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RENOVA SPINE BALLOON CATHETER is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).

The RENOVA SPINE BALLOON CATHETER is a single use disposable sterile device available in 3 different models depending on the dimensions of the balloon: 10 mm, 15 mm and 20 mm.
RENOVA SPINE BALLOON CATHETER is a single use catheter (double lumen tube) with a balloon at the distal end.
The balloon catheter is normally inserted through a needle / working cannula and inflated through an inflation device.
The catheter has two separate lumens connected to a Y connector at the proximal end of the catheter. The outer lumen of the catheter is used to inflate the balloon while the central lumen contains a removable stylet used to aid in the introduction of the balloon catheter.

The provided text does NOT describe a study involving an AI/ML powered medical device. Instead, it is a 510(k) premarket notification for a medical device called the "RENOVA SPINE BALLOON CATHETER." This device is used in balloon kyphoplasty and is a physical, non-software device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing of its physical properties.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, as the document does not contain any details related to AI/ML device performance, ground truth establishment, expert adjudication, or clinical studies involving AI assistance.

The content discusses:

• Device Name: Renova Spine Balloon Catheter
• Intended Use: Reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty.
• Predicate Device: InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini) (K150322)
• Performance Data: This section refers to mechanical tests conducted on the physical device, such as Balloon Deflation Time, Burst Pressure, Fatigue Strength, etc. These are standard engineering tests for physical medical devices, not AI/ML model performance metrics.
• Clinical Data: Stated as "N/A," indicating no human clinical trials were required for this submission, which is common for 510(k)s demonstrating substantial equivalence based on physical and functional similarity to an existing device.

Without information about an AI/ML component, it is impossible to answer the specific questions related to AI/ML device acceptance criteria and study methodology.

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The BONE MARROW MSC ASPIRATION KIT is intended for use for aspiration / explant of bone marrow through a piston syringe.

The BONE MARROW MSC ASPIRATION KIT is a single use disposable needle intended for the aspiration / explant of bone marrow. The structure of BONE MARROW MSC ASPIRATION KIT device includes a cannula with a stylet inside, with a threaded insert and a rotating spacer that allow the precise retraction of the cannula to a determined length. Once the cannula has been inserted and positioned, the stylet can be removed and a syringe is connected to execute the aspiration. By manually rotating the rotating spacer, the cannula retracts, raising inside the bone marrow, in order to be able to perform aspiration / explant from fresh sites at different heights.

The provided document is a 510(k) Premarket Notification for the "BONE MARROW MSC ASPIRATION KIT". This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, meaning they generally do not require extensive de novo clinical studies to prove effectiveness in the same way a new drug or novel medical device might. The document focuses on demonstrating substantial equivalence rather than presenting a detailed study proving device meets specific clinical acceptance criteria in a comparative effectiveness study with human readers or standalone performance.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC study effect size, type of ground truth for test and training sets) are not typically included in a 510(k) for a device like a bone marrow aspiration kit, as the primary evidence provided is performance data from design verification and validation testing, and comparison to predicate devices, rather than clinical efficacy data.

Here's a breakdown of the information that can be extracted and what is not available in the document:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in a single, clear format for clinical outcomes. Instead, it lists performance/functionality/safety tests and states that the "Results of the evaluations demonstrate that the subject device met the safety and performance requirements as per its indication for use."

However, we can infer some criteria from the tests performed:

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

The document does not provide details on sample sizes for each test listed under "Performance Data." These are typically engineering and laboratory verification and validation tests, not clinical trials with human subjects. Thus, information on "country of origin of the data" or "retrospective or prospective" is not applicable in the context of these engineering tests.

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

Not applicable. The performance data presented are from technical/engineering tests, not clinical evaluations requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set

Not applicable. This typically refers to resolving discrepancies in expert interpretations in clinical studies, 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. This device is a bone marrow aspiration kit, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

No. This is a physical medical device, not an algorithm.

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

The document indicates "Performance Data" obtained through various engineering and functional tests (e.g., biocompatibility testing, mechanical performance testing, sterilization validation). The "ground truth" for these types of tests would be adherence to established engineering standards, material specifications, and regulatory requirements (e.g., ISO 10993 for biocompatibility). There is no "expert consensus, pathology, or outcomes data" mentioned in the context of establishing ground truth for these device performance tests.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is a physical device and not an AI/machine learning model.

