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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques

Qualifier:

The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:

-The KYOCERA Medical Corporation ("KYOCERA") Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.

-The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.

The Bipolar Head is for uncemented use only.

Bipolar outer heads are not for use with acetabular shells and liners.

The Renovis Surgical Hip Replacement System (K112897) includes multiple subsystem offerings, including:

• K131354: Renovis Bipolar Hip System ●
  Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification is additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation. Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K131354 Kyocera Bipolar Hip System.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance results, or any study details that would allow me to answer your request.

The document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. It discusses:

• Device name and classification.
• Intended use and indications for use.
• Comparison to a predicate device.
• Compliance with design controls and FDA guidance.

It does not contain any data from performance studies, clinical trials, or validation tests that would outline acceptance criteria and how a device achieved them. Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this specific document.

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The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

Qualifiers:
The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.
The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with the Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Cemented Hip Stem is intended for cemented applications.
The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal liners can be used with the KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

The Renovis Surgical Hip Joint Replacement System (K112897) includes multiple subsystem offerings, including:
K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
K141676: Renovis Porous Acetabular Cup System
Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI universal acetabular liners.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (hip replacement system). This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through clinical studies or AI algorithm evaluations.

Therefore, this document does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document primarily focuses on:

• Device Name: Kyocera Medical Technologies, Inc. (KMTI) Hip Replacement System, including the Tesera Trabecular Technologies (T3) Acetabular Shell System and Porous Acetabular Cup System.
• Regulatory Information: Class II device, regulation number, product codes, and predicates.
• Indications for Use: Specifies the conditions for which the hip replacement system is intended.
• Substantial Equivalence: States that there are no changes in intended use, implant materials, manufacturing, packaging, or sterilization, and that the equivalence of certain components has been demonstrated.
• Compliance: Mentions assessment under Design Controls and compliance with ISO and ASTM standards for mechanical testing.

There is no mention of AI, software algorithms, or clinical studies that would involve establishing ground truth with experts, performing multi-reader multi-case studies, or evaluating standalone algorithm performance. The "performance" discussed in this document refers to the mechanical and biological performance of the implant, typically evaluated through bench testing and material analyses to ensure safety and effectiveness, rather than a diagnostic or predictive AI algorithm's performance.

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The Renovis A400 Surgical Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
2. Rheumatoid arthritis;
3. Correction of functional deformity:
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.
   The Cemented Hip Stem is intended for cemented applications.

The Renovis Cemented Hip Stem is for use with bone cement only, is offered in multiple sizes, and is manufactured from CoCr. The taper connection of the Renovis Cemented Hip Stem is the same as the existing Renovis FDA cleared Renovis uncemented hip stems (K112897) to allow use with the existing FDA cleared femoral heads (CoCr and ceramic femoral heads; K112897 and K131354). A distal plug and distal centralizers are also offered and are manufactured from PMMA.

The provided document describes the Renovis Cemented Hip Stem and its substantial equivalence to predicate devices, but it does not detail acceptance criteria and a study proving those criteria are met in the way typically expected for an AI/CADe device. Instead, the document focuses on the regulatory clearance process for a hip implant.

Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, training set details) are not applicable to this particular type of medical device submission.

However, I can extract information related to the performance testing and materials that serve as the "acceptance criteria" and "study" for this orthopedic implant.

Here's a summary tailored to the provided document, addressing the applicable points and noting where information is not present or relevant:

Acceptance Criteria and Device Performance Study for Renovis Cemented Hip Stem

The Renovis Cemented Hip Stem received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through material compliance, design similarity, and successful performance testing according to recognized international standards. These standards implicitly define the "acceptance criteria" for the mechanical and material integrity of the implant.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document mentions "worst case Renovis stems" were tested for femoral stem fatigue. However, it does not specify the exact number of stems or individual components tested.
• Data Provenance: The document does not specify the country of origin for the data, but it is implied to be from Renovis Surgical Technologies, Inc. internal testing or contracted labs, as part of their submission to the US FDA. The studies are prospective in the sense that they were conducted specifically for the regulatory submission to demonstrate compliance with standards.

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

• This question is not applicable as the ground truth for mechanical testing of an orthopedic implant is established by compliance with a predetermined engineering standard, not by expert consensus on interpretations of data in the way an AI/CADe device would be evaluated. The "experts" are the engineers and material scientists defining and performing the tests per ISO/ASTM standards.

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

• This question is not applicable. Mechanical and material testing of implants typically relies on direct measurement and comparison against predefined thresholds within the standards, not on expert adjudication of ambiguous cases.

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 question is not applicable, as the Renovis Cemented Hip Stem is a physical implant, not an AI/CADe device intended for interpretation by human readers.

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

• This question is not applicable, as the Renovis Cemented Hip Stem is a physical implant, not a standalone algorithm.

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

• The "ground truth" for this device is derived from established international and national engineering standards for materials, mechanical performance (fatigue life), and sterilization. Successful compliance with the specifications and performance metrics outlined in these standards serves as the ground truth for the device's safety and effectiveness.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of an AI algorithm, as this is a physical medical device. The design and manufacturing processes are informed by engineering principles and prior device designs, but not in the sense of a machine learning training set.

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

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

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