" and that the device operates "in a manner substantially equivalent to the predicate devices."

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device in the context of machine learning or AI.

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

Not applicable, as there is no training set for a physical device.

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The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• Rheumatoid arthritis;
• Post-traumatic arthritis,
• Correction of functional deformity;
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
• Revisions in cases of good remaining bone stock.
  The Delta TT cup is intended for cementless use.

The Delta TT Acetabular System consists of a Delta TT cup, a liner and a modular metal femoral head. Bone screws can also be used as additional fixation for the cup.
The Delta TT cup is manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3). The Delta TT cup consists of a non porous bulk interior surface and a Trabecular Titanium structure on the external surface.
The Delta TT cup has an external hemi-spherical shape. A polar threaded hole is used for introduction of the cup and mates with the polar peg of the liner when the two components are assembled. Three (3) threaded holes in lateral positions allow additional fixation of the cup using bone screws: polyethylene plugs are inserted into these holes when bone screws are not required. The Delta TT cup is designed to be coupled with ultra high molecular weight polyethylene (UHMWPE) liners by means of a taper coupling.
Delta TT cups are available with external diameters of 44, 46 and 48 mm (for Small liners), 50 and 52 mm (for Medium liners) and 54, 56, 58, 60, 62 and 64 mm (for Large liners). The new sizes of the Delta TT Cups, the Delta TT Jumbo Cups, are Delta TT Cups with external diameters of 66, 68, 70, 72, 74 and 76mm and they are all intended to be used with Large Delta TT cup liners that were cleared in K112898. The liners are manufactured from standard UHMWPE (ASTM F648 - ISO 5834-2) or from cross-linked UHMWPE (X-Lima).
Liners are coupled with the Delta TT cup by means of a taper coupling. Two features are intended to give stability to the coupling, a peripheral ring and a polar peg. The peripheral ring is manufactured from Ti6A14V (ASTM F1472 - ISO 5832-3) and surrounds the taper of the liner circumferentially, enhancing the rotational stability of the coupling. The polar peg fits into the polar hole of the cup, increasing the lever-out stability of the top of the peg is resurfaced by a Ti6Al4V (ASTM F1472 - ISO 5832-3) plug to avoid direct contact between polyethylene and bone.
The polyethylene liners are available in two (2) versions: neutral and protruded. The protruded design provides greater coverage of the femoral head and is intended to reduce the risk of dislocation. For both the designs, the following sizes are available:

• Cross-linked UHMWPE liners: Small (for femoral heads Ø 28 mm), Medium (for femoral heads Ø 28 and 32 mm) and Large (for femoral heads Ø 28, 32 and 36 mm).
• Standard UHMWPE liners: Small, Medium and Large liners for femoral heads Ø 28 mm.
  Bone screws are manufactured from Ti6Al4V (ASTM F1472 -- ISO 5832-3) and can be used to provide additional initial stability to the cup. Bone screws have a diameter of 6.5 mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60 mm.

This document describes the regulatory submission for design modifications to a hip replacement system, specifically the Delta TT Acetabular System. As such, it does not contain information about software algorithms, AI, or clinical studies that gather performance metrics like sensitivity/specificity or human reader improvement.

The information provided focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical mechanical testing.

Here's a breakdown based on the categories requested, with explanations for why certain information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria are not explicitly stated as numerical values. Instead, the document relies on the concept of "substantial equivalence" to predicate devices. The performance of the new components (Delta TT Jumbo Cups) is deemed acceptable because they do not represent a "worst case for mechanical testing" compared to the previously cleared Delta TT Cups (K112898). Therefore, the existing test results from K112898 are considered sufficient to demonstrate acceptable performance for the new sizes, implying they meet the same criteria as the original device.

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

• Sample Size: Not specified for the mechanical tests. For mechanical testing of medical devices, sample sizes are typically determined by engineering and statistical standards for the specific test (e.g., ISO or ASTM standards) and depend on the variability of the material and design. However, the document does not disclose the exact number of units tested.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were conducted to support a regulatory submission for a device manufactured by Limacorporate S.p.A. in Italy, so it's likely the testing was conducted either internally by the manufacturer or by a contracted laboratory. The testing described is non-clinical (i.e., not involving human patients or clinical data).

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

• Not applicable. This document describes mechanical testing of a physical medical device, not a diagnostic or prognostic algorithm that requires expert "ground truth" for interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation of data (e.g., medical images) needs consensus. This document pertains to mechanical engineering tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not a study involving human readers or AI assistance.

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

• No. This is not a study involving an algorithm.

7. The Type of Ground Truth Used

• Not applicable. For mechanical testing, the "ground truth" is defined by the physical behavior of the device under specific load conditions, measured by instruments, and compared against engineering specifications or results from predicate devices. There is no subjective human interpretation involved in establishing ground truth for these types of tests.

8. The Sample Size for the Training Set

• Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set or ground truth in the context of machine learning.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" in this context is a series of non-clinical mechanical tests detailed in the K112898 submission for the original Delta TT Acetabular System. The current submission (K141395) argues that because the new "Jumbo" cup sizes (66-76mm) do not represent a "worst case for mechanical testing" compared to the existing cleared sizes (44-64mm), the results from the K112898 tests are directly applicable and demonstrate substantial equivalence.

The tests conducted for K112898 (and deemed applicable for K141395) include:

• Wear test
• Push-out test
• Lever-out test
• Axial torque test
• Cup deformation test
• Fatigue/Fretting test

The underlying premise is that if the smaller, original cups performed acceptably under these mechanical tests, and the larger "Jumbo" cups are structurally similar and not more highly stressed, then they will also perform acceptably. The acceptance criteria for these tests would have been established based on recognized industry standards (e.g., ASTM, ISO) for hip prostheses at the time of the K112898 submission. The document relies on the previous clearance to establish that these criteria were met.