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

Not applicable.

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The DISKOM is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thorace and cervical regions of the spine.

The DISKOM is a single use, active, EO sterilized device, that shall be used by specialized personnel during discectomy procedures. The DISKOM is a disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus. DISKOM is composed by an INTRODUCER NEEDLE and a DISCECTOMY PROBE. The INTRODUCER NEEDLE is made of an aspiration cannula and an introducer stylet. The introducer needle is positioned on the disc (using CT / Fluoroscopic guide), then the stylet is removed and the cannula is used to position the discectomy probe. The DISCECTOMY PROBE contains a battery source DC motor that causes the internal mechanism to act as a screw conveyor to remove and retrieve the excised debris of the spine through the outer cannula and into the transparent collection container. The DISKOM is provided in two different models with two different cannula lengths (16cm and 8cm) and two different gauges cannulas (17G and 19G).

The DISKOM device, a percutaneous discectomy device for aspiration of disc material, was evaluated through non-clinical performance and biocompatibility testing. No clinical studies were performed.

Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA's review for this 510(k) notification focused on establishing substantial equivalence to predicate devices, rather than setting specific numerical acceptance criteria for clinical performance. The acceptance criteria were primarily based on demonstrating comparable technological characteristics, intended use, and satisfactory performance in non-clinical tests.

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

The summary indicates that non-clinical tests were performed. It does not specify a "test set" in the context of patient data or clinical images. For the performance tests, it mentions "all BIOPSYBELL DISKOM codes" were tested, and refers to "newly manufactured and aged products." The exact number of devices tested for each performance parameter is not specified.

• Sample Size: Not explicitly stated for each non-clinical test, but implied to be sufficient for demonstrating performance by testing "all BIOPSYBELL DISKOM codes" and both "newly manufactured and aged products."
• Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Biopsybell s.r.l. in Italy). Therefore, there is no "country of origin of the data" in the clinical sense, and the data is generated specifically for this submission. The tests are prospective in nature, as they were conducted to obtain regulatory clearance.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. This was a non-clinical study, so there was no "ground truth" established by experts in the context of clinical interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

5. MRMC Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical test were performed on the subject device." Therefore, there is no effect size of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The DISKOM device is a mechanical arthroscope/discectomy probe, not an artificial intelligence (AI) algorithm or software-only device. Its performance is related to its mechanical and electrical function, not an AI output.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by direct measurement and adherence to predefined engineering specifications and international standards. For example:

• Biocompatibility: Conformance to ISO 10993 standards.
• Electrical Safety/EMC: Conformance to IEC 60601-1 and EN 60601-1-2 standards.
• Performance tests: Measurements of parameters like run time, RPM, temperature, and radiopacity against internal design specifications and predicate device characteristics, as well as accepted engineering principles.

8. Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

Not applicable. This device does not involve a training set.

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The medical devices object of this 510K are all needles for biopsy. The products could be classified in 3 families that are:

• the needles for bone-marrow biopsy (In this family of needles for bone-marrow biopsy there is also a little group of devices intended for bone-marrow explants). In particular the indications for use for each different model are the followings:

OSTEOBELL 'T': Needle for bone-marrow biopsy
ORION: Needle for bone-marrow biopsy
ILIAC-MARROW: Needle for bone-marrow biopsy
OBSTERN: Needle for bone-marrow biopsy
STERNOBELL: Needle for bone-marrow biopsy
TOTALLY REMOVE: Needle for bone-marrow biopsy
UNLUX SYSTEM: Needle for bone-marrow biopsy
OSTEOBELL EXPLANT: Needle for bone-marrow explant
ORION EXPLANT: Needle for bone-marrow explant
ILIAC-MARROW EXPLANT: Needle for bone-marrow explant
OBSTERN EXPLANT: Needle for bone-marrow explant
STERNOBELL EXPLANT: Needle for bone-marrow explants

• the semiautomatic quillotine needles for soft-tissue biopsy (breast, kidney, liver, prostate):
  SPEEDYBELL: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)
  SPEEDYBELL DOPPIA CORSA: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)

SPEEDYBELL & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)

SPEEDYBELL DOPPIA CORSA & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)

• the automatic guillotine needles for soft-tissues biopsy (liver):
  ESTER: automatic quillotine needle for soft-tissue biopsy (liver)
  ESTER & INTRODUTTORE: automatic guillotine needle for soft-tissue biopsy (liver)

The medical devices object of this 510K are all needles for biopsy, used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination (biopsy). The devices could be classified in 3 families that are:

• the needles for bone-marrow biopsy,
• the semiautomatic guillotine needles for soft-tissue biopsy and
• the automatic quillotine needles for soft-tissue biopsy.

All the needles are single use and sterile (ETO sterilization).

All the needles are composed with an external cannula (tube) and an internal stylet (mandrel) both in AISI 304 stainless steel. The grip of the needles is in plastic (different depending from the model).

The provided document describes the acceptance criteria and the studies conducted to demonstrate the safety and effectiveness of Biopsybell S.R.L.'s biopsy needles. The studies are non-clinical bench tests performed on three families of biopsy needles: needles for bone-marrow biopsy, semiautomatic guillotine needles for soft-tissue biopsy, and automatic guillotine needles for soft-tissue biopsy.

Here's an organized summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Family 1: Needles for Bone-Marrow Biopsy (Test Report n°59/10 dated 08/11/2010)

Family 2: Semiautomatic Guillotine Needles for Soft-Tissue Biopsy (Test Report n°67 dated 08/11/2010)

Family 3: Automatic Guillotine Needles for Soft-Tissue Biopsy (Test Report n°68 dated 30/04/2012)

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

The studies are non-clinical bench tests. The document does not specify exact numerical sample sizes for each test in terms of "n=". Instead, it states that:

• Family 1 (Bone-Marrow): "2 model of products that are the worst case of all the other models" (ILIAC MARROW and TOTALLY REMOVE) were used. The "sterile devices have been utilized for each code in the test samples." The tests included "repeatedly tested" for handle grip and "three different trials" for Luer-lock.
• Family 2 (Semiautomatic Soft-Tissue): "Five samples" of 'Speedybell doppia corsa' (worst case model) were used, manufactured in "four different lots, having 14G, 16G and 18G diameters and lengths ranging from 70mm, 100 mm." Tests were conducted both at 1cm and 2cm shots.
• Family 3 (Automatic Soft-Tissue): 'Ester' devices of different diameters and lengths (16G and 18G diameters, 100 mm and 150 mm lengths) from "different lots" were used.

Data Provenance:
The data provenance is retrospective, as these were bench tests performed by the manufacturer (Biopsybell S.R.L.) as part of their 510(k) submission. The tests involved the use of animal tissues (calf femur, liver, muscle), and artificial tissues (expanded polyurethane, apples). The country of origin for the studies is implied to be Italy, where Biopsybell S.R.L. is located.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The ground truth in these bench tests was established through direct observation and measurement of the physical properties and performance of the devices by the testing personnel. The document does not specify the "number of experts" or their "qualifications" in the sense of clinical experts (like radiologists). The "ground truth" was based on objective physical testing, visual inspection, and measurement by technical personnel responsible for conducting the bench tests. For example, "visually tested" and "carefully reviewed and measured."

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1, 3+1 consensus) is described, as the "ground truth" for these bench tests was based on direct physical observations, measurements, and functional assessments performed by the testing team. The results were reported directly from these tests.

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

No MRMC comparative effectiveness study was done. The studies are non-clinical bench tests evaluating the physical and functional performance of the biopsy needles, not diagnostic accuracy or human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (biopsy needles), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used was based on objective physical measurements, functional assessments, and visual inspection of the device's performance in different tissue types (animal and artificial). This included:

• Ease of penetration (visual/manual assessment)
• Integrity and quantity of collected samples (measurement, video-microscope examination)
• Mechanical function (Luer-lock compliance, shot completion, handle integrity)

8. Sample Size for the Training Set

Not applicable. These are non-clinical bench tests of a physical device, not an AI model, so there is no "training set."

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

Not applicable, as there is no training set for an AI model.

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