Clinical Testing: The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the Delta TT Jumbo Cups to the Delta TT Acetabular System." This further emphasizes that the basis for clearance was non-clinical mechanical performance.

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The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular . necrosis and hip dysplasia;
• Rheumatoid arthritis; .
• Post-traumatic arthritis, .
• Correction of functional deformity; .
• Fractures, dislocation of the hip and unsuccessful cup arthroplasty. ●
• Revisions in cases of good remaining bone stock. .

The Delta TT cup is intended for cementless use.

The Delta TT Acetabular System consists of a Delta TT cup, a liner and a modular metal femoral head. Bone screws can also be used to give further stability to the cup.

The Delta TT cup is manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3). The Delta TT cup consists of a non porous bulk interior surface and a Trabecular Titanium structure on the external surface.

The Delta TT cup has an external hemi-spherical shape. A polar threaded hole is used for introduction of the cup and mates with the polar peg of the liner when the two components are assembled. Three threaded holes in lateral positions allow additional fixation of the cup using bone screws (polyethylene plugs are used when bone screws are not required). The Delta TT cup is designed to be coupled with ultra high molecular weight polyethylene (UHMWPE) liners by means of a taper coupling.

Delta TT cups are available with external diameters of 44, 46 and 48 mm (for Small liners), 50 and 52 mm (for Medium liners) and 54, 56, 58, 60, 62 and 64 mm (for Large liners).

The liners for Delta TT cups are manufactured from standard UHMWPE (ASTM F648 -ISO 5834-2) or from cross-linked UHMWPE (X-Lima).

Liners are coupled with the Delta TT cup by means of a taper coupling. Two features are intended to give stability to the coupling. A peripheral ring manufactured from Ti6A14V (ASTM F1472 - ISO 5832-3) surrounds the taper of the liner circumferentially, enhancing the rotational stability of the coupling. A polar peg fits into the of the cup, increasing the lever-out stability of the liner. The top of the peg is resurfaced by a Ti6A14V (ASTM F1472 - ISO 5832-3) plug to avoid direct contact between polyethylene and bone.

Liners are available in two versions: neutral and protruded. The protruded design provides greater coverage of the femoral head and is intended to reduce the risk of dislocation. For both the designs, the following sizes are available:

• Cross-linked UHMWPE liners: Small (for femoral heads Ø 28 mm), Medium (for . femoral heads Ø 28 and 32 mm) and Large (for femoral heads Ø 28, 32 and 36 mm).
• Standard UHMWPE liners: Small, Medium and Large liners for femoral heads Ø 28 . mm.

Bone screws are manufactured from Ti6A14V (ASTM F1472 - ISO 5832-3) and can be used to provide additional initial stability to the cup. Bone screws have a diameter of 6.5 mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60 mm.

The provided text is a Summary of Safety and Effectiveness for the Limacorporate S.p.A. Delta TT Acetabular System. This document describes a medical device (hip implant components) and its comparison to legally marketed predicate devices to establish substantial equivalence for regulatory approval (510(k)).

As such, this document does not contain information about acceptance criteria for an AI/software device, nor does it describe a study to prove an AI/software device meets acceptance criteria. The information requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) pertains specifically to the validation of AI/software devices, which is not applicable to the physical medical device described in this text.

The closest relevant information, if we were forced to extrapolate, would be:

• "Acceptance Criteria" (interpreted as performance targets): The device aims to perform comparably to its predicate devices, as demonstrated through non-clinical bench testing. The criteria for success are implicit in "demonstrate the strength of the cup-liner modular connection," "wear tests," "ensure the device design does not overly limit range of motion," and "characterization for tensile, yield, elongation and rotating beam fatigue properties" that "were compared with standard materials used for the manufacturing of predicate acetabular cups."
• "Study that proves the device meets the acceptance criteria": The non-clinical bench testing described, which includes:
  • Deformation testing
  • Fatigue-fretting of the metal shell
  • Push-out, lever-out, and torque-out testing (for cup-liner modular connection strength)
  • Wear tests for the liners
  • Range of Motion simulation
  • Two-point fatigue testing to failure for Delta TT cups (compared with FMP cups using the same protocol)
  • Characterization of EBM Ti6Al4V for tensile, yield, elongation, and rotating beam fatigue properties (compared with standard materials)
  • Biocompatibility testing

However, to reiterate, this is a document for a physical orthopedic implant seeking 510(k) clearance, not an AI/software as a medical device. Therefore, the specific requirements of your prompt are not met by the provided text.

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The Sigma Delta 'T' vaporizer range is designed to attach to the back bar of an anaesthetic machine and deliver controlled concentrations of anaesthesia gasses into a fresh gas. The fresh gas is then delivered into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient. The Vaporizer is calibrated in Vol % of the fresh gas flow and is compensated for changes in both fresh gas flows and temperature changes within the specified range. The indicated use of the Sigma Delta 'T' has therefore not changed from that of the legally marketed device the Sigma Delta.

Anaesthetic Vaporizer

This document is a 510(k) premarket notification decision letter from the FDA for an "Anaesthetic Vaporizer." It does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging diagnostics. The device described is a traditional medical device (anesthetic vaporizer), not a software device that would typically have performance metrics like sensitivity, specificity, and a ground truth study.

Therefore, I cannot provide the requested information.

